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

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.