Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-03-01 @ 11:27 AM
Study NCT ID:
NCT02682420
Status:
TERMINATED
Last Update Posted:
2025-12-11
First Post:
2016-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
everlinQ endoAVF Post Market Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'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'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'courtney.rothwell@bd.com', 'phone': '602-830-5544', 'title': 'Courtney Rothwell, Clinical Project Manager', 'organization': 'BD Peripheral Intervention'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study was discontinued prior completion due to company acquisition. Therefore, the full analysis was completed at the 6-month time point for all remaining participants.\n\nData collection and data management was completed by a third party contractor independent of the sponsor. Statistical analysis was completed per protocol by an independent statistician.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were reported from index procedure through the study follow-up period. Data is reported through 6 months.', 'eventGroups': [{'id': 'EG000', 'title': 'endoAVF', 'description': 'everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 7, 'seriousNumAtRisk': 100, 'deathsNumAffected': 3, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising/Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Compartment Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Closure Device Embolization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants With Primary Patency of the endoAVF at 6 Months Post-Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'endoAVF', 'description': 'everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. RF energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.'}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'endoAVF creation through 6 months', 'description': 'Primary patency was defined in this study as "The interval from the time of access placement until any intervention designed to maintain or re-establish patency, access thrombosis, access abandonment, or the time of measurement of patency".', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Participants With Assisted Primary Patency of the endoAVF at 6 Months Post-Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'endoAVF', 'description': 'everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'endoAVF creation through 6 Months', 'description': 'Assisted Primary Patency was defined in this study as "The interval from access placement to thrombosis or abandonment; not triggered by access circuit interventions performed in the absence of occlusion".', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Participants With Secondary Patency of the endoAVF at 6 Months Post-Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'endoAVF', 'description': 'everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.'}], 'classes': [{'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'endoAVF creation through 6 Months', 'description': 'Secondary Patency in this study was defined as "The interval from the time of access placement until access abandonment, loss to thrombosis, or the time of patency measurement including intervening manipulations (surgical or endovascular interventions) designed to re-establish functionality in thrombosed access".', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Participants With Functional Patency of the endoAVF at 6 Months Post-Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'endoAVF', 'description': 'everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.'}], 'classes': [{'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'endoAVF creation through 6 Months', 'description': 'Functional Patency in this study was defined as "The interval of time from the first 2-needle dialysis utilizing the access until access abandonment".', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Days Post-Index Procedure for Participants to Achieve Successful Cannulation of the endoAVF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'endoAVF', 'description': 'everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000', 'lowerLimit': '60', 'upperLimit': '139'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'endoAVF creation to cannulation', 'description': 'The time (number of days) from the index procedure (successful endoAVF creation) to the first use of the endoAVF. This endpoint is evaluated per participant rather than at specific time points.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants remaining in the study that were on dialysis can be counted for this endpoint.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Procedural Success at the Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'endoAVF', 'description': 'everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'endoAVF creation', 'description': 'The successful creation of an endoAVF with blood flow confirmed intraoperatively by fistulography or by duplex ultrasound postoperatively. This outcome measure is assessed at the time of the endoAVF creation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Interventions Occurring During the Index Procedure (Adjunctive Procedures)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'endoAVF', 'description': 'everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.'}], 'classes': [{'title': 'Therapeutic Coil Embolization', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'Balloon Angioplasty', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Stent', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Thrombectomy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Thrombolytic Therapy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Transposition', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Creation of Surgical AVF/Graft', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Participants with ≥1 Adjunctive Procedures', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'endoAVF creation', 'description': 'The endoAVF-related interventions include:\n\n* Interventions to maintain or restore patency of the endoAVF, including endovascular and surgical procedures designed to address occlusive thrombosis (resulting in absence of thrill or bruit at endoAVF) and clinically significant occlusive stenosis at or near endoAVF site.\n* Interventions to support maturation of the arterialized vein segments, including endovascular procedures such as secondary coil embolization to facilitate flow into the target cannulation veins.\n* Interventions to support cannulation of the arterialized vein segments, including procedures such as a superficialization or elevation where the target cannulation vein is brought closer to the skin surface to enable cannulation, without the creation of a new AV fistula.\n* Any intervention to address any complications or adverse events of the access circuit.\n\nThis outcome measure is assessed at the time of the endoAVF creation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Interventions Occurring After the Index Procedure (Reinterventions)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'endoAVF', 'description': 'everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.'}], 'classes': [{'title': 'Total Maturation and Maintenance Interventions', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Subjects with ≥1 Reintervention', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Total Maturation Interventions', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Superficialization (Maturation)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Coiling (Maturation)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Total Maintenance Interventions', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'PTA (Maintenance)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Stent Placement (Maintenance)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Thrombolysis (Maintenance)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'endoAVF creation through 6 Months', 'description': 'The endoAVF-related interventions include:\n\n* Interventions to maintain or restore patency of the endoAVF, including endovascular and surgical procedures designed to address occlusive thrombosis (resulting in absence of thrill or bruit at endoAVF) and clinically significant occlusive stenosis at or near endoAVF site.\n* Interventions to support maturation of the arterialized vein segments, including endovascular procedures such as secondary coil embolization to facilitate flow into the target cannulation veins.\n* Interventions to support cannulation of the arterialized vein segments, including procedures such as a superficialization or elevation where the target cannulation vein is brought closer to the skin surface to enable cannulation, without the creation of a new AV fistula.\n* Any intervention to address any complications or adverse events of the access circuit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Participants in Which endoAVF Maturation Was Achieved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'At 1 Month', 'description': 'Participants that have met the definition for maturity by the 1 Month follow-up visit'}, {'id': 'OG001', 'title': 'At 3 Months', 'description': 'Participants that have met the definition for maturity by the 3 Month follow-up visit'}, {'id': 'OG002', 'title': 'At 6 Months', 'description': 'Participants that have met the definition for maturity by the 6 Month follow-up visit'}, {'id': 'OG003', 'title': 'At Any Visit', 'description': 'Participants that have met the definition for maturity at any visit'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'endoAVF creation through 6 months', 'description': 'Total time from successful endoAVF creation to one of the following:\n\n* Successful hemodialysis using 2 needle cannulation OR\n* Vascular access that is free of stenosis or thrombosis, with brachial artery flow of at least 500 ml/min and at least a 4.0 mm vein diameter as measured via duplex ultrasound.\n\nNote: 63 participants completed the 6-month visit. Participants who did not receive a duplex ultrasound and have not yet successfully dialyzed using 2 needle cannulation are not counted for this endpoint.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants That Were Not on Dialysis at endoAVF Creation and Are Central Venous Catheter (CVC) Free at Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'At 1 Month', 'description': 'Participants that were not on dialysis at the time of endoAVF creation and were catheter-free at 30 days of follow-up'}, {'id': 'OG001', 'title': 'At 6 Months', 'description': 'Participants that were not on dialysis at the time of endoAVF creation and were catheter-free at 180 days of follow-up'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'endoAVF creation through 6 Months', 'description': 'Number of participants that were not on dialysis at endoAVF creation and are central venous catheter (CVC) free at indicated time points.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants That Experienced Device-related Serious Adverse Events Through 6 Months Post-Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'endoAVF', 'description': 'everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'endoAVF creation through 6 Months', 'description': 'AE that:\n\n* led to death,\n* led to serious deterioration in the health of the patient, that either resulted in: a life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,\n* led to fetal distress, fetal death or a congenital abnormality or birth defect And has been determined by the CEC to be related to the everlinQ endoAVF System', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants That Experienced Procedure-related Serious Adverse Events Through 6 Months Post-Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'endoAVF', 'description': 'everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'endoAVF creation through 6 Months', 'description': 'AE that:\n\n* led to death,\n* led to serious deterioration in the health of the patient, that either resulted in: a life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,\n* led to fetal distress, fetal death or a congenital abnormality or birth defect And has been determined by the CEC to be related to the index procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Dialysis Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'endoAVF', 'description': 'everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.'}], 'classes': [{'title': 'On Dialysis at Enrollment', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'Began Dialysis During Study', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Not on Dialysis Through End of Study', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'endoAVF creation through 6 months', 'description': "This outcome measure references the participant's dialysis status throughout the study. Participants who began dialysis during the study and participants who were not on dialysis through the end of the study were not on dialysis at baseline.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'endoAVF', 'description': 'everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Note: 63 participants completed the 6-month visit. The study was discontinued prematurely due to company acquisition and therefore, many participants did not complete their 12-month visit.', 'groupId': 'FG000', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}]}], 'recruitmentDetails': 'The everlinQ endoAVF Post Market Study began enrollment on September 20th 2016 and the last patient was enrolled on January 17th 2019.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'endoAVF', 'description': 'everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. RF energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.6', 'spread': '16.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '100', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '70', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '28.4', 'spread': '7.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'EndoAVF Device', 'classes': [{'categories': [{'title': '4 French', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}, {'title': '6 French', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "This baseline measure describes the everlinQ endoAVF device selected by the physician for the participant's index procedure. Two different size devices were used within this study: the 4 French version and the 6 French version.", 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-06', 'size': 1049647, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-18T16:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'whyStopped': 'Company acquisition', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2016-02-05', 'resultsFirstSubmitDate': '2021-08-25', 'studyFirstSubmitQcDate': '2016-02-12', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2021-11-15', 'studyFirstPostDateStruct': {'date': '2016-02-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Participants With Assisted Primary Patency of the endoAVF at 6 Months Post-Index Procedure', 'timeFrame': 'endoAVF creation through 6 Months', 'description': 'Assisted Primary Patency was defined in this study as "The interval from access placement to thrombosis or abandonment; not triggered by access circuit interventions performed in the absence of occlusion".'}, {'measure': 'Participants With Secondary Patency of the endoAVF at 6 Months Post-Index Procedure', 'timeFrame': 'endoAVF creation through 6 Months', 'description': 'Secondary Patency in this study was defined as "The interval from the time of access placement until access abandonment, loss to thrombosis, or the time of patency measurement including intervening manipulations (surgical or endovascular interventions) designed to re-establish functionality in thrombosed access".'}, {'measure': 'Participants With Functional Patency of the endoAVF at 6 Months Post-Index Procedure', 'timeFrame': 'endoAVF creation through 6 Months', 'description': 'Functional Patency in this study was defined as "The interval of time from the first 2-needle dialysis utilizing the access until access abandonment".'}, {'measure': 'Number of Days Post-Index Procedure for Participants to Achieve Successful Cannulation of the endoAVF', 'timeFrame': 'endoAVF creation to cannulation', 'description': 'The time (number of days) from the index procedure (successful endoAVF creation) to the first use of the endoAVF. This endpoint is evaluated per participant rather than at specific time points.'}, {'measure': 'Number of Participants With Procedural Success at the Index Procedure', 'timeFrame': 'endoAVF creation', 'description': 'The successful creation of an endoAVF with blood flow confirmed intraoperatively by fistulography or by duplex ultrasound postoperatively. This outcome measure is assessed at the time of the endoAVF creation.'}, {'measure': 'Number of Participants With Interventions Occurring During the Index Procedure (Adjunctive Procedures)', 'timeFrame': 'endoAVF creation', 'description': 'The endoAVF-related interventions include:\n\n* Interventions to maintain or restore patency of the endoAVF, including endovascular and surgical procedures designed to address occlusive thrombosis (resulting in absence of thrill or bruit at endoAVF) and clinically significant occlusive stenosis at or near endoAVF site.\n* Interventions to support maturation of the arterialized vein segments, including endovascular procedures such as secondary coil embolization to facilitate flow into the target cannulation veins.\n* Interventions to support cannulation of the arterialized vein segments, including procedures such as a superficialization or elevation where the target cannulation vein is brought closer to the skin surface to enable cannulation, without the creation of a new AV fistula.\n* Any intervention to address any complications or adverse events of the access circuit.\n\nThis outcome measure is assessed at the time of the endoAVF creation.'}, {'measure': 'Number of Participants With Interventions Occurring After the Index Procedure (Reinterventions)', 'timeFrame': 'endoAVF creation through 6 Months', 'description': 'The endoAVF-related interventions include:\n\n* Interventions to maintain or restore patency of the endoAVF, including endovascular and surgical procedures designed to address occlusive thrombosis (resulting in absence of thrill or bruit at endoAVF) and clinically significant occlusive stenosis at or near endoAVF site.\n* Interventions to support maturation of the arterialized vein segments, including endovascular procedures such as secondary coil embolization to facilitate flow into the target cannulation veins.\n* Interventions to support cannulation of the arterialized vein segments, including procedures such as a superficialization or elevation where the target cannulation vein is brought closer to the skin surface to enable cannulation, without the creation of a new AV fistula.\n* Any intervention to address any complications or adverse events of the access circuit.'}, {'measure': 'Participants in Which endoAVF Maturation Was Achieved', 'timeFrame': 'endoAVF creation through 6 months', 'description': 'Total time from successful endoAVF creation to one of the following:\n\n* Successful hemodialysis using 2 needle cannulation OR\n* Vascular access that is free of stenosis or thrombosis, with brachial artery flow of at least 500 ml/min and at least a 4.0 mm vein diameter as measured via duplex ultrasound.\n\nNote: 63 participants completed the 6-month visit. Participants who did not receive a duplex ultrasound and have not yet successfully dialyzed using 2 needle cannulation are not counted for this endpoint.'}, {'measure': 'Number of Participants That Were Not on Dialysis at endoAVF Creation and Are Central Venous Catheter (CVC) Free at Indicated Time Points', 'timeFrame': 'endoAVF creation through 6 Months', 'description': 'Number of participants that were not on dialysis at endoAVF creation and are central venous catheter (CVC) free at indicated time points.'}, {'measure': 'Number of Participants That Experienced Device-related Serious Adverse Events Through 6 Months Post-Index Procedure', 'timeFrame': 'endoAVF creation through 6 Months', 'description': 'AE that:\n\n* led to death,\n* led to serious deterioration in the health of the patient, that either resulted in: a life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,\n* led to fetal distress, fetal death or a congenital abnormality or birth defect And has been determined by the CEC to be related to the everlinQ endoAVF System'}, {'measure': 'Number of Participants That Experienced Procedure-related Serious Adverse Events Through 6 Months Post-Index Procedure', 'timeFrame': 'endoAVF creation through 6 Months', 'description': 'AE that:\n\n* led to death,\n* led to serious deterioration in the health of the patient, that either resulted in: a life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,\n* led to fetal distress, fetal death or a congenital abnormality or birth defect And has been determined by the CEC to be related to the index procedure'}], 'primaryOutcomes': [{'measure': 'Participants With Primary Patency of the endoAVF at 6 Months Post-Index Procedure', 'timeFrame': 'endoAVF creation through 6 months', 'description': 'Primary patency was defined in this study as "The interval from the time of access placement until any intervention designed to maintain or re-establish patency, access thrombosis, access abandonment, or the time of measurement of patency".'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'Prospective, multi-center study to evaluate the everlinQ endoAVF System when used to create an endovascular arteriovenous fistula (endoAVF) for patients who require vascular access for hemodialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (age \\>18 years old)\n* Currently on chronic dialysis or expected to be started on chronic dialysis within 3 months of planned endoAVF creation\n* Target treatment vein diameter(s) for fistula creation ≥ 2.0 mm as measured via Duplex Ultrasound or Venogram\n* Target treatment artery diameter(s) for fistula creation ≥ 2.0 mm as measured via Duplex Ultrasound or Arteriogram\n* Both radial and ulnar artery flow to the hand, as confirmed with Duplex Ultrasound and/or Allen\'s test (i.e.: palmar arch)\n\nExclusion Criteria:\n\n* Known central venous stenosis or central vein narrowing \\> 50% based on imaging on the same side as the planned AVF creation\n* Absence of perforator feeding the target cannulation vein(s) via Venogram\n* Occlusion or stenosis \\>50% of target cannulation cephalic or basilic vein\n* Significantly compromised (≥50% stenosis) flow in the treatment arm\n* Documented ejection fraction (EF) ≤35% in the last 6 months\n* Pregnant women\n* New York Heart Association (NYHA) class III or IV heart failure\n* Hypercoagulable state\n* Known bleeding diathesis\n* Documented history of drug abuse including intravenous drugs within six months of AVF creation\n* "Planned" concomitant major surgical procedure within 6 months of enrollment or previous major surgery within 30 days of enrollment\n* Known allergy to contrast dye which cannot be adequately pre-medicated\n* Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated\n* Evidence of active infections on the day of the index procedure\n* Estimated life expectancy \\< 1 year\n* Patient is not willing to provide written informed consent, is not geographically stable and/or not willing to comply with required follow-up\n* Patient with a target cannulation vein that is \\> 6mm deep that would require a transposition procedure, defined as the elevation of a target cannulation vein AND the creation of a new AV fistula\n* Patient is not willing to undergo a 2nd stage procedure as defined in Section 4.5.3 of the study protocol.'}, 'identificationModule': {'nctId': 'NCT02682420', 'briefTitle': 'everlinQ endoAVF Post Market Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'C. R. Bard'}, 'officialTitle': 'everlinQ endoAVF Post Market Study', 'orgStudyIdInfo': {'id': 'CD-0018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'endoAVF', 'interventionNames': ['Device: everlinQ endoAVF System']}], 'interventions': [{'name': 'everlinQ endoAVF System', 'type': 'DEVICE', 'armGroupLabels': ['endoAVF']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6Z 2K5', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Providence Health Care Society', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'University Hospital Carl Gustav Carus', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Dominikus Hospital', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'University of Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'University of Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Mannheim', 'country': 'Germany', 'facility': 'University of Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'city': 'Münster', 'country': 'Germany', 'facility': 'St. Franziskus-Hospital Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': 'OX3 9DU', 'city': 'Headington', 'state': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford University Hospitals - NHS Foundation Trust', 'geoPoint': {'lat': 51.75737, 'lon': -1.21974}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'University Hospitals Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "St. George's University", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester University NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Nicholas Inston, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Birmingham NHS'}, {'name': 'Thomas Schmitz-Rixen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univerisity of Frankfurt, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'C. R. Bard', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}