Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-04-15 @ 1:08 AM
Study NCT ID:
NCT05522218
Status:
RECRUITING
Last Update Posted:
2024-09-27
First Post:
2022-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eluvia DES for the Patients with Femoropopliteal Artery Lesions.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014652', 'term': 'Vascular Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-25', 'studyFirstSubmitDate': '2022-08-24', 'studyFirstSubmitQcDate': '2022-08-28', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of Rutherfor classification', 'timeFrame': '24 months', 'description': 'Comparison of preoperative Rutherford classification and postoperative Rutherford classification at 24 months'}, {'measure': 'F-TLR', 'timeFrame': '24 months', 'description': 'free of target vascular reconstruction'}, {'measure': 'limb salvage rate', 'timeFrame': '24 months', 'description': 'Proportion of patients without ambutation'}], 'secondaryOutcomes': [{'measure': 'Technical success rate', 'timeFrame': '1 month', 'description': 'Percentage of patients with successful endovascular treatment without postoperative complications'}, {'measure': 'the patency target lesion', 'timeFrame': '24 months', 'description': 'Restenosis was defined as PSVR \\> 2.4 as determined by vascular ultrasonography'}, {'measure': 'mortality rate', 'timeFrame': '24 months', 'description': 'the propotion of death'}, {'measure': 'the life quality change', 'timeFrame': '24 months', 'description': 'Amount by Vas-Qol questionare between perioperation and 24month postoperation'}, {'measure': 'the life quality change', 'timeFrame': '24 months', 'description': 'Amount by EQ-5D5L questionare between perioperation and 24month postoperation'}, {'measure': 'Economics Evaluation', 'timeFrame': '24 months', 'description': 'Cumulative hospitalization expenses related to treatment within 24 months'}, {'measure': 'Wound Healing Evaluation', 'timeFrame': '24 months', 'description': 'If there is an ulcer wound, evaluate the ulcer wound healing at 24 months after surgery and before treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vascular Diseases', 'Stent Complication']}, 'descriptionModule': {'briefSummary': 'This study is a multicenter, prospective, observational study, aiming to enroll 400 patients with peripheral arterial disease in the femoral-popliteal segment implanted with Eluvia stent. Each patient was followed up for 2 years. The technical success rate, target lesion patency rate, quality of life improvement, cost of Eluvia stent implantation, and other outcomes will be analysed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'peripheral arterial disease patients implanted with Eluvia stent', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Rutherford Stage 2-5.\n2. At least 90% stenosis or occlusion of the femoropopliteal artery.\n3. Eluvia stents are used for target lesions.\n4. Agree and sign the informed consent form\n\nExclusion Criteria:\n\n1. Life expectancy is less than 1 year.\n2. Those with severe infection and gangrene of the limbs or those with tissue defects beyond the plane of the toes (ie major tissue loss), who may undergo major amputation even if the blood vessels are opened.\n3. Patients and their families are reluctant to join the observational study, or have difficulty in communication and are unable to assess the quality of life.\n4. Patients with in-stent restenosis of the femoral popliteal artery.\n5. Patients with acute arterial thrombosis.'}, 'identificationModule': {'nctId': 'NCT05522218', 'briefTitle': 'Eluvia DES for the Patients with Femoropopliteal Artery Lesions.', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Zhejiang University'}, 'officialTitle': 'Clinical Effectiveness and Health Economic Evaluation of Eluvia Drug-eluting Stent in the Treatment of Femoropopliteal Artery Lesions', 'orgStudyIdInfo': {'id': 'IIT20220166B-X1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Eluvia drug eluting stent', 'type': 'DEVICE', 'description': 'Eluvia drug eluting stent for peripheral arterial disease'}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ziheng Wu, PhD', 'role': 'CONTACT', 'email': 'wuziheng@zju.edu.cn', 'phone': '0571-87236745'}], 'facility': 'First Affiliated Hospital of Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'After recruitment, data will be shared after 2 years of follow-up'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated chief physician', 'investigatorFullName': 'Ziheng Wu, MD', 'investigatorAffiliation': 'First Affiliated Hospital of Zhejiang University'}}}}