Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
Study NCT ID:
NCT04584632
Status:
RECRUITING
Last Update Posted:
2025-02-21
First Post:
2020-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients with Symptomatic Peripheral Vascular Disease from Stenosis or Occlusion of the Femoropopliteal Artery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D003251', 'term': 'Constriction, Pathologic'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-20', 'studyFirstSubmitDate': '2020-09-30', 'studyFirstSubmitQcDate': '2020-10-06', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Target lesion percent mean diameter stenosis', 'timeFrame': 'Post procedure (Day 0) and 6 months'}, {'measure': 'Target lesion percent maximum diameter stenosis', 'timeFrame': 'post procedure (day 0) and at 6 months'}, {'measure': 'Target lesion late lumen loss', 'timeFrame': '6 months'}, {'measure': 'Ischemia-driven target lesion revascularization (IDTLR)', 'timeFrame': '1, 6, 12, 24 and 36 months'}, {'measure': 'Amputation (minor and major) of the target extremity', 'timeFrame': '1, 6, 12, 24 and 36 months'}], 'primaryOutcomes': [{'measure': 'Major Adverse Event (MAE)', 'timeFrame': '30 days'}, {'measure': 'Freedom from Binary Restenosis', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Device Success', 'timeFrame': 'Day 0', 'description': 'Achievement of successful delivery and deployment of the study device(s) at the intended target lesion'}, {'measure': 'Primary patency rate', 'timeFrame': '1, 6, 12, 24 and 36 months'}, {'measure': 'Binary restenosis rate', 'timeFrame': '1, 6, 12, 24 and 36 months'}, {'measure': 'Target lesion revascularization (TLR)', 'timeFrame': '1, 6, 12, 24 and 36 months'}, {'measure': 'Ipsilateral extremity revascularization (IER)', 'timeFrame': '1, 6, 12, 24 and 36 months'}, {'measure': 'Number of patients with Scaffold thrombosis', 'timeFrame': 'through 1 month'}, {'measure': 'Number of patients with scaffold occlusion', 'timeFrame': '6, 12, 24 and 36 months'}, {'measure': 'Rate of Major Adverse Limb Events', 'timeFrame': 'through 36 months'}, {'measure': 'Ankle-brachial index (ABI) of target extremity', 'timeFrame': '1, 6, 12, 24 and 36 months'}, {'measure': 'Limb salvage of target extremity', 'timeFrame': '1, 6, 12, 24 and 36 months'}, {'measure': 'Rutherford-Becker Clinical Category for the target extremity', 'timeFrame': '1, 6, 12, 24 and 36 months'}, {'measure': 'Walking impairment as assessed by Walking Impairment Questionnaire (WIQ)', 'timeFrame': '1, 6, 12, 24 and 36 months'}, {'measure': 'Clinical Success', 'timeFrame': 'Up to 2 days after procedure', 'description': 'Attainment of a final residual stenosis of \\<30% using the study device(s) and/or any adjunctive device at the intended target lesion without complications'}, {'measure': 'Technical Success', 'timeFrame': 'Day 0', 'description': 'Attainment of a final residual stenosis of \\<30% at the intended target lesion('}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peripheral Artery Disease', 'Bioresorbable'], 'conditions': ['Peripheral Arterial Disease', 'Vascular Diseases', 'Stenosis', 'Femoropopliteal Stenosis']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and performance of the EVSS in patients with symptomatic peripheral vascular disease from stenosis or occlusion of the femoropopliteal artery', 'detailedDescription': 'The EFEMORAL I study is a prospective, single-arm, open-labeled, multi-center, clinical investigation enrolling patients with arterial diameter of ≥5.5 mm and ≤6.5 mm and lesion length ≤90 mm receiving a single EVSS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Symptomatic peripheral vascular occlusive disease (Rutherford-Becker Clinical Category 2-4)\n* Patient with life expectancy \\>36 months\n* Females of childbearing potential must have negative pregnancy test\n* Patient is able to provide informed consent\n* Patient agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site.\n* Patient must be able to take antiplatelet and/or anticoagulant agents as prescribed\n* Single de novo native disease segment of the superficial femoral artery (SFA) or P1 popliteal segment\n* Reference vessel diameter ≥5.5 mm and ≤6.5 mm\n* Target lesion length ≤90 mm\n* Target lesion with ≥50% DS\n* Inflow artery and popliteal artery free from flow-limiting lesion (DS \\<50%)\n\nExclusion Criteria:\n\n* Hemoglobin \\<9.0 g/dL\n* WBC \\<3,000 cells/mm3\n* Platelet count \\<80,000 cells/mm3 or \\>700,000 cells/mm3\n* Acute or chronic renal dysfunction with creatinine \\>2.5 mg/dl (176 µmol/L)\n* Severe liver impairment as defined by total bilirubin ≥3 mg/dl or two times increase over the normal level of SGOT or SGPT\n* A known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, ticagrelor or sirolimus, or with contrast sensitivity for which the patient cannot be adequately pre-medicated\n* Patient requires a planned procedure that would necessitate discontinuation of antiplatelet therapy\n* Patient is unable to walk\n* Patient has undergone a percutaneous vascular intervention \\<30 days prior to the planned index procedure\n* Patient is maintained on chronic hemodialysis\n* Patient has uncontrolled diabetes mellitus (HbA1c ≥7.0%).\n* Patient has had a myocardial infarction within the previous 30 days of the planned index procedure\n* Patient has had a stroke within the previous 30 days of the planned index procedure and/or has deficits from a prior stroke that limits the patient's ability to walk\n* Patient has unstable angina defined as rest angina with ECG changes\n* Patient has a local groin or acute systemic infection that has not been treated successfully or is currently under treatment\n* Patient has acute thrombophlebitis, deep vein thrombosis or chronic venous insufficiency in either extremity\n* Patient has other medical illnesses (e.g., cancer, congestive cardiomyopathy, etc.) that may cause the patient to be non-compliant with protocol requirements, confound the data interpretation or will prevent completion of all required follow up assessments through 36 months\n* Patient is currently participating in an investigational drug, biologic, or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints\n* Patient has ischemic or neuropathic ulcers on either foot\n* Patient has undergone minor or major amputation of either lower extremity\n* Patient is part of a vulnerable population who, in the judgment of the Investigator, is unable to give informed consent\n* Target extremity with an angiographically significant (\\>50% DS) lesion located distal to the target lesion that requires treatment at the time of the index procedure or by a staged procedure\n* Acute arterial ischemia of the target extremity\n* Target extremity has been previously treated with open surgical revascularization (bypass or endarterectomy)\n* Target vessel has been previously treated with stent, laser, atherectomy, surgical bypass, or endarterectomy\n* Total occlusion (100% DS) of the ipsilateral inflow artery\n* Angiographic evidence of thrombus in the target vessel\n* The target lesion requires treatment with a device other than percutaneous transluminal balloon angioplasty (PTA) \\[e.g., orbital atherectomy, directional atherectomy, excimer laser, rotational atherectomy, cryoplasty, etc.\\]\n* Target lesion is within or adjacent to an aneurysm\n* Patient has angiographic evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion or from crossing or pre-dilating the target lesion\n* Target lesion has moderate-to-severe calcification\n* Target lesion with \\> 30% residual stenosis following pre-dilatation"}, 'identificationModule': {'nctId': 'NCT04584632', 'acronym': 'Efemoral I', 'briefTitle': 'The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients with Symptomatic Peripheral Vascular Disease from Stenosis or Occlusion of the Femoropopliteal Artery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Efemoral Medical, Inc.'}, 'officialTitle': 'A Clinical Evaluation of the Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients with Symptomatic Peripheral Vascular Disease from Stenosis or Occlusion of the Femoropopliteal Artery', 'orgStudyIdInfo': {'id': 'CL05122020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EVSS', 'description': 'Efemoral Vascular Scaffold System (EVSS)', 'interventionNames': ['Device: Efemoral Vascular Scaffold System (EVSS)']}], 'interventions': [{'name': 'Efemoral Vascular Scaffold System (EVSS)', 'type': 'DEVICE', 'description': 'Balloon-expandable, bioresorbable vascular scaffolds coated with sirolimus', 'armGroupLabels': ['EVSS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sydney', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Ramon Varcoe, MD', 'role': 'CONTACT'}], 'facility': 'Prince Of Wales Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '1142', 'city': 'Auckland', 'status': 'RECRUITING', 'country': 'New Zealand', 'contacts': [{'name': 'Andrew Holden, MD', 'role': 'CONTACT', 'email': 'andrewh@adhb.govt.nz', 'phone': '6493670000'}], 'facility': 'Auckland City Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Christchurch', 'status': 'RECRUITING', 'country': 'New Zealand', 'contacts': [{'name': 'Ruth Benson, MD', 'role': 'CONTACT'}], 'facility': 'Christchurch Hospital', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'city': 'Hamilton', 'status': 'RECRUITING', 'country': 'New Zealand', 'contacts': [{'name': 'Manar Khashram, MD', 'role': 'CONTACT'}], 'facility': 'Waikato Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}], 'centralContacts': [{'name': 'Lew Schwartz, MD', 'role': 'CONTACT', 'email': 'lewis.schwartz@efemoralmedical.com', 'phone': '224-707-2601'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Efemoral Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}