Evaluation of Shoulder Access Safety Using the NewMan Compression Device (SAND)

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.

Study Overview

• Status: Completed
• Conditions: Brachial Access; Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities Occlusion of the Femoral-popliteal Segment; Access Complication; Compression Device; Hemostasis Compression Device
• Intervention / Treatment: Procedure: Hemostasis is performed using a pressure bandage; Procedure: Hemostasis is performed using the NewMan compression device

Detailed Description

The purpose of the study: 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 using the device or a pressure bandage.

Scientific hypotheses: 1. The use of the compression device in shoulder access has fewer complications compared to a pressure bandage. 2. The use of the compression device in shoulder access has fewer complications requiring surgical intervention compared to a pressure bandage. 3. The use of a compression device during shoulder access has a lower incidence of hematomas compared to a pressure bandage.

Inclusion criteria: an arterial diameter of at least 3 mm at the access site, indications for endovascular intervention on the lower extremity arteries, an age of 18 years or more, and patient consent to participate in the study.

Exclusion criteria: inability to perform access due to stenotic lesions of the above-mentioned arteries (axillary, subclavian arteries, brachiocephalic trunk); height exceeding 180 cm; presence of concomitant pathology limiting patients' survival; pathology of the blood coagulation system (hemophilia, thrombocytopathies, etc.), previously performed catheterization through the access artery.

The required sample size was calculated using the M. Blanda method for a study with increased accuracy. The required significance level (α) was 0.05, and the study's power was 95%. The estimated complication rates in the Brachial and NewMan groups were assumed to be 11% and 1%, respectively. Under these conditions, the estimated sample size was 141 patients. The planned loss rate during the study was 5%. Therefore, the minimum sample size was 148 patients.

The study has an experimental design and follows the CONSORT protocol. A simple method of randomization using a random number generator was selected.

The puncture of the brachial artery was performed under ultrasound control. The choice of hemostasis method was made by randomization using a random number generator, depending on this, the patient was assigned to one of the groups: a group using a compression device NewMan - NewMan or a pressure bandage - Brachial. The brachial artery was catheterized 2-3 cm above the elbow flexion. 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 or using the NewMan compression device (manufactured by NewMan Technologies, Russia).

A control examination of the access site was performed within 3 hours after the end of the intervention, and then, if there were no complaints, when the bandage was removed. After the bandage was removed, the patients underwent an ultrasound examination. Complications were recorded within 3 days after the intervention.

• Study Type: Interventional
• Enrollment (Actual): 229
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russia
  • Moscow, Russia, 117513
    • Central Clinical Hospital of St. Alexy Metropolitan of Moscow of the Moscow Patriarchate of the Russian Orthodox Church, Moscow

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Brachial; Hemostasis is performed using a pressure bandage	Procedure: 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
Experimental: NewMan; Hemostasis is performed using the NewMan compression device	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with hematoma at the access point with treatment-related adverse events as assessed by CTCAE v4.0	Number of participants with hematoma at the access point with treatment-related adverse events as assessed by CTCAE v4.0	Within 72 hours after artery catheterization
Number of participants with Acute artery occlusion with treatment-related adverse events as assessed by CTCAE v4.0	Number of participants with Acute artery occlusion with treatment-related adverse events as assessed by CTCAE v4.0	Within 72 hours after artery catheterization
Number of participants with Post-catheterization aneurysm that required surgery with treatment-related adverse events as assessed by CTCAE v4.0	Number of participants with Post-catheterization aneurysm that required surgery with treatment-related adverse events as assessed by CTCAE v4.0	Within 72 hours after artery catheterization
Number of participants with Technical success of access	Number of participants with Technical success of access	Perioperative/Periprocedural
Number of participants with Technical success of the index procedure	Number of participants with Technical success of the index procedure	Perioperative/Periprocedural
Number of participants with Conversion to another access	Number of participants with Conversion to another access	Perioperative/Periprocedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of complications	Total number of complications	Within 72 hours after radial artery catheterization
Total number of complications that required surgery	Total number of complications that required surgery	Within 72 hours after radial artery catheterization

Collaborators and Investigators

• Sponsor: Pirogov Russian National Research Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): June 15, 2026
• Study Completion (Actual): June 18, 2026

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: endovascular treatment; hemostasis; compression device; atherosclerosis of the arteries of the lower extremities; occlusion of the femoral-popliteal segment; brachial access; access complications
• Other Study ID Numbers: 261/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all personal data underlying the publication results
• IPD Sharing Time Frame: Beginning 6 months and ending 1 years after the publication of results
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No