Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
Study NCT ID:
NCT01355406
Status:
COMPLETED
Last Update Posted:
2018-06-29
First Post:
2011-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-10-09', 'releaseDate': '2020-09-16'}, {'resetDate': '2021-10-08', 'releaseDate': '2021-09-13'}], 'estimatedResultsFirstSubmitDate': '2020-09-16'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 257}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'dispFirstSubmitDate': '2017-10-13', 'completionDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-27', 'studyFirstSubmitDate': '2011-05-16', 'dispFirstSubmitQcDate': '2017-10-13', 'studyFirstSubmitQcDate': '2011-05-16', 'dispFirstPostDateStruct': {'date': '2017-10-17', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary safety endpoint is freedom from all cause death, TLR, or index limb amputation through 30 days.', 'timeFrame': '30 Days', 'description': 'The primary safety endpoint is defined as freedom from all cause death, index limb amputation and target lesion revascularization (TLR) through 30 days. The proportion of patients remaining free from this composite endpoint will be compared to a safety performance goal for bare nitinol stents.'}, {'measure': 'The primary efficacy endpoint is vessel patency at 12 months.', 'timeFrame': '12 Months', 'description': 'The primary efficacy endpoint is vessel patency at 12 months. Vessel patency is defined as freedom from a greater than 50% restenosis in the stented segment as determined by the DUS peak systolic velocity ratio (PSVR) comparing data within the treated segment to the proximal normal arterial segment and freedom from clinically-driven TLR within the stented segment within 1 year of the procedure.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['FlexStent', 'Superficial Femoral Artery or SFA', 'Self Expanding Stent', 'Stent', 'Bare Metal Stent'], 'conditions': ['Peripheral Artery Disease', 'Peripheral Vascular Disease', 'Vascular Disease', 'Cardiovascular Diseases', 'PAD']}, 'referencesModule': {'references': [{'pmid': '17377972', 'type': 'BACKGROUND', 'citation': 'Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G; VIVA Physicians, Inc. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007 May 1;69(6):910-9. doi: 10.1002/ccd.21104.'}]}, 'descriptionModule': {'briefSummary': 'This is a clinical study of a new self-expanding stent (FlexStent®) designed specifically to cope with the extreme demands of the superficial femoral artery (SFA)/proximal popliteal artery. The arteries are often abbreviated as femoropopliteal.\n\nThe intent of this study is to demonstrate that the FlexStent® Femoropopliteal Self-Expanding Stent System is safe and effective for the treatment of patients with peripheral arterial disease. Specifically, the FlexStent® shall meet or exceed the proposed safety and efficacy performance goals established for Femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll subjects must meet the following criteria:\n\n1. Subjects, male or female, must be at least 35 years of age at the time of consent. A female of childbearing potential may be enrolled, provided she has a negative pregnancy test within 7 days of screening.\n2. Subjects must give written informed consent prior to participation in the study and must understand the purpose of this study and be willing to adhere to the study procedures described in this protocol.\n3. Rutherford Classification Category 2-4\n4. De novo lesion in the Femoropopliteal artery, including the entire extent of the superficial femoral artery and the proximal portion of the popliteal artery extending to the medial condyle 3 cm above the knee joint\n5. Disease segment length ≤ 180 mm\n6. \\>70% diameter stenosis and/or occlusion based on site-determined visual angiography\n7. Patent ipsilateral iliac artery\n8. Patency of ipsilateral mid/distal popliteal artery and at least 1 tibial artery with no planned intervention\n9. Target reference vessel diameter 3.5-7.5 mm.\n10. Projected life expectancy of 12 months or greater\n11. Patient is available for follow-up for 36 months and is willing and able to comply with all follow-up requirements\n12. Patient is willing and able to provide signed informed consent\n\nExclusion Criteria:\n\nAny subject meeting any of the following criteria will be excluded from the study.\n\n1. Target vessel previously treated with a stent\n2. Target lesion within 1.5 cm of the ostium of the SFA\n3. Rutherford Classification Category 0,1,5 or 6\n4. Inability to tolerate antithrombotic or antiplatelet therapies\n5. Pregnancy (female of child-bearing age confirmed pregnant)\n6. Other comorbidity risks which in the opinion of the investigator limit longevity or likelihood of complying with protocol follow up.\n7. Serum creatinine \\> 2.5 mg/dL\n8. Myocardial infarction or stroke within 30 days of treatment date\n9. Known hypercoagulable state\n10. Known bleeding diathesis\n11. Untreated angiographically-evident thrombus in target vessel\n12. Patients currently enrolled in any other clinical trial'}, 'identificationModule': {'nctId': 'NCT01355406', 'acronym': 'OPEN', 'briefTitle': 'Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cordis US Corp.'}, 'officialTitle': 'Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System Study', 'orgStudyIdInfo': {'id': 'FSS-0003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PAD', 'description': 'This is a prospective single-arm multi-center clinical trial designed to evaluate the safety and efficacy of the Flexible Stenting Solutions Flext Stent® Femoropopliteal stenting system in subjects with lower limb peripheral arterial desease (PAD). Subjects targeted for enrollment must have a single de-novo lesion located in the superficial femoral artery and/or proximal popliteal artery with at \\> 70% stenosis. Subjects must meet all enrollment criteria and provide written informed consent prior to participation in the study.', 'interventionNames': ['Device: FlexStent® Femoropopliteal Self Expanding Stent System']}], 'interventions': [{'name': 'FlexStent® Femoropopliteal Self Expanding Stent System', 'type': 'DEVICE', 'otherNames': ['FlexStent®', 'OPEN'], 'description': 'Transcatheter over guidewire placement of an intravascular stent(s)', 'armGroupLabels': ['PAD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Abrazo Health Care Clinical & Trans. Research', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85364', 'city': 'Yuma', 'state': 'Arizona', 'country': 'United States', 'facility': 'Yuma Regional Medical Center', 'geoPoint': {'lat': 32.72532, 'lon': -114.6244}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'El Camino Hospital', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University/New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '34205', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Manatee Memorial Hospital', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '32605', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Research Network', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Memorial Hospital', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Cardiac & Vascular Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Mount Sinai Miami Medical Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Pepin Heart Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30901', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'University Hospital', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '62769', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': "St. John's Hospital", 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '52803', 'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'facility': 'Midwest Cardiovascular Research Foundation / Trinity Medical Center', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}, {'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Healient Physician Group', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '70506', 'city': 'Lafayette', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Lafayette General Medical Center', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'zip': '70601', 'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Christus St. Patrick Hospital', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}, {'zip': '71291', 'city': 'West Monroe', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Glenwood Regional Medical Center', 'geoPoint': {'lat': 32.51848, 'lon': -92.14764}}, {'zip': '20912', 'city': 'Takoma Park', 'state': 'Maryland', 'country': 'United States', 'facility': 'Washington Adventist Hospital / Center for Cardiac & Vascular Research', 'geoPoint': {'lat': 38.97789, 'lon': -77.00748}}, {'zip': '08015', 'city': 'Browns Mills', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Deborah Heart', 'geoPoint': {'lat': 39.97261, 'lon': -74.58293}}, {'zip': '08103', 'city': 'Haddon Heights', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cardiovascular Associates of the Delaware Valley', 'geoPoint': {'lat': 39.87734, 'lon': -75.06462}}, {'zip': '08103', 'city': 'Haddon Heights', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Our Lady of Lourdes Medical Center', 'geoPoint': {'lat': 39.87734, 'lon': -75.06462}}, {'zip': '07666', 'city': 'Teaneck', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Holy Name Medical Center', 'geoPoint': {'lat': 40.8976, 'lon': -74.01597}}, {'zip': '10001', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Gotham Cardiovascular Research, PC', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center, Center for Interventional Vascular Therapy', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28560', 'city': 'New Bern', 'state': 'North Carolina', 'country': 'United States', 'facility': 'CarolinaEast Health Center', 'geoPoint': {'lat': 35.10849, 'lon': -77.04411}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Rex Healthcare', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '58122', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Sanford Research/USD/Sanford Clinic', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United 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Specialists', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Providence Sacred Heart Medical Center / Providence Spokane Cardiology', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '53212', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Wisconsin Heart Hospital', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Aurora St. Luke's Medical Center / Aurora Medical Group", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '2820', 'city': 'Bonheiden', 'country': 'Belgium', 'facility': 'Imelda Hospital / Flanders Medical Research Program', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'zip': '9220', 'city': 'Dendermonde', 'country': 'Belgium', 'facility': 'A.Z. Sint-Blasius Hospital / Flanders Medical Research Program', 'geoPoint': {'lat': 51.02869, 'lon': 4.10106}}], 'overallOfficials': [{'name': 'William A. Gray, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Interventional Vascular Therapy / Columbia University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cordis US Corp.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, {'name': 'Prairie Education and Research Cooperative', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-09-16', 'type': 'RELEASE'}, {'date': '2020-10-09', 'type': 'RESET'}, {'date': '2021-09-13', 'type': 'RELEASE'}, {'date': '2021-10-08', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Cordis US Corp.'}}}}