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Evaluation of Shoulder Access Safety Using the NewMan Compression Device
Sponsor: Pirogov Russian National Research Medical University
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
229
Start Date
2024-08-01
Completion Date
2026-06-18
Last Updated
2026-07-20
Healthy Volunteers
No
Conditions
Interventions
Hemostasis is performed using a pressure bandage
The puncture of the brachial artery was performed under ultrasound control. The brachial artery was catheterized 2-3 cm above the elbow crease. The following instruments were used to perform the intervention: an 18G angiographic needle 7 cm long, a 0.035-inch diagnostic guide 260 cm, a 6 Fr 90 cm guide introducer (Destination, manufacturer Terumo), diagnostic catheters 5 Fr in diameter and 125 cm in length (Optitorque, manufacturer Terumo or Impress, manufacturer Merit Medical), peripheral conductors 0.035 or 0.018 inches, balloon catheters with a delivery length of 150 cm and 180 cm (Atropos, manufacturer of BrosMed; Pacific Plus, manufacturer of Medtronic) and balloon catheters for peripheral arteries with a drug coating of paclitaxel and a delivery system length of 150 cm (Ranger, manufacturer of Boston Scientific). 5,000 IU of heparin in saline solution was injected into the catheterized artery. Hemostasis was achieved by applying a classic pressure bandage. The access site was ins
Hemostasis is performed using the NewMan compression device
The puncture of the brachial artery was performed under ultrasound control. The brachial artery was catheterized 2-3 cm above the elbow crease. The following instruments were used to perform the intervention: an 18G angiographic needle 7 cm long, a 0.035-inch diagnostic guide 260 cm, a 6 Fr 90 cm guide introducer (Destination, manufacturer Terumo), diagnostic catheters 5 Fr in diameter and 125 cm in length (Optitorque, manufacturer Terumo or Impress, manufacturer Merit Medical), peripheral conductors 0.035 or 0.018 inches, balloon catheters with a delivery length of 150 cm and 180 cm (Atropos, manufacturer of BrosMed; Pacific Plus, manufacturer of Medtronic) and balloon catheters for peripheral arteries with a drug coating of paclitaxel and a delivery system length of 150 cm (Ranger, manufacturer of Boston Scientific). 5000 IU of heparin in saline solution was injected into the catheterized artery. Hemostasis was performed using the NewMan compression device. The access site was inspec
Locations (1)
Central Clinical Hospital of St. Alexy Metropolitan of Moscow of the Moscow Patriarchate of the Russian Orthodox Church, Moscow
Moscow, Russia