Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-04-19 @ 5:45 AM
Study NCT ID:
NCT02209350
Status:
COMPLETED
Last Update Posted:
2025-01-15
First Post:
2014-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the AFB and Stenting of the Iliac Arteries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077144', 'term': 'Clopidogrel'}], 'ancestors': [{'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-12', 'studyFirstSubmitDate': '2014-07-30', 'studyFirstSubmitQcDate': '2014-08-01', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical success', 'timeFrame': '1 day', 'description': 'Successful implantation of all devices without the need for conversion and with residual stenosis less than 30%'}, {'measure': '30-day complication rate', 'timeFrame': '30 days', 'description': 'clinically significant bleeding, hematoma, infection of the prosthesis, infection of postoperative wound, lymphorrhea, renal failure, myocardial infarction, stroke, mortality, thrombosis of the operated segment, distal embolism'}, {'measure': '30-day primary patency rates', 'timeFrame': '30 days', 'description': 'during the whole 30 days from the date of intervention. confirmation of patency of the arterial ultrasound of the operated segment.'}, {'measure': '30-day secondary patency rates', 'timeFrame': '30-day', 'description': 'during the whole 30 days from the date of intervention. confirmation of patency of the arterial ultrasound of the operated segment after reintervention due to thrombosis'}], 'secondaryOutcomes': [{'measure': 'Major adverse cardiovascular event (MACE)', 'timeFrame': '36 months', 'description': 'composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death'}, {'measure': 'Limb salvage', 'timeFrame': '36 months', 'description': 'preservation of a functional foot, eliminating the necessity for major amputation'}, {'measure': 'Amputation-free survival', 'timeFrame': '36 months', 'description': 'freedom from major limb amputation or death by any cause'}, {'measure': 'Primary patency rates', 'timeFrame': '36 months', 'description': 'no occlusion or significant flow-limiting stenosis in the treated segment'}, {'measure': 'Secondary patency rates', 'timeFrame': '36 months', 'description': 'no occlusion or flow-limiting stenosis following at least one re-intervention aimed at restoring patency, in addition to all instances of primary patency'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Aorta-iliac Segment Lesion (C,D Type by TASC II)']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare effectiveness and long-term results of aorta-femoral reconstructions and endovascular treatment in the patients with aorta-iliac lesions (TASC C,D).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with unilateral steno-occlusive iliac lesions (TASC types C, D) and with chronic lower limb ischemia\n* Rutherford classification category 3-5 chronic limb ischemia,\n* age: 45-75 years old.\n* Patients who consented to participate in this study.\n\nExclusion Criteria:\n\n* Aortic thrombosis, concomitant abdominal aortic or iliac aneurysms, acute limb ischemia or vasculitis;\n* Flush occlusion of the common iliac artery;\n* Ipsilateral common femoral arteries steno-occlusive disease (occlusion or stenosis \\>50%);\n* Ipsilateral profunda femoris artery steno-occlusive disease (occlusion or stenosis \\>50%);\n* Refusal to participate in the study;\n* Stroke or myocardial infarction within the past 3 months;\n* Ischemic heart disease with New York Heart Association functional class IV;\n* Malignant tumor with an estimated life span of under 6 months;\n* Previous ipsilateral or contralateral surgery (bypass, hybrid or stenting);\n* Hepatic or renal insufficiency (bilirubin\\> 35 mmol/l, glomerular filtration rate \\<60 ml/min/1.73 m2);\n* Severe calcification of the aorta and iliac arteries intolerant to balloon angioplasty (as determined by the Peripheral Arterial Calcification Scoring System on computed tomography angiography as interpreted by a vascular radiologist):12\n* unilateral calcification ≥ 5cm (Grade 2), bilateral calcification ≥ 5cm (Grade 4) or circumferential calcification , defined as 270°-360° around the circumference of aorta and/or iliac arteries.'}, 'identificationModule': {'nctId': 'NCT02209350', 'briefTitle': 'Study of the AFB and Stenting of the Iliac Arteries', 'organization': {'class': 'NETWORK', 'fullName': 'Meshalkin Research Institute of Pathology of Circulation'}, 'officialTitle': 'Prospective Randomized Clinical Study of the Aorto-femoral Bypass and the Iliac Arteries With Stenting Recanalization Effectiveness in Patients With the Iliac Segment Occlusive Disease', 'orgStudyIdInfo': {'id': 'TASC C,D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Operations technique on the abdominal aorta. Aorta-femoral bypass. Medication: after surgery all patients are prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).', 'interventionNames': ['Procedure: Aorta-femoral bypass', 'Drug: Therapy: aspirin and clopidogrel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Standard endovascular treatment (stenting) in patients with the iliac segment occlusive disease. Medication: after stenting all patients are prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).', 'interventionNames': ['Procedure: Recanalization and stenting of aorta-iliac segment', 'Drug: Therapy: aspirin and clopidogrel']}], 'interventions': [{'name': 'Aorta-femoral bypass', 'type': 'PROCEDURE', 'description': 'Access to the femoral artery is performed through a lateral incision from the inguinal ligament. Operations technique on the abdominal aorta.\n\nAorta-femoral bypass. Proximal anastomosis between the prosthesis and aorta is applied in the sort of "end-to-side" in the reconstruction by shunting.\n\nAfter jaws prosthesis conduction on hip distal anastomosis is formed with twisting controlling. In a case of preserved antegrade blood flow the femoral artery anastomosis applied in the sort of "end-to-side". If antegrade flow is absent, anastomosis is formed in the sort of "end to end".', 'armGroupLabels': ['Group 1']}, {'name': 'Recanalization and stenting of aorta-iliac segment', 'type': 'PROCEDURE', 'description': 'Standard endovascular access is performed under local anesthesia and affected arterial segment is visualized.\n\nStenosis or artery occlusion is passed with hydrophilic guide. In case of occlusion transluminal or subintimal (often "mixed") artery recanalization is performed. To maximize the preservation of the affected artery initial patency, occlusion recanalization is performed by ante-and retrograde accesses. Then stenosis or occlusion predilation is performed with balloon catheter (balloon catheter diameter is smaller than the affected artery diameter for 1-2 mm). After control angiography stent is installed in the aorta-iliac area throughout the lesion (lesion diameter corresponds to the stenotic arteries diameter).', 'armGroupLabels': ['Group 2']}, {'name': 'Therapy: aspirin and clopidogrel', 'type': 'DRUG', 'description': 'prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '630055', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Novosibirsk Research Institute of Circulation Pathology', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}], 'overallOfficials': [{'name': 'Andrey Karpenko, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Novosibirsk Research Institute of Circulation Pathology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meshalkin Research Institute of Pathology of Circulation', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}