Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT01420120
Status:
COMPLETED
Last Update Posted:
2015-07-16
First Post:
2011-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remedy, Biodegradable Peripheral Stent Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-15', 'studyFirstSubmitDate': '2011-08-16', 'studyFirstSubmitQcDate': '2011-08-18', 'lastUpdatePostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absence of clinically driven target lesion revascularization at 12 months.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Technical success', 'timeFrame': 'During procedure', 'description': 'Defined as a successful access and deployment of the device and determined by less than 30% residual stenosis by angiography at the baseline procedure.'}, {'measure': 'Clinical success', 'timeFrame': 'During procedure', 'description': 'Defined as technical success without the occurrence of serious adverse events during procedure'}, {'measure': 'Primary and secondary patency rate', 'timeFrame': '12 months', 'description': 'defined as \\< 50% diameter reduction and peak systolic velocity \\< 2.4 at 12 months.'}, {'measure': 'Ankle-Brachial Index improvement of ≥ 0.1', 'timeFrame': '1, 6 and 12 months'}, {'measure': 'Clinically driven target vessel revascularization', 'timeFrame': '6 and 12 months'}, {'measure': 'Major complications at 6 and 12 months, including amputation of a part of the foot, the leg below and above the knee.', 'timeFrame': '6 and 12 months'}, {'measure': 'Rutherford-Becker classification of chronic limb ischemia', 'timeFrame': '1, 6 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Biodegradable stent, PAD'], 'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'This is a prospective multicenter registry to evaluate safety and performance of the REMEDY, biodegradable peripheral stent for the treatment of occluded or stenotic superficial femoral arteries. Patients will be followed for a period of 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with documented symptomatic occlusion and/or \\> 70% stenosis of SFA.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with symptomatic leg ischemia requiring treatment of SFA artery or proximal popliteal artery located within the following parameters:\n\n * 1 cm from the femoral bifurcation in the SFA\n * 3 cm from the proximal margin of the intercondylar fossa\n* Rutherford-Becker Category 2-5. In patients with bilateral lesions, the highest Rutherford Category limb should be treated. Only 1 leg can be included.\n* Single lesion which can be covered by one stent.\n* Target vessel reference diameter ≥ 4 mm and ≤ 6 mm (by visual estimate)\n* A patent popliteal artery free from significant stenosis (\\>50%) with at least one patent vessel runoff as confirmed by baseline angiography\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Pregnancy\n* Previous stenting of target lesion\n* Acute ischemia\n* Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion). Inclusion of a patient is allowed in case inflow lesions are successfully treated during the index-procedure yielding less than 30% diameter stenosis.\n* Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy\n* Known intolerance to study medications or contrast agents.'}, 'identificationModule': {'nctId': 'NCT01420120', 'briefTitle': 'Remedy, Biodegradable Peripheral Stent Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'be Medical'}, 'officialTitle': 'A Prospective Multicenter Registry to Evaluate Safety and Performance of REMEDY, Biodegradable Peripheral Stent for the Treatment of Occluded or Stenotic Superficial Femoral Arteries.', 'orgStudyIdInfo': {'id': 'BM-REM-03-003'}}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'be Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Joris Coteur, study coordinator', 'oldOrganization': '.be medical'}}}}