Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:33 PM
Study NCT ID:
NCT05082532
Status:
UNKNOWN
Last Update Posted:
2021-10-19
First Post:
2021-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Interwoven Self-Expandable Nitinol Stent for Femropopliteal Arterial Occlusive Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-05', 'studyFirstSubmitDate': '2021-09-03', 'studyFirstSubmitQcDate': '2021-10-05', 'lastUpdatePostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'peak systolic velocity in centimeters per second (cm/sec) through the deployed stent in serial duplex imaging', 'timeFrame': '4 years', 'description': 'Crossing the lesion and deploying the stent without residual stenosis or degree of stenosis is less than 30% and assess the time the stent remains patent without re interventions. the outcome will be measured on clinical aspect and imaging aspect. Clinically ,investigators will trace the ankle brachial index (ankle systolic pressure relative to systemic systolic pressure), wound healing progress through cascade measuring of ulcer diameter in centimeters till complete healing and pain improvement depending on visual analogue score from 0 to 10.Imaging follow up, investigators will trace diseased segment diameters after intervention in millimeters and peak systolic velocity through the stent in centimeters per second.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Femoropopliteal Occlusive Disease']}, 'referencesModule': {'references': [{'pmid': '19624075', 'type': 'BACKGROUND', 'citation': 'Mewissen MW. Primary nitinol stenting for femoropopliteal disease. J Endovasc Ther. 2009 Apr;16(2 Suppl 2):II63-81. doi: 10.1583/08-2658.1.'}]}, 'descriptionModule': {'briefSummary': 'Interwoven self-expandable stent is a recent endovascular method to treat complex femoropopliteal lesions trying to reach a reasonable patency and durability like in surgical bypass.', 'detailedDescription': 'Stenting of the femoro-popliteal segment is indicated in case of elastic recoil, flow-limiting dissection, insufficient per- cutaneous transluminal angioplasty (PTA) or long lesion length. However, in-stent restenosis (ISR) or fracture after endovascular treatment remains a serious concern, especially for lesions of a long segment or near the knee joint. Besides the current availability of covered or drug-coated stents, there is the self-expandable bare-metal Nitinol stent which rapidly evolved during the last decade from closed-cell to open-cell and, more recently, to interwoven stents. interwoven nitinol stent design of fully connected structures facilitates a continuous but a traumatic synergy between the stent and vessel wall and hence enables axial compliance. Investigators here conduct a prospective study to evaluate the efficacy and safety of self- expandable nitinol stent especially interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) in femoropopliteal complex occlusive lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients with critical limb ischemia(grade 4,5\\&6 Rutherford classification) and patients with disabling claudications which interferes with routine activities (grade 3 Rutherford classification).\n* Patients with chronic total occlusion(CTO) of femoropopliteal segment which is equal or beyond 10 centimeters length.\n* Patients with recoil after transluminal angioplasty or occlusion in previously deployed stent.\n* If the lesion extends to popliteal artey against knee flexion.\n\nExclusion criteria:\n\n* Pediatric patients.\n* Patients with isolated infra-popliteal occlusion.\n* Patients with popliteal blind segment with bad runoff.\n* Patients with acute thrombotic occlusions.\n* Patients with previous bypass surgery in affected limb.\n* Patients with aneurysmal lesion in the affected limb.'}, 'identificationModule': {'nctId': 'NCT05082532', 'briefTitle': 'Efficacy and Safety of Interwoven Self-Expandable Nitinol Stent for Femropopliteal Arterial Occlusive Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Efficacy and Safety of Interwoven Self-Expandable Nitinol Stent for Femropopliteal Arterial Occlusive Diseases', 'orgStudyIdInfo': {'id': 'SUPERA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients with critical and subcritical femoropopliteal arterial occlusions', 'description': 'patients presented with chronic ischemia in rest pain stage or ulcerative and gangrenous toes and by investigations long chronic total occlusion of femoropopliteal segment was documented may need stenting of the diseased segment especially if the lesion recoils after previous angioplasty. Nitinol interwoven stent has a unique design that achieves adherence to vessel wall and also malleability with the vessel and surrounding muscle motion so investigators predict more extended patency time with this interventional option and want to investigate this prediction using a scientific experimental pathway.', 'interventionNames': ['Other: Interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) .']}], 'interventions': [{'name': 'Interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) .', 'type': 'OTHER', 'description': 'we here conduct a prospective study to evaluate the efficacy and safety of self- expandable nitinol stent especially interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) in femoropoliteal complex occlusive lesions.', 'armGroupLabels': ['patients with critical and subcritical femoropopliteal arterial occlusions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '+20', 'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'ahmed A hussein', 'role': 'CONTACT', 'email': 'ahmednaserhussein7@yahoo.com'}], 'facility': 'Assiut university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'ahmed A hussein, master of vascular surgery', 'role': 'CONTACT', 'email': 'ahmednaserhussein7@yahoo.com', 'phone': '+20-088-0291608774'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Ahmed Naser Hussein', 'investigatorAffiliation': 'Assiut University'}}}}