Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-02-27 @ 6:19 PM
Study NCT ID:
NCT02730234
Status:
COMPLETED
Last Update Posted:
2021-08-11
First Post:
2016-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
JetStream Atherectomy for the Treatment of In-stent Restenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000800', 'term': 'Angioplasty, Balloon'}], 'ancestors': [{'id': 'D017130', 'term': 'Angioplasty'}, {'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shammasg@mcrfmd.com', 'phone': '5633242828', 'title': 'Nicolas W Shammas', 'phoneExt': '102', 'organization': 'Midwest Cardiovascular Research Foundation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The built in aspiration system may reduce potential debris, although it does not eliminate this problem completely. Lack of safety data in class III and IV stent fractures and the safety of the device in tortuous vessels (\\>45 degrees) has not been demonstrated given wire bias in these vessels.'}}, 'adverseEventsModule': {'timeFrame': 'Major Adverse Events were collected for up to 1 year', 'description': 'Definition are consistent with clinicaltrials.gov definition for AE and SAE', 'eventGroups': [{'id': 'EG000', 'title': 'JetStream XC With Balloon Angioplasty', 'description': 'The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.\n\nJetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 15, 'seriousNumAtRisk': 60, 'deathsNumAffected': 8, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Angina', 'notes': 'Chest pain due to ischemic heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 60, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'worsening claudication in non affected limb', 'notes': 'worsening claudication and interventions on the non affected limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 60, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Target Lesion Revascularization with Bailout Stenting', 'notes': 'Retreatment of the index lesion (extended 1 cm proximal and distal to the lesion). At 1 Year.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Target Lesion Revascularization without Bailout Stenting', 'notes': 'at 1 year', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Unplanned Major amputation', 'notes': 'at 1 month', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'New Stent Fracture or Disruption', 'notes': 'at 1 month', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Device Induced Vascular Injury', 'notes': 'at 1 month', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Distal Embolization', 'notes': 'at 1 month', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Major Bleeding', 'notes': 'at 1 month', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nonfatal myocardial Infarction', 'notes': 'at 1 month', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Target Lesion Revascularization (TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JetStream XC With Balloon Angioplasty', 'description': 'The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.\n\nJetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 6 months. For the primary endpoint, intra-procedural bail out stenting of the index lesion is considered meeting a TLR endpoint. (ITT analysis)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '5 people died at 6 months. 1 patient had TLR before death and was counted in the TLR analysis. 4 patients were not analyzed at 6 months as they were dead before a TLR occurred (censored). So these 4 patients were excluded from the analysis at 6 months.'}, {'type': 'PRIMARY', 'title': 'Major Adverse Events (MAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JetStream XC With Balloon Angioplasty', 'description': 'The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.\n\nJetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'unplanned major amputation, all cause mortality, and Bailout Stenting consider Target Lesion Revascularization (TLR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients were analyzed.'}, {'type': 'SECONDARY', 'title': 'Device Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JetStream XC With Balloon Angioplasty', 'description': 'The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.\n\nJetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraprocedural', 'description': 'Categorized by \\< 50% residual stenosis following JS atherectomy alone and without additional adjunctive PTA or bail out procedures as determined by the Angiographic Core Laboratory.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '15 patients did not have interpretable angiographic films by core lab'}, {'type': 'SECONDARY', 'title': 'Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JetStream XC With Balloon Angioplasty', 'description': 'The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.\n\nJetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraprocedural', 'description': 'Defined as ≤30% residual diameter stenosis following JS + PTA without provisional or bailout procedures', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '11 patients with angiogram not interpretable by core lab'}, {'type': 'SECONDARY', 'title': 'Target Lesion Revascularization (TLR) With no Bailout Stent Included', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JetStream XC With Balloon Angioplasty', 'description': 'The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.\n\nJetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 6 months. Intra-procedural bail out stenting of the index lesion is NOT considered meeting a TLR endpoint. (ITT analysis)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '5 patients died after hospital discharge out of 60 patients'}, {'type': 'SECONDARY', 'title': 'Target Lesion Revascularization (TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JetStream XC With Balloon Angioplasty', 'description': 'The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.\n\nJetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 1 year ITT (bail out stent in the Lab is not considered as TLR)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '8 patients died at 1 year before TLR occurred and so censored out.'}, {'type': 'SECONDARY', 'title': 'Clinical Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JetStream XC With Balloon Angioplasty', 'description': 'The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.\n\nJetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Defined as PSVR ≤ 2.5 at the treated site or \\< 50% stenosis by angiography as determined by the Angiographic Core Laboratory in the absence of TLR, amputation, and/or surgical bypass (the evaluation of patency is extended to one cm proximal and one cm distal to the target lesion)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '20 patients either died or had no duplex US at 6 month to assess patency'}, {'type': 'SECONDARY', 'title': 'Clinical Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JetStream XC With Balloon Angioplasty', 'description': 'The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.\n\nJetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Defined as PSVR ≤ 2.5 at the treated site or \\< 50% stenosis by angiography as determined by the Angiographic Core Laboratory in the absence of TLR, amputation, and/or surgical bypass (the evaluation of patency is extended to one cm proximal and one cm distal to the target lesion)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '41 patients either died or did not have a Duplex Ultrasound to assess for patency at 1 year'}, {'type': 'SECONDARY', 'title': 'Change in Walking Impairment Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JetStream XC With Balloon Angioplasty', 'description': 'The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.\n\nJetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.8', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '34.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Defined as the change in mean Walking Impairment Questionnaire (WIQ) score at 6 months minus baseline. WIQ score range is 0 to 56. A higher score means a better outcome. WIQ is reported as a change between baseline and 6 months in the score (WIQ score at 6 months minus WIQ score at baseline)', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not available on 12 patients that either died or test not performed'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Rutherford Clinical Category Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JetStream XC With Balloon Angioplasty', 'description': 'The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.\n\nJetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Defined as the change in clinical status indicated by the number of participants that had one improvement of their Rutherford Becker category by at least 1 category at 6 months. The Rutherford category is done on a scale of 0 (no symptoms) to 6 (gangrene/ulceration). A change downward from one category to another is considered an improvement.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '38/49 77.5% participants showed improvment by at least 1 category at 6 months'}, {'type': 'SECONDARY', 'title': 'Change in Ankle-Brachial Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JetStream XC With Balloon Angioplasty', 'description': 'The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.\n\nJetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Defined as the mean ankle-brachial index (ABI) at 6 months minus mean ABI at baseline in subjects with compressible arteries and baseline ABI \\< 0.9 (0 to 1.2 is the scale ranging from severe disease to normal respectively; higher is better).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The change in ABI at 6 months is a mean of 0.2+/- 0.3.'}, {'type': 'SECONDARY', 'title': 'Change in Walking Impairment Questionnaire at 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JetStream XC With Balloon Angioplasty', 'description': 'The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.\n\nJetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.7', 'spread': '10.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Year', 'description': 'Defined as the change in mean Walking Impairment Questionnaire (Score 0 to 56. A higher score means a better outcome) from Baseline minus at one Year.\n\n29.2-48.8 is the confidence interval minimum and maximum values.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '38.7 % improvement from baseline to 1 year.'}, {'type': 'SECONDARY', 'title': 'Rutherford Clinical Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JetStream XC With Balloon Angioplasty', 'description': 'The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.\n\nJetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 Year', 'description': 'Defined as the change in clinical status indicated by the change in Rutherford Becker Class at 1 Year compared to baseline by at least one category that is attributable to the treated limb (in cases of bilateral disease).\n\nCategories are 0 which is asymptomatic to 6 which is gangrene. (Rutherford Becker Category:0=Asymptomatic, 1 = Mild Claudication, 2=moderated claudication, 3= severe claudication, 4= resting pain, 5= ulcers, 6= ulcers with gangrene.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '17 patients either died or Rutherford Category was not assessed due to no office visit or not evaluated.'}, {'type': 'SECONDARY', 'title': 'Ankle Brachial Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JetStream XC With Balloon Angioplasty', 'description': 'The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.\n\nJetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '0.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Year', 'description': 'Defined as the change in mean ankle-brachial index (ABI) at 1 Year minus mean ABI at baseline in subjects with compressible arteries and baseline ABI \\< 0.9. Units on a Scale: 0 to 1.2 (worse to normal respectively)', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '29 patients missing because of death or ABI not obtained at visit or visit did not occur'}, {'type': 'SECONDARY', 'title': 'Clinically Driven Target Lesion Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JetStream XC With Balloon Angioplasty', 'description': 'The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.\n\nJetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Clinically-driven TLR (CD-TLR) at 6 months was defined as any reintervention or bypass graft surgery involving a target lesion with a ≥70% diameter stenosis by angiography or PSVR \\>3.5 and at least 2 of the following associated events: ≥1-level worsening of the Rutherford category, worsening WIQ score by ≥20 points, or an ABI drop \\>0.15 between baseline and follow-up.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '8/45 experienced CD TLR (by KM)'}, {'type': 'SECONDARY', 'title': 'Clinically Driven Target Lesion Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JetStream XC With Balloon Angioplasty', 'description': 'The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.\n\nJetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Clinically-driven TLR (CD-TLR) was defined as any reintervention or bypass graft surgery involving a target lesion with a ≥70% diameter stenosis by angiography or PSVR \\>3.5 and at least 2 of the following associated events: ≥1-level worsening of the Rutherford category, worsening WIQ score by ≥20 points, or an ABI drop \\>0.15 between baseline and follow-up.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '11/32 experienced CD-TLR at 1 year'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'JetStream XC With Balloon Angioplasty', 'description': 'The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.\n\nJetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '8 Deaths', 'groupId': 'FG000', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'JetStream XC With Balloon Angioplasty', 'description': 'The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.\n\nJetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.2', 'groupId': 'BG000', 'lowerLimit': '49', 'upperLimit': '96'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'white', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '28.4', 'spread': '6.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-29', 'size': 1484078, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-03T19:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-25', 'studyFirstSubmitDate': '2016-03-25', 'resultsFirstSubmitDate': '2020-10-03', 'studyFirstSubmitQcDate': '2016-04-05', 'lastUpdatePostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-09', 'studyFirstPostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Target Lesion Revascularization (TLR)', 'timeFrame': '6 months', 'description': 'TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 6 months. For the primary endpoint, intra-procedural bail out stenting of the index lesion is considered meeting a TLR endpoint. (ITT analysis)'}, {'measure': 'Major Adverse Events (MAE)', 'timeFrame': '30 days', 'description': 'unplanned major amputation, all cause mortality, and Bailout Stenting consider Target Lesion Revascularization (TLR).'}], 'secondaryOutcomes': [{'measure': 'Device Outcome', 'timeFrame': 'Intraprocedural', 'description': 'Categorized by \\< 50% residual stenosis following JS atherectomy alone and without additional adjunctive PTA or bail out procedures as determined by the Angiographic Core Laboratory.'}, {'measure': 'Procedural Success', 'timeFrame': 'Intraprocedural', 'description': 'Defined as ≤30% residual diameter stenosis following JS + PTA without provisional or bailout procedures'}, {'measure': 'Target Lesion Revascularization (TLR) With no Bailout Stent Included', 'timeFrame': '6 months', 'description': 'TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 6 months. Intra-procedural bail out stenting of the index lesion is NOT considered meeting a TLR endpoint. (ITT analysis)'}, {'measure': 'Target Lesion Revascularization (TLR)', 'timeFrame': '1 year', 'description': 'TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 1 year ITT (bail out stent in the Lab is not considered as TLR)'}, {'measure': 'Clinical Patency', 'timeFrame': '6 months', 'description': 'Defined as PSVR ≤ 2.5 at the treated site or \\< 50% stenosis by angiography as determined by the Angiographic Core Laboratory in the absence of TLR, amputation, and/or surgical bypass (the evaluation of patency is extended to one cm proximal and one cm distal to the target lesion)'}, {'measure': 'Clinical Patency', 'timeFrame': '1 year', 'description': 'Defined as PSVR ≤ 2.5 at the treated site or \\< 50% stenosis by angiography as determined by the Angiographic Core Laboratory in the absence of TLR, amputation, and/or surgical bypass (the evaluation of patency is extended to one cm proximal and one cm distal to the target lesion)'}, {'measure': 'Change in Walking Impairment Questionnaire Score', 'timeFrame': 'Baseline and 6 months', 'description': 'Defined as the change in mean Walking Impairment Questionnaire (WIQ) score at 6 months minus baseline. WIQ score range is 0 to 56. A higher score means a better outcome. WIQ is reported as a change between baseline and 6 months in the score (WIQ score at 6 months minus WIQ score at baseline)'}, {'measure': 'Number of Participants With Rutherford Clinical Category Improvement', 'timeFrame': '6 months', 'description': 'Defined as the change in clinical status indicated by the number of participants that had one improvement of their Rutherford Becker category by at least 1 category at 6 months. The Rutherford category is done on a scale of 0 (no symptoms) to 6 (gangrene/ulceration). A change downward from one category to another is considered an improvement.'}, {'measure': 'Change in Ankle-Brachial Index', 'timeFrame': '6 months', 'description': 'Defined as the mean ankle-brachial index (ABI) at 6 months minus mean ABI at baseline in subjects with compressible arteries and baseline ABI \\< 0.9 (0 to 1.2 is the scale ranging from severe disease to normal respectively; higher is better).'}, {'measure': 'Change in Walking Impairment Questionnaire at 1 Year', 'timeFrame': '1 Year', 'description': 'Defined as the change in mean Walking Impairment Questionnaire (Score 0 to 56. A higher score means a better outcome) from Baseline minus at one Year.\n\n29.2-48.8 is the confidence interval minimum and maximum values.'}, {'measure': 'Rutherford Clinical Category', 'timeFrame': '1 Year', 'description': 'Defined as the change in clinical status indicated by the change in Rutherford Becker Class at 1 Year compared to baseline by at least one category that is attributable to the treated limb (in cases of bilateral disease).\n\nCategories are 0 which is asymptomatic to 6 which is gangrene. (Rutherford Becker Category:0=Asymptomatic, 1 = Mild Claudication, 2=moderated claudication, 3= severe claudication, 4= resting pain, 5= ulcers, 6= ulcers with gangrene.'}, {'measure': 'Ankle Brachial Index', 'timeFrame': '1 Year', 'description': 'Defined as the change in mean ankle-brachial index (ABI) at 1 Year minus mean ABI at baseline in subjects with compressible arteries and baseline ABI \\< 0.9. Units on a Scale: 0 to 1.2 (worse to normal respectively)'}, {'measure': 'Clinically Driven Target Lesion Revascularization', 'timeFrame': '6 months', 'description': 'Clinically-driven TLR (CD-TLR) at 6 months was defined as any reintervention or bypass graft surgery involving a target lesion with a ≥70% diameter stenosis by angiography or PSVR \\>3.5 and at least 2 of the following associated events: ≥1-level worsening of the Rutherford category, worsening WIQ score by ≥20 points, or an ABI drop \\>0.15 between baseline and follow-up.'}, {'measure': 'Clinically Driven Target Lesion Revascularization', 'timeFrame': '12 months', 'description': 'Clinically-driven TLR (CD-TLR) was defined as any reintervention or bypass graft surgery involving a target lesion with a ≥70% diameter stenosis by angiography or PSVR \\>3.5 and at least 2 of the following associated events: ≥1-level worsening of the Rutherford category, worsening WIQ score by ≥20 points, or an ABI drop \\>0.15 between baseline and follow-up.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Femoropopliteal In-stent Restenosis']}, 'referencesModule': {'references': [{'pmid': '26109627', 'type': 'BACKGROUND', 'citation': 'Shammas NW, Aasen N, Bailey L, Budrewicz J, Farago T, Jarvis G. Two Blades-Up Runs Using the JetStream Navitus Atherectomy Device Achieve Optimal Tissue Debulking of Nonocclusive In-Stent Restenosis: Observations From a Porcine Stent/Balloon Injury Model. J Endovasc Ther. 2015 Aug;22(4):518-24. doi: 10.1177/1526602815592135. Epub 2015 Jun 24.'}, {'pmid': '26446728', 'type': 'BACKGROUND', 'citation': 'Krankenberg H, Tubler T, Ingwersen M, Schluter M, Scheinert D, Blessing E, Sixt S, Kieback A, Beschorner U, Zeller T. Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis: The Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial. Circulation. 2015 Dec 8;132(23):2230-6. doi: 10.1161/CIRCULATIONAHA.115.017364. Epub 2015 Oct 7.'}, {'pmid': '23485840', 'type': 'BACKGROUND', 'citation': 'Beschorner U, Krankenberg H, Scheinert D, Sievert H, Tubler T, Sixt S, Noory E, Rastan A, Macharzina R, Zeller T. Rotational and aspiration atherectomy for infrainguinal in-stent restenosis. Vasa. 2013 Mar;42(2):127-33. doi: 10.1024/0301-1526/a000256.'}, {'pmid': '26596178', 'type': 'BACKGROUND', 'citation': 'Shammas NW, Shammas GA, Aasen N, Jarvis G. Number of Blades-up Runs Using JetStream XC Atherectomy for Optimal Tissue Debulking in Patients with Femoropopliteal Artery In-Stent Restenosis. J Vasc Interv Radiol. 2015 Dec;26(12):1847-51. doi: 10.1016/j.jvir.2015.08.026.'}, {'pmid': '26921281', 'type': 'BACKGROUND', 'citation': 'Shammas NW, Shammas GA, Banerjee S, Popma JJ, Mohammad A, Jerin M. JetStream Rotational and Aspiration Atherectomy in Treating In-Stent Restenosis of the Femoropopliteal Arteries: Results of the JETSTREAM-ISR Feasibility Study. J Endovasc Ther. 2016 Apr;23(2):339-46. doi: 10.1177/1526602816634028. Epub 2016 Feb 26.'}, {'pmid': '25775672', 'type': 'BACKGROUND', 'citation': 'Bosiers M, Deloose K, Callaert J, Verbist J, Hendriks J, Lauwers P, Schroe H, Lansink W, Scheinert D, Schmidt A, Zeller T, Beschorner U, Noory E, Torsello G, Austermann M, Peeters P. Superiority of stent-grafts for in-stent restenosis in the superficial femoral artery: twelve-month results from a multicenter randomized trial. J Endovasc Ther. 2015 Feb;22(1):1-10. doi: 10.1177/1526602814564385.'}, {'pmid': '25499305', 'type': 'BACKGROUND', 'citation': 'Dippel EJ, Makam P, Kovach R, George JC, Patlola R, Metzger DC, Mena-Hurtado C, Beasley R, Soukas P, Colon-Hernandez PJ, Stark MA, Walker C; EXCITE ISR Investigators. Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis). JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):92-101. doi: 10.1016/j.jcin.2014.09.009. Epub 2014 Dec 10.'}, {'pmid': '26060377', 'type': 'BACKGROUND', 'citation': 'Shammas NW. JETSTREAM Atherectomy: A Review of Technique, Tips, and Tricks in Treating the Femoropopliteal Lesions. Int J Angiol. 2015 Jun;24(2):81-6. doi: 10.1055/s-0034-1390083.'}, {'pmid': '32885736', 'type': 'DERIVED', 'citation': 'Shammas NW, Petruzzi N, Henao S, Armstrong EJ, Shimshak T, Banerjee S, Latif F, Eaves B, Brothers T, Golzar J, Shammas GA, Jones-Miller S, Christensen L, Shammas WJ. JetStream Atherectomy for the Treatment of In-Stent Restenosis of the Femoropopliteal Segment: One-Year Results of the JET-ISR Study. J Endovasc Ther. 2021 Feb;28(1):107-116. doi: 10.1177/1526602820951916. Epub 2020 Sep 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the hypothesis that Jetstream atherectomy (JS) and adjunctive balloon angioplasty (PTA) (JS +PTA) improves target lesion revascularization (TLR) at 6 months follow-up when compared to historic data from PTA alone in the treatment of femoropopliteal (FP) arterial In-stent restenotic (ISR) disease.\n\nThis is a prospective, multicenter, single arm study evaluating the investigational use of Jetstream Atherectomy (JS) and adjunctive balloon angioplasty (JS +PTA) in the treatment of FP ISR lesions in subjects with claudication or limb ischemia (Rutherford clinical category (RCC) of 2-4) (lesion length ≥ 4 cm). The comparator arm is historic data from plain old balloon angioplasty derived from a Meta-analysis of the 3 published randomized trials in the field.', 'detailedDescription': 'The Boston Scientific Jetstream XC catheter is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. The JS XC System has been cleared by the Food and Drug Administration (FDA) for use in the peripheral vasculature to treat denovo and non-stent infrainguinal lesions\n\nSeveral studies have shown that stenting of the FP artery leads to higher long term patency. Bare metal stents however have not shown conclusively to reducemTLR which is in contrast to drug coated balloons (DCB) and drug coated stents (DCS). Irrespective, stenting has several disadvantages including a continued high rate of restenosis and stent fractures that is progressive with time. FP ISR occurs in more than one third of patients at 1 year and up to 49% at 2 years. Complex lesions (long, Trans-Atlantic Inter-Society Consensus II C/D lesions, total occlusions), certain demographics (female gender, diabetes mellitus), critical limb ischemia and significant stent fractures are associated with a higher rate of restenosis. Also the majority of occluded stents are restenotic-thrombotic and generally are more challenging to treat.\n\nRecently 3 randomized trials were presented in treating FP ISR; the EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis (EXCITE ISR) trial (randomized laser + PTA vs PTA alone), the RELINE trial (Propaten Bioactive Surface vs. standard balloon angioplasty for treatment of in-stent restenosis in the superficial femoral artery) and the Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial. All these studies showed superiority over PTA in treating FP ISR. Early animal data (porcine model of FP ISR) and feasibility human data (JetStream ISR study) have shown that the JetStream device is effective in ablating restenotic tissue within restenotic FP stents and had no safety concerns within well apposed stents and in the absence of Class III and IV fractures.\n\nThe purpose of this study is to assess and estimate the effect of treating FP ISR with plaque excision using JS in combination with adjunctive PTA and compare this to historic control of PTA. The comparator arm is historic data from PTA derived from a study-level meta-analysis of the 3 published randomized trials in the field.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with symptomatic peripheral arterial disease (Rutherford Becker Class II to IV)\n2. Previously treated with stenting in the femoropopliteal segment\n3. No limit on how many times the target in-stent restenotic lesion has been previously treated.\n4. There is no exclusion based on how the prior treatment was done including if drug eluting balloons or stents have been used. Covered stents cannot be included\n5. There is no limit on the length of the target lesion as long as only one target lesion is treated and enrolled\n\nExclusion Criteria:\n\nSubjects must meet all of the following criteria to be eligible to participate in this study:\n\n1. Subject is 18 years of age or older.\n2. Subject presents with clinical evidence of peripheral arterial disease with ISR in the femoropopliteal segment (includes common femoral, superficial femoral and popliteal)\n3. Subject presents with a Rutherford Classification of 2-4 and has symptoms of rest limb pain or claudication.\n4. Target lesion(s) must be viewed angiographically and have ≥50% stenosis.\n5. The atherectomy wire must be placed entirely across all lesions to be treated with no visible evidence of clear or suspected subintimal/substent wire passage.\n6. The main target vessel reference diameter must be \\> or = 5 mm and ≤ 7 mm\n7. One patent distal run-off vessel with \\<70% disease and with brisk flow is required.\n8. Intraluminal crossing of the lesion. If this is not certain, IVUS may be used to verify this per operator's discretion\n9. Patient has signed approved informed consent.\n10. Patient is willing to comply with the follow-up evaluations at specified times."}, 'identificationModule': {'nctId': 'NCT02730234', 'acronym': 'JET-ISR', 'briefTitle': 'JetStream Atherectomy for the Treatment of In-stent Restenosis', 'organization': {'class': 'OTHER', 'fullName': 'Midwest Cardiovascular Research Foundation'}, 'officialTitle': 'JetStream Atherectomy for the Treatment of In-stent Restenosis of the Femoropopliteal Artery', 'orgStudyIdInfo': {'id': 'MCRF-S-002-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JetStream XC with balloon angioplasty', 'description': 'The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients.', 'interventionNames': ['Device: JetStream XC with balloon angioplasty']}], 'interventions': [{'name': 'JetStream XC with balloon angioplasty', 'type': 'DEVICE', 'otherNames': ['JetStream Navitus'], 'description': 'JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.', 'armGroupLabels': ['JetStream XC with balloon angioplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Eastern Colorado Healthcare System', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33872', 'city': 'Sebring', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Heartland Medical Center', 'geoPoint': {'lat': 27.49559, 'lon': -81.44091}}, {'zip': '60515', 'city': 'Downers Grove', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Health', 'geoPoint': {'lat': 41.80892, 'lon': -88.01117}}, {'zip': '52722', 'city': 'Bettendorf', 'state': 'Iowa', 'country': 'United States', 'facility': 'Midwest Cardiovascular Research Foundation/Trinity Medical Center', 'geoPoint': {'lat': 41.52448, 'lon': -90.51569}}, {'zip': '52722', 'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'facility': 'Midwest Cardiovascular Research Foundation/Genesis Medical Center', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}, {'zip': '71103', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Endovascular Technologies, LLC', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '08205', 'city': 'Galloway', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Atlantic Medical Imaging', 'geoPoint': {'lat': 39.48788, 'lon': -74.47598}}, {'zip': '87101', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'New Mexico Heart Institute', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Promedica Toledo Hospital', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Science Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'US Departmetn of Veterans Affairs, Oklahoma VA Medical Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'VA North Texas Health Care System: Dallas VA Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Nicolas W Shammass, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Midwest Cardiovascular Research Foundation'}, {'name': 'Subhash Banerjee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VAMC, Dallas, Texas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be shared in aggregate in a manuscript. No plan to share individual patient data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Midwest Cardiovascular Research Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}