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Completed NCT07694050

Choosing an Access for Endovascular Treatment of Femoral-popliteal Segment Occlusions

Conditions: Occlusion of the Femoral-popliteal Segment, Femoral Access, Brachial Access

Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 304
Sponsor: Pirogov Russian National Research Medical University

Location: Central Clinical Hospital of St. Alexy Metropolitan of Moscow of the Moscow Patriarchate of the Russian Orthodox Church, Moscow Moscow

Summary

The aim of this study is to compare the shoulder and femoral approaches used in the endovascular treatment of occlusive lesions of the femoral-popliteal segment of the lower extremity arteries in terms of the frequency of complications. The aim of the study is to answer the following main questions: 1. Does the use of the shoulder approach reduce the overall number of complications compared to the femoral approach? 2. Does the use of the shoulder approach reduce the number of complications requiring surgical intervention compared to the femoral approach? 3. Does the use of a brachial approach reduce the number of technically successful interventions compared to a femoral approach? Researchers will compare the number of complications associated with a brachial approach compared to a femoral approach using closure devices for the revascularization of occlusions in the femoral-popliteal segment of the lower extremity arteries. During the planned revascularization procedure, participants will undergo catheterization of the brachial or common femoral artery. Complications related to radiation therapy will be recorded by doctors within 72 hours after the intervention.

Eligibility Criteria

Inclusion criteria: * arterial diameter at the access site of at least 3 mm, indications for endovascular intervention on the lower extremity arteries, * age of 60 years or more, and patient consent to participate in the study. Exclusion criteria: * inability to perform an access due to stenotic lesions of the above-mentioned arteries (common femoral artery, iliac arteries, axillary artery, subclavian artery, and brachiocephalic trunk); * height exceeding 180 cm; * presence of concomitant pathology that limits patient survival; coagulation system pathology (hemophilia, thrombocytopathies, etc.) * previous arterial access catheterizations.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07694050). StuddyBuddy aggregates publicly available trial information.