Evaluation of Shoulder Access Safety Using the NewMan Compression Device

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.

NCT Number	NCT07714824
Lead Sponsor	Pirogov Russian National Research Medical University
Conditions	Brachial Access, Access Complication, Hemostasis Compression Device, Atherosclerosis of the Arteries of the Lower Extremities
Enrollment	229 participants
Start Date	2024-08-01
Primary Completion	2026-06-15 (estimated)
Study Completion	2026-06-18 (estimated)
Updated on ClinicalTrials.gov	2026-07-24