Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-02 @ 5:04 PM
Study NCT ID:
NCT00677235
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2008-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post-Approval Study for the FLAIR Endovascular Stent Graft
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003251', 'term': 'Constriction, Pathologic'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'John.VanVleet@CRBard.com', 'phone': '1-800-321-4254', 'title': 'John Van Vleet', 'organization': 'Bard Peripheral Vascular'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Index Procedure through 24 months of follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'FLAIR', 'description': 'FLAIR Endovascular Stent Graft\n\nFLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft', 'otherNumAtRisk': 138, 'otherNumAffected': 128, 'seriousNumAtRisk': 138, 'seriousNumAffected': 84}, {'id': 'EG001', 'title': 'PTA Only', 'description': 'Percutaneous Transluminal Angioplasty\n\nPTA: Treatment of stenoses with PTA only', 'otherNumAtRisk': 132, 'otherNumAffected': 127, 'seriousNumAtRisk': 132, 'seriousNumAffected': 87}], 'otherEvents': [{'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Congestive heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Significant arm or hand edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Steal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Stenosis requiring intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 82, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 103, 'numAffected': 103}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Thrombotic occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 47, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 45, 'numAffected': 45}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vessel rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Congestive heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'hemotoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 33, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Significant arm or hand edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Stenosis requiring intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Thrombotic occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 69, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 69, 'numAffected': 69}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'ACPP Was Defined as the Interval Following the Index Procedure Until the Next Access Thrombosis or Reintervention.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLAIR', 'description': 'FLAIR Endovascular Stent Graft\n\nFLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft'}, {'id': 'OG001', 'title': 'PTA Only', 'description': 'Percutaneous Transluminal Angioplasty\n\nPTA: Treatment of stenoses with PTA only'}], 'classes': [{'categories': [{'measurements': [{'value': '0.240', 'groupId': 'OG000', 'lowerLimit': '0.165', 'upperLimit': '0.315'}, {'value': '0.110', 'groupId': 'OG001', 'lowerLimit': '0.054', 'upperLimit': '0.167'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'To demonstrate that the post intervention Access Circuit Primary Patency (ACPP) of FLAIR™ is superior to that of PTA at 12 months post study procedure.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who were enrolled in the study were included in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).'}, {'type': 'PRIMARY', 'title': 'The Index of Patency Function (IPF) [the Average Number of Months Between Interventions] of FLAIR™ is Not Inferior to That of PTA at 12 Months Post Study Procedure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLAIR', 'description': 'FLAIR Endovascular Stent Graft\n\nFLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft'}, {'id': 'OG001', 'title': 'PTA Only', 'description': 'Percutaneous Transluminal Angioplasty\n\nPTA: Treatment of stenoses with PTA only'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '4.08', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '3.51', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'The IPF is summarized was defined as the time from the index study procedure to complete graft abandonment divided by the number of visits for a reintervention performed on the arteriovenous (AV) access circuit in order to maintain vascular access for hemodialysis.', 'unitOfMeasure': 'Months/intervention', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who were enrolled in the study will participate in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).Blackwelder t-test testing non-inferiority of the FLAIR® group to that of PTA.'}, {'type': 'PRIMARY', 'title': 'The Number of Participants With Device and/or Procedure Related Adverse Events at 12 Months Post Study Procedure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLAIR', 'description': 'FLAIR Endovascular Stent Graft\n\nFLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft'}, {'id': 'OG001', 'title': 'PTA Only', 'description': 'Percutaneous Transluminal Angioplasty\n\nPTA: Treatment of stenoses with PTA only'}], 'classes': [{'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'unitOfMeasure': 'Number of Participants with Device and/o', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'To Assess the Number of Re-interventions to the Access Circuit Until Graft Abandonment or Through 12 Months Post-index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLAIR', 'description': 'FLAIR Endovascular Stent Graft\n\nFLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft'}, {'id': 'OG001', 'title': 'PTA Only', 'description': 'Percutaneous Transluminal Angioplasty\n\nPTA: Treatment of stenoses with PTA only'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '2.18', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '2.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Patient Follow-Up', 'description': 'The estimated number of re-interventions to the access circuit until graft abandonment or through 12 months post-index procedure was a secondary endpoint without hypothesis testing and is therefore summarized descriptively.', 'unitOfMeasure': 'reinterventions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-Intervention Assisted Primary Patency at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLAIR', 'description': 'FLAIR Endovascular Stent Graft\n\nFLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft'}, {'id': 'OG001', 'title': 'PTA Only', 'description': 'Percutaneous Transluminal Angioplasty\n\nPTA: Treatment of stenoses with PTA only'}], 'classes': [{'categories': [{'measurements': [{'value': '0.497', 'groupId': 'OG000', 'lowerLimit': '0.410', 'upperLimit': '0.584'}, {'value': '0.563', 'groupId': 'OG001', 'lowerLimit': '0.474', 'upperLimit': '0.653'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-intervention Secondary Patency (PSP) at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLAIR', 'description': 'FLAIR Endovascular Stent Graft\n\nFLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft'}, {'id': 'OG001', 'title': 'PTA Only', 'description': 'Percutaneous Transluminal Angioplasty\n\nPTA: Treatment of stenoses with PTA only'}], 'classes': [{'categories': [{'measurements': [{'value': '0.653', 'groupId': 'OG000', 'lowerLimit': '0.569', 'upperLimit': '0.736'}, {'value': '0.710', 'groupId': 'OG001', 'lowerLimit': '0.629', 'upperLimit': '0.792'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Postintervention secondary patency \\[PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial\\] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLAIR', 'description': 'FLAIR Endovascular Stent Graft\n\nFLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft'}, {'id': 'OG001', 'title': 'PTA Only', 'description': 'Percutaneous Transluminal Angioplasty\n\nPTA: Treatment of stenoses with PTA only'}], 'classes': [{'categories': [{'measurements': [{'value': '81.2', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Patient Follow-Up', 'description': 'Procedural success was a secondary endpoint without hypothesis testing and is therefore summarized descriptively. Procedural success is defined as anatomic success and at least one indicator of hemodynamic or clinical success.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Analysis of Proportion of Serious Adverse Events Classified as Device and/or Procedure-Related Through 30 Days Post-Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLAIR', 'description': 'FLAIR Endovascular Stent Graft\n\nFLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft'}, {'id': 'OG001', 'title': 'PTA Only', 'description': 'Percutaneous Transluminal Angioplasty\n\nPTA: Treatment of stenoses with PTA only'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Patient Follow-Up', 'description': 'The incidence of device-related and procedure-related serious adverse events (SAEs) from the index procedure through 30 days post procedure is summarized. The purpose of this analysis was to assess the effectiveness of the Bard Peripheral Vascular (BPV) clinician training program.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Demonstrate Non-inferiority of FLAIR Safety in Terms of Serious Adverse Events at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLAIR', 'description': 'FLAIR Endovascular Stent Graft\n\nFLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft'}, {'id': 'OG001', 'title': 'PTA Only', 'description': 'Percutaneous Transluminal Angioplasty\n\nPTA: Treatment of stenoses with PTA only'}], 'classes': [{'categories': [{'measurements': [{'value': '60.9', 'groupId': 'OG000'}, {'value': '65.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.449', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Serious Adverse Events at 12 months are reported for all 270 subjects.', 'unitOfMeasure': 'percentage of participants with serious', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Access Circuit Primary Patency (ACCP) at 24 Months Procedure Until the Next Access Thrombosis or Reintervention.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLAIR', 'description': 'FLAIR Endovascular Stent Graft\n\nFLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft'}, {'id': 'OG001', 'title': 'PTA Only', 'description': 'Percutaneous Transluminal Angioplasty\n\nPTA: Treatment of stenoses with PTA only'}], 'classes': [{'categories': [{'measurements': [{'value': '0.095', 'groupId': 'OG000', 'lowerLimit': '0.029', 'upperLimit': '0.162'}, {'value': '0.055', 'groupId': 'OG001', 'lowerLimit': '0.013', 'upperLimit': '0.097'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Access Circuit Primary Patency (ACPP) was defined as the interval following the index procedure until the next access thrombosis or reintervention at 24 months.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who were enrolled in the study were included in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).'}, {'type': 'SECONDARY', 'title': 'To Estimate Safety at 24 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLAIR', 'description': 'FLAIR Endovascular Stent Graft\n\nFLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft'}, {'id': 'OG001', 'title': 'PTA Only', 'description': 'Percutaneous Transluminal Angioplasty\n\nPTA: Treatment of stenoses with PTA only'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'To estimate the percentage of participants without safety issues through 24 months.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-Intervention Assisted Primary Patency at 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLAIR', 'description': 'FLAIR Endovascular Stent Graft\n\nFLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft'}, {'id': 'OG001', 'title': 'PTA Only', 'description': 'Percutaneous Transluminal Angioplasty\n\nPTA: Treatment of stenoses with PTA only'}], 'classes': [{'categories': [{'measurements': [{'value': '0.384', 'groupId': 'OG000', 'lowerLimit': '0.282', 'upperLimit': '0.486'}, {'value': '0.406', 'groupId': 'OG001', 'lowerLimit': '0.312', 'upperLimit': '0.500'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 month follow up', 'description': 'Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-intervention Secondary Patency at 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLAIR', 'description': 'FLAIR Endovascular Stent Graft\n\nFLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft'}, {'id': 'OG001', 'title': 'PTA Only', 'description': 'Percutaneous Transluminal Angioplasty\n\nPTA: Treatment of stenoses with PTA only'}], 'classes': [{'categories': [{'measurements': [{'value': '0.518', 'groupId': 'OG000', 'lowerLimit': '0.410', 'upperLimit': '0.626'}, {'value': '0.574', 'groupId': 'OG001', 'lowerLimit': '0.481', 'upperLimit': '0.668'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Postintervention secondary patency \\[PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial\\] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Index of Patency Function (IPF) [the Average Number of Months Between Interventions] Rates of FLAIR™ and PTA at at 24 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLAIR', 'description': 'FLAIR Endovascular Stent Graft\n\nFLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft'}, {'id': 'OG001', 'title': 'PTA Only', 'description': 'Percutaneous Transluminal Angioplasty\n\nPTA: Treatment of stenoses with PTA only'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '7.04', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '5.22', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 months', 'description': 'The IPF is summarized was defined as the time from the index study procedure to complete graft abandonment divided by the number of visits for a reintervention performed on the AV access circuit in order to maintain vascular access for hemodialysis.', 'unitOfMeasure': 'Months/intervention', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who were enrolled in the study will participate in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).Blackwelder t-test testing non-inferiority of the FLAIR® group to that of PTA.'}, {'type': 'SECONDARY', 'title': 'Post-Intervention Assisted Primary Patency at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLAIR', 'description': 'FLAIR Endovascular Stent Graft\n\nFLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft'}, {'id': 'OG001', 'title': 'PTA Only', 'description': 'Percutaneous Transluminal Angioplasty\n\nPTA: Treatment of stenoses with PTA only'}], 'classes': [{'categories': [{'measurements': [{'value': '0.596', 'groupId': 'OG000', 'lowerLimit': '0.512', 'upperLimit': '0.681'}, {'value': '0.656', 'groupId': 'OG001', 'lowerLimit': '0.573', 'upperLimit': '0.740'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 month follow up', 'description': 'Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-intervention Secondary Patency at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLAIR', 'description': 'FLAIR Endovascular Stent Graft\n\nFLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft'}, {'id': 'OG001', 'title': 'PTA Only', 'description': 'Percutaneous Transluminal Angioplasty\n\nPTA: Treatment of stenoses with PTA only'}], 'classes': [{'categories': [{'measurements': [{'value': '0.748', 'groupId': 'OG000', 'lowerLimit': '0.673', 'upperLimit': '0.822'}, {'value': '0.793', 'groupId': 'OG001', 'lowerLimit': '0.722', 'upperLimit': '0.864'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 month follow-up', 'description': 'Postintervention secondary patency \\[PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial\\] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Treatment Area Primary Patency (TAPP) at 12 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLAIR', 'description': 'FLAIR Endovascular Stent Graft\n\nFLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft'}, {'id': 'OG001', 'title': 'PTA Only', 'description': 'Percutaneous Transluminal Angioplasty\n\nPTA: Treatment of stenoses with PTA only'}], 'classes': [{'categories': [{'measurements': [{'value': '0.476', 'groupId': 'OG000', 'lowerLimit': '0.389', 'upperLimit': '0.564'}, {'value': '0.248', 'groupId': 'OG001', 'lowerLimit': '0.170', 'upperLimit': '0.325'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months follow up', 'description': 'TAPP is defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5mm proximal or 5mm distal to the study device or index balloon angioplasty treated area), or thrombotic occlusion that involved the treatment area.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Treatment Area Primary Patency (TAPP) at 24 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLAIR', 'description': 'FLAIR Endovascular Stent Graft\n\nFLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft'}, {'id': 'OG001', 'title': 'PTA Only', 'description': 'Percutaneous Transluminal Angioplasty\n\nPTA: Treatment of stenoses with PTA only'}], 'classes': [{'categories': [{'measurements': [{'value': '0.269', 'groupId': 'OG000', 'lowerLimit': '0.177', 'upperLimit': '0.360'}, {'value': '0.135', 'groupId': 'OG001', 'lowerLimit': '0.068', 'upperLimit': '0.202'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months follow-up', 'description': 'TAPP is defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5mm proximal or 5mm distal to the study device or index balloon angioplasty treated area), or thrombotic occlusion that involved the treatment area.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FLAIR', 'description': 'FLAIR Endovascular Stent Graft\n\nFLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft'}, {'id': 'FG001', 'title': 'PTA Only', 'description': 'Percutaneous Transluminal Angioplasty (PTA): Treatment of stenoses with PTA only'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '132'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '94'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'Adverse Experience', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'FLAIR', 'description': 'FLAIR Endovascular Stent Graft\n\nFLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft'}, {'id': 'BG001', 'title': 'PTA Only', 'description': 'Percutaneous Transluminal Angioplasty\n\nPTA: Treatment of stenoses with PTA only'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '89'}, {'value': '63', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '88'}, {'value': '63.5', 'groupId': 'BG002', 'lowerLimit': '24', 'upperLimit': '89'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': "Subjects with hemodynamically significant stenosis fifty percent, clinical evidence of graft dysfunction (without thrombotic occlusion) at the synthetic AV access graft anastomosis, and who were selected from the Investigator's general subject population were eligible for participation in this study."}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2008-05-12', 'resultsFirstSubmitDate': '2014-01-20', 'studyFirstSubmitQcDate': '2008-05-13', 'lastUpdatePostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-08-06', 'studyFirstPostDateStruct': {'date': '2008-05-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ACPP Was Defined as the Interval Following the Index Procedure Until the Next Access Thrombosis or Reintervention.', 'timeFrame': '12 months', 'description': 'To demonstrate that the post intervention Access Circuit Primary Patency (ACPP) of FLAIR™ is superior to that of PTA at 12 months post study procedure.'}, {'measure': 'The Index of Patency Function (IPF) [the Average Number of Months Between Interventions] of FLAIR™ is Not Inferior to That of PTA at 12 Months Post Study Procedure.', 'timeFrame': '12 months', 'description': 'The IPF is summarized was defined as the time from the index study procedure to complete graft abandonment divided by the number of visits for a reintervention performed on the arteriovenous (AV) access circuit in order to maintain vascular access for hemodialysis.'}, {'measure': 'The Number of Participants With Device and/or Procedure Related Adverse Events at 12 Months Post Study Procedure.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'To Assess the Number of Re-interventions to the Access Circuit Until Graft Abandonment or Through 12 Months Post-index Procedure', 'timeFrame': 'Patient Follow-Up', 'description': 'The estimated number of re-interventions to the access circuit until graft abandonment or through 12 months post-index procedure was a secondary endpoint without hypothesis testing and is therefore summarized descriptively.'}, {'measure': 'Post-Intervention Assisted Primary Patency at 12 Months', 'timeFrame': '12 months', 'description': 'Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.'}, {'measure': 'Post-intervention Secondary Patency (PSP) at 12 Months', 'timeFrame': '12 months', 'description': 'Postintervention secondary patency \\[PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial\\] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.'}, {'measure': 'Procedural Success', 'timeFrame': 'Patient Follow-Up', 'description': 'Procedural success was a secondary endpoint without hypothesis testing and is therefore summarized descriptively. Procedural success is defined as anatomic success and at least one indicator of hemodynamic or clinical success.'}, {'measure': 'Analysis of Proportion of Serious Adverse Events Classified as Device and/or Procedure-Related Through 30 Days Post-Procedure', 'timeFrame': 'Patient Follow-Up', 'description': 'The incidence of device-related and procedure-related serious adverse events (SAEs) from the index procedure through 30 days post procedure is summarized. The purpose of this analysis was to assess the effectiveness of the Bard Peripheral Vascular (BPV) clinician training program.'}, {'measure': 'Demonstrate Non-inferiority of FLAIR Safety in Terms of Serious Adverse Events at 12 Months', 'timeFrame': '12 months', 'description': 'Serious Adverse Events at 12 months are reported for all 270 subjects.'}, {'measure': 'Access Circuit Primary Patency (ACCP) at 24 Months Procedure Until the Next Access Thrombosis or Reintervention.', 'timeFrame': '24 months', 'description': 'Access Circuit Primary Patency (ACPP) was defined as the interval following the index procedure until the next access thrombosis or reintervention at 24 months.'}, {'measure': 'To Estimate Safety at 24 Months.', 'timeFrame': '24 months', 'description': 'To estimate the percentage of participants without safety issues through 24 months.'}, {'measure': 'Post-Intervention Assisted Primary Patency at 24 Months', 'timeFrame': '24 month follow up', 'description': 'Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.'}, {'measure': 'Post-intervention Secondary Patency at 24 Months', 'timeFrame': '24 months', 'description': 'Postintervention secondary patency \\[PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial\\] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.'}, {'measure': 'Index of Patency Function (IPF) [the Average Number of Months Between Interventions] Rates of FLAIR™ and PTA at at 24 Months.', 'timeFrame': '24 months', 'description': 'The IPF is summarized was defined as the time from the index study procedure to complete graft abandonment divided by the number of visits for a reintervention performed on the AV access circuit in order to maintain vascular access for hemodialysis.'}, {'measure': 'Post-Intervention Assisted Primary Patency at 6 Months', 'timeFrame': '6 month follow up', 'description': 'Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.'}, {'measure': 'Post-intervention Secondary Patency at 6 Months', 'timeFrame': '6 month follow-up', 'description': 'Postintervention secondary patency \\[PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial\\] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hemodialysis', 'Vascular Prosthesis', 'Stenosis', 'End-stage Renal Disease (ESRD)'], 'conditions': ['Stenosis of Vascular Prosthetic Devices, Implants and Grafts']}, 'referencesModule': {'references': [{'pmid': '27388566', 'type': 'RESULT', 'citation': 'Haskal ZJ, Saad TF, Hoggard JG, Cooper RI, Lipkowitz GS, Gerges A, Ross JR, Pflederer TA, Mietling SW. Prospective, Randomized, Concurrently-Controlled Study of a Stent Graft versus Balloon Angioplasty for Treatment of Arteriovenous Access Graft Stenosis: 2-Year Results of the RENOVA Study. J Vasc Interv Radiol. 2016 Aug;27(8):1105-1114.e3. doi: 10.1016/j.jvir.2016.05.019. Epub 2016 Jul 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to confirm the long-term safety and effectiveness of the FLAIR Endovascular Stent Graft for treatment of stenoses at the venous anastomosis of ePTFE or other synthetic arteriovenous (AV) access grafts.', 'detailedDescription': 'The purpose of the study is to compare efficacy data on subjects randomized to treatment with percutaneous transluminal angioplasty (PTA) and the FLAIR™ Endovascular Stent Graft versus subjects randomized to treatment with PTA only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject must be either a male or non-pregnant female greater than or equal to 21 years of age\n* Subject is willing to comply with the protocol requirements and can be contacted by telephone\n* Subject has a synthetic AV access graft located in an arm that has been implanted for greater than or equal to 30 days and has undergone at least one successful dialysis session prior to the index procedure\n* Angiographic evidence (per the institution's standard) is available to indicate that the subject has a stenosis greater than or equal to 50% located at the graft-vein anastomosis of subject's synthetic AV access graft\n* The target lesion is estimated to be less than or equal to 7 cm in length (by angiography)\n* The entire target lesion is located within 7 cm of the graft-vein anastomosis, as verified by angiography, such that approximately 1 cm of the FLAIR™ Endovascular Stent Graft will extend into non-diseased vein and approximately 1 cm but no more than 2 cm of the FLAIR™ Endovascular Stent Graft will extend into the non-diseased AV graft\n* Full expansion of an appropriately sized angioplasty balloon, in the operator's judgment, can be achieved during primary angioplasty\n* Graft diameter at the deployment site is between 5 mm and 8 mm as verified by angiography\n\nExclusion Criteria:\n\n* The subject has a life expectancy of \\< 25 months.\n* The target lesion has had a corresponding thrombosis treated less than or equal to 7 days prior to the index procedure.\n* A previously placed stent and/or stent graft located in the treatment area is present. Treatment area includes the entire target lesion and 1 cm of landing zone into both non-diseased AV graft and non-diseased vein.\n* The subject has an infected AV access graft or uncontrolled systemic infection.\n* The presence of additional lesion(s) in the access circuit less than or equal to 3 cm from the edges of the target lesion that was treated less than or equal to 30 days prior to index procedure.\n* The presence of additional lesion(s) in the access circuit \\> 3 cm from the edges of the primary lesion that are greater than or equal to 30% stenosed. Note: Subjects may be included if the additional lesions(s) can be successfully treated with a final residual stenosis of \\< 30% prior to the index procedure.\n* The location of the target lesion would require that the FLAIR™ Endovascular Stent Graft be deployed fully across the elbow joint (radiographically identified by a combination of the humeroulnar joint and the humeroradial joint).\n* The location of the target lesion would require that the FLAIR™ Endovascular Stent Graft cross an angle (between the inflow vein and synthetic AV access graft) that is \\> 90 degrees.\n* The subject has an uncontrolled blood coagulation disorder.\n* The subject has a known allergy or sensitivity to contrast media which cannot be adequately pre-medicated.\n* The subject has a known hypersensitivity to nickel-titanium.\n* Subjects who are currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial."}, 'identificationModule': {'nctId': 'NCT00677235', 'acronym': 'RENOVA', 'briefTitle': 'Post-Approval Study for the FLAIR Endovascular Stent Graft', 'organization': {'class': 'INDUSTRY', 'fullName': 'C. R. Bard'}, 'officialTitle': 'A Prospective, Randomized, Concurrently-Controlled Post-Approval Study of the FLAIR Endovascular Stent Graft', 'orgStudyIdInfo': {'id': 'BPV-07-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FLAIR', 'description': 'FLAIR Endovascular Stent Graft', 'interventionNames': ['Device: FLAIR Endovascular Stent Graft']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PTA Only', 'description': 'Percutaneous Transluminal Angioplasty', 'interventionNames': ['Procedure: PTA']}], 'interventions': [{'name': 'FLAIR Endovascular Stent Graft', 'type': 'DEVICE', 'description': 'Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft', 'armGroupLabels': ['FLAIR']}, {'name': 'PTA', 'type': 'PROCEDURE', 'description': 'Treatment of stenoses with PTA only', 'armGroupLabels': ['PTA Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29003', 'city': 'Bamberg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Access Connections', 'geoPoint': {'lat': 33.2971, 'lon': -81.03482}}], 'overallOfficials': [{'name': 'Ziv Haskal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'C. R. Bard', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}