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Completed NCT07714824

Evaluation of Shoulder Access Safety Using the NewMan Compression Device

Conditions: Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities Occlusion of the Femoral-popliteal Segment, Brachial Access, Access Complication, Compression Device, Hemostasis Compression Device

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 229
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 the study is to evaluate the effectiveness of the NewMan compression device in shoulder access in patients with occlusive lesions of the femoral-popliteal segment of the lower extremity arteries by comparing the frequency of access complications when it is used or when a pressure bandage is used. The objectives of the study are to answer the following main questions: 1. Does the use of a compression device in shoulder access reduce the overall number of complications compared to an occlusive bandage? 2. Does the use of a compression device during shoulder access reduce the number of complications requiring surgical intervention compared to an occlusive bandage? 3. Does the use of a compression device during shoulder access reduce the number of hematomas in the access area compared to an occlusive bandage? The researchers will compare the number of complications associated with shoulder access when using a compression device and an occlusive bandage for the revascularization of femoral-popliteal segment occlusions of the lower extremity arteries. During the routine revascularization procedure, participants will undergo a catheterization of the brachial artery. Complications related to radiation therapy will be recorded by doctors within 72 hours of 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 18 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 (axillary, subclavian arteries, and brachiocephalic trunk) * height exceeding 180 cm; presence of concomitant pathology that limits patient survival; pathology of the blood coagulation system (hemophilia, thrombocytopathies, etc.) * previous catheterizations performed through the access artery

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07714824). StuddyBuddy aggregates publicly available trial information.