Occlusion of the Femoral-popliteal SegmentATFANCT07694050
Choosing an Access for Endovascular Treatment of Femoral-popliteal Segment Occlusions
A study testing Brachial artery catheterization and Femoral artery catheterization in people with Occlusion of the Femoral-popliteal Segment and Femoral Access, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Occlusion of the Femoral-popliteal Segment, Femoral Access, Brachial Access
- What is being tested?
- Brachial artery catheterization and Femoral artery catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteRussia
- Study dates
- 1 Aug 2024to 18 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.)
- previous arterial access catheterizations.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Central Clinical Hospital of St. Alexy Metropolitan of Moscow of the Moscow Patriarchate of the Russian Orthodox Church, Moscow
Moscow, 117513
About this study
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.
Read the 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:
- The shoulder access has a lower number of complications compared to the femoral access
- The shoulder access has a lower number of complications requiring surgical intervention compared to the femoral access
- 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 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.
- Being tested
- Brachial artery catheterization, Femoral artery catheterization
- Keywords
- atherosclerosis of the arteries of the lower extremities, occlusion of the femoral-popliteal segment, endovascular treatment, femoral access, brachial access, access complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brachial artery catheterizationProcedure or surgery
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
Femoral artery catheterizationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Brachial | Active comparator | Brachial artery catheterization Receives: Procedure: Brachial artery catheterization |
| Femoral | Experimental | Femoral artery catheterization Receives: Procedure: Femoral artery catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematoma at the access point
Hematoma at the access point
Measured: Within 72 hours after artery catheterization
Acute artery occlusion
Acute artery occlusion
Measured: Within 72 hours after artery catheterization
Post-catheterization aneurysm that required surgery
Post-catheterization aneurysm that required surgery
Measured: Within 72 hours after radial artery catheterization
Technical success of access
Technical success of access
Measured: Perioperative/Periprocedural
Technical success of the index procedure
Technical success of the index procedure
Measured: Perioperative/Periprocedural
Conversion to another access
Conversion to another access
Measured: Perioperative/Periprocedural
Secondary outcomes (2)
Total number of complications
Total number of complications
Measured: Within 72 hours after radial artery catheterization
Total number of complications that required surgery
Total number of complications that required surgery
Measured: Within 72 hours after radial artery catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Aug 2024
- Primary completion15 Jun 2026
- Study completion18 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occlusion of the Femoral-popliteal SegmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandr V. Bocharov, PhD, MD, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694050
- Sponsor's protocol ID
- 261
- Acronym
- ATFA
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all personal data underlying the publication results
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choosing an Access for Endovascular Treatment of Femoral-popliteal Segment Occlusions
- ClinicalTrials.gov ID
- NCT07694050
- Acronym / sponsor ID
- ATFA / 261
- Keywords
- atherosclerosis of the arteries of the lower extremities, occlusion of the femoral-popliteal segment, endovascular treatment, femoral access, brachial access, access complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 18 Jun 2026 (actual)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- The shoulder access has a lower number of complications compared to the femoral access
- The shoulder access has a lower number of complications requiring surgical intervention compared to the femoral access
- 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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brachial | Active comparator | Procedure: Brachial artery catheterizationBrachial artery catheterization |
| Femoral | Experimental | Procedure: Femoral artery catheterizationFemoral artery catheterization |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.)
- previous arterial access catheterizations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brachial artery catheterizationThe 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 or surgery | Brachial |
| Femoral artery catheterizationThe 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 | Procedure or surgery | Femoral |
Primary outcome
Hematoma at the access point
Time frame: Within 72 hours after artery catheterization
Hematoma at the access point
Acute artery occlusion
Time frame: Within 72 hours after artery catheterization
Acute artery occlusion
Post-catheterization aneurysm that required surgery
Time frame: Within 72 hours after radial artery catheterization
Post-catheterization aneurysm that required surgery
Technical success of access
Time frame: Perioperative/Periprocedural
Technical success of access
Technical success of the index procedure
Time frame: Perioperative/Periprocedural
Technical success of the index procedure
Conversion to another access
Time frame: Perioperative/Periprocedural
Conversion to another access
2 secondary outcomes
Total number of complications
Time frame: Within 72 hours after radial artery catheterization
Total number of complications that required surgery
Time frame: Within 72 hours after radial artery catheterization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Yes. all personal data underlying the publication results
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brachial artery catheterization and Femoral artery catheterization in people with Occlusion of the Femoral-popliteal Segment and Femoral Access, run by Pirogov Russian National Research Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematoma at the access point (time frame: Within 72 hours after artery catheterization). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.