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Choosing an Access for Endovascular Treatment of Femoral-popliteal Segment Occlusions

NCT07694050 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2026-07-13

No results posted yet for this study

Summary

The aim of this study is to compare the shoulder and femoral approaches used in the endovascular treatment of occlusive lesions of the femoral-popliteal segment of the lower extremity arteries in terms of the frequency of complications. The aim of the study is to answer the following main questions: 1. Does the use of the shoulder approach reduce the overall number of complications compared to the femoral approach? 2. Does the use of the shoulder approach reduce the number of complications requiring surgical intervention compared to the femoral approach? 3. Does the use of a brachial approach reduce the number of technically successful interventions compared to a femoral approach? Researchers will compare the number of complications associated with a brachial approach compared to a femoral approach using closure devices for the revascularization of occlusions in the femoral-popliteal segment of the lower extremity arteries. During the planned revascularization procedure, participants will undergo catheterization of the brachial or common femoral artery. Complications related to radiation therapy will be recorded by doctors within 72 hours after the intervention.

Conditions

  • Occlusion of the Femoral-popliteal Segment
  • Femoral Access
  • Brachial Access

Interventions

PROCEDURE

Brachial artery catheterization

The puncture of the brachial artery was performed under ultrasound guidance. 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), 5 Fr diagnostic catheters 125 cm long (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 achieved by applying a pressure bandage. The access site was inspected again 3 hours after th

PROCEDURE

Femoral artery catheterization

The common femoral artery was punctured under ultrasound guidance. The femoral artery was catheterized at a typical site. 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), 5 Fr diagnostic catheters 125 cm long (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 a suturing device (AngioSeal, Terumo) through the femoral access. The access site was inspected agai

Sponsors & Collaborators

  • Pirogov Russian National Research Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2026-06-15
Completion
2026-06-18

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07694050 on ClinicalTrials.gov