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

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.

Study Overview

• Status: Completed
• Conditions: Femoral Access Site Closure; Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities; Occlusion of the Femoral-popliteal Segment; Femoral Access; Brachial Access; Access Complications
• Intervention / Treatment: Procedure: Brachial artery catheterization; Procedure: Femoral artery catheterization

Detailed Description

The purpose of the study: to compare the complication rate of the shoulder and retrograde femoral access in elderly patients with occlusive lesions of the femoral-popliteal segment of the lower extremity arteries.

Scientific hypotheses:

1. The shoulder access has a lower number of complications compared to the femoral access
2. The shoulder access has a lower number of complications requiring surgical intervention compared to the femoral access
3. The shoulder access has a comparable % of success of the main intervention with the femoral access Inclusion criteria: arterial diameter at the access site of at least 3 mm, indications for endovascular intervention on the lower extremity arteries, age of 60 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 (common femoral, iliac, axillary, subclavian arteries, brachiocephalic trunk); height more than 180 cm; presence of concomitant pathology limiting the survival of patients; 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 [3] for a study with increased accuracy. The required level of significance (α) was 0.05, and the study's power was 95%. The estimated complication rates in the Femoral and Brachial groups were assumed to be 2% and 9%, respectively. Under these conditions, the estimated sample size was 269 patients. The planned loss rate during the study was 5%. Therefore, the minimum sample size was 283 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 or common femoral artery was performed under ultrasound control. The choice of the type of arterial access was made by randomization using a random number generator, and depending on this choice, the patient was assigned to one of the groups: the Femoral access group or the Brachial access group. The femoral artery was catheterized at a typical location, and the brachial artery was catheterized 2-3 cm above the elbow. The choice of access location was made by randomization using the random number method, and the patient was assigned to one of the groups based on this choice. 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). 5,000 IU of heparin in saline solution was injected into the catheterized artery. Hemostasis was achieved by applying a pressure bandage in the case of a shoulder access or by using a suturing device (AngioSeal, Terumo) in the case of a femoral access.

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, 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): 304
• 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 60 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 (common femoral artery, iliac arteries, axillary artery, subclavian artery, and brachiocephalic trunk); height exceeding 180 cm; presence of concomitant pathology that limits patient survival; coagulation system pathology (hemophilia, thrombocytopathies, etc.), and previous arterial access catheterizations.

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; Brachial artery catheterization	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
Experimental: Femoral; Femoral artery catheterization	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hematoma at the access point	Hematoma at the access point	Within 72 hours after artery catheterization
Acute artery occlusion	Acute artery occlusion	Within 72 hours after artery catheterization
Post-catheterization aneurysm that required surgery	Post-catheterization aneurysm that required surgery	Within 72 hours after radial artery catheterization
Technical success of access	Technical success of access	Perioperative/Periprocedural
Technical success of the index procedure	Technical success of the index procedure	Perioperative/Periprocedural
Conversion to another access	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 2, 2026
• First Submitted That Met QC Criteria: July 2, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

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

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