Peripheral Artery DiseaseNCT07803718
Rotational Atherectomy and Drug-Coated Balloon Angioplasty With Embolic Protection for Superficial Femoral Artery Occlusions
A study testing Rotational Atherectomy With Distal Embolic Protection and Drug-Coated Balloon Angioplasty in people with Peripheral Artery Disease and Atherectomy in Diseased Lower Extremity Arteries, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Peripheral artery disease can reduce blood flow to the legs. In some patients, the superficial femoral artery, a major artery in the thigh, is completely blocked over a long segment. This study will evaluate a minimally invasive treatment for these blockages. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease, Atherectomy in Diseased Lower Extremity Arteries
- What is being tested?
- Rotational Atherectomy With Distal Embolic Protection and Drug-Coated Balloon Angioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older Symptomatic peripheral artery disease classified as Rutherford category 2 to 5 Chronic total occlusion of the superficial femoral artery extending from its origin toward Hunter's canal Clinical indication for endovascular treatment At least one patent distal runoff artery
Who cannot join
- Acute limb ischemia Severe renal impairment contraindicating iodinated contrast administration Coagulopathy Absence of a patent distal runoff artery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sakarya Training and Research Hospital
Adapazarı, Sakarya, 54100
ÖMER FARUK TOPALOĞLU, MD, +90 264 888 4000, ofaruktopaloglu@gmail.com
About this study
Official title: Prospective, Single-Center Evaluation of Rotational Atherectomy and Drug-Coated Balloon Angioplasty With Distal Embolic Protection for Chronic Total Occlusions of the Superficial Femoral Artery
Peripheral artery disease can reduce blood flow to the legs. In some patients, the superficial femoral artery, a major artery in the thigh, is completely blocked over a long segment. This study will evaluate a minimally invasive treatment for these blockages.
Approximately 60 adults who require endovascular treatment will undergo placement of a filter beyond the blockage to collect debris. Rotational atherectomy will then be used to remove part of the material causing the blockage, followed by drug-coated balloon angioplasty to widen the artery. A stent may be placed only if needed because of an inadequate treatment result or a procedure-related complication.
Participants will be evaluated by clinical examination and duplex ultrasound at 1, 3, 6, and 12 months. The main goal is to determine how often the treated artery remains open at 12 months. The study will also evaluate technical success, the need for repeat treatment, material captured by the filter, and procedure-related blockage of smaller downstream arteries.
- Being tested
- Rotational Atherectomy With Distal Embolic Protection and Drug-Coated Balloon Angioplasty
- Keywords
- Rotational Atherectomy, Distal Embolic Protection, Endovascular Revascularization
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotational Atherectomy With Distal Embolic Protection and Drug-Coated Balloon AngioplastyDevice
After successful crossing of the superficial femoral artery chronic total occlusion, a distal embolic protection filter will be deployed in the distal superficial femoral or popliteal artery. Rotational atherectomy will be performed to debulk atherosclerotic and thrombotic material, followed by drug-coated balloon angioplasty. Bailout stenting may be performed for flow-limiting dissection, significant residual stenosis, or another inadequate angiographic result.
| Study group | Role | What they receive |
|---|---|---|
| Rotational Atherectomy With Drug-Coated Balloon and Embolic Protection | Experimental | Participants will undergo placement of a distal embolic protection filter followed by rotational atherectomy and drug-coated balloon angioplasty for chronic total occlusion of the superficial femoral artery. Bailout stenting may be performed in cases of flow-limiting dissection, significant residual stenosis, or another inadequate angiographic result. Receives: Device: Rotational Atherectomy With Distal Embolic Protection and Drug-Coated Balloon Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patency of the Treated Superficial Femoral Artery Segment at 12 Months
The proportion of participants with a patent treated superficial femoral artery segment on duplex ultrasonography, defined as a peak systolic velocity ratio of less than 2.4.
Measured: 12 months after the index procedure
Secondary outcomes (5)
Primary Patency of the Treated Superficial Femoral Artery Segment at 1, 3, and 6 Months
The proportion of participants with a patent treated superficial femoral artery segment at each scheduled follow-up, assessed by duplex ultrasonography and defined as a peak systolic velocity ratio of less than 2.4.
Measured: 1, 3, and 6 months after the index procedure
Target Lesion Revascularization
The proportion of participants requiring repeat endovascular or surgical revascularization of the treated SFA segment.
Measured: Through 12 months after the index procedure
Periprocedural Distal Embolization
The proportion of participants with clinically evident or angiographically confirmed distal embolization associated with the index procedure.
Measured: Periprocedural
Macroscopic Material Captured in the Distal Embolic Protection Filter
The proportion of retrieved distal embolic protection filters containing macroscopically visible thrombotic or atheromatous debris.
Measured: Immediately after the index procedure
Technical Success of the Index Procedure
The proportion of procedures in which the target lesion is successfully crossed and treated with rotational atherectomy and drug-coated balloon angioplasty, with restoration of antegrade flow on final angiography.
Measured: At the end of the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive distal embolic protection, rotational atherectomy, and drug-coated balloon angioplasty.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ömer faruk topaloglu, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803718
- Sponsor's protocol ID
- SAU-SFA-CTO-2026-01
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. De-identified aggregate study results will be reported in scientific publications; however, no formal data-sharing repository or data-access mechanism has been established for this investigator-initiated, single-center study.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-Center Evaluation of Rotational Atherectomy and Drug-Coated Balloon Angioplasty With Distal Embolic Protection for Chronic Total Occlusions of the Superficial Femoral Artery
- ClinicalTrials.gov ID
- NCT07803718
- Acronym / sponsor ID
- SAU-SFA-CTO-2026-01
- Keywords
- Rotational Atherectomy, Distal Embolic Protection, Endovascular Revascularization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 4 Sep 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.
Peripheral artery disease can reduce blood flow to the legs. In some patients, the superficial femoral artery, a major artery in the thigh, is completely blocked over a long segment. This study will evaluate a minimally invasive treatment for these blockages.
Approximately 60 adults who require endovascular treatment will undergo placement of a filter beyond the blockage to collect debris. Rotational atherectomy will then be used to remove part of the material causing the blockage, followed by drug-coated balloon angioplasty to widen the artery. A stent may be placed only if needed because of an inadequate treatment result or a procedure-related complication.
Participants will be evaluated by clinical examination and duplex ultrasound at 1, 3, 6, and 12 months. The main goal is to determine how often the treated artery remains open at 12 months. The study will also evaluate technical success, the need for repeat treatment, material captured by the filter, and procedure-related blockage of smaller downstream arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive distal embolic protection, rotational atherectomy, and drug-coated balloon angioplasty.
| Arm | Type | Receives |
|---|---|---|
| Rotational Atherectomy With Drug-Coated Balloon and Embolic Protection | Experimental | Device: Rotational Atherectomy With Distal Embolic Protection and Drug-Coated Balloon AngioplastyParticipants will undergo placement of a distal embolic protection filter followed by rotational atherectomy and drug-coated balloon angioplasty for chronic total occlusion of the superficial femoral artery. Bailout stenting may be performed in cases of flow-limiting dissection, significant residual stenosis, or another inadequate angiographic result. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 years or older Symptomatic peripheral artery disease classified as Rutherford category 2 to 5 Chronic total occlusion of the superficial femoral artery extending from its origin toward Hunter's canal Clinical indication for endovascular treatment At least one patent distal runoff artery
Key exclusion criteria (1 listed)
- Acute limb ischemia Severe renal impairment contraindicating iodinated contrast administration Coagulopathy Absence of a patent distal runoff artery
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 |
|---|---|---|
| Rotational Atherectomy With Distal Embolic Protection and Drug-Coated Balloon AngioplastyAfter successful crossing of the superficial femoral artery chronic total occlusion, a distal embolic protection filter will be deployed in the distal superficial femoral or popliteal artery. Rotational atherectomy will be performed to debulk atherosclerotic and thrombotic material, followed by drug-coated balloon angioplasty. Bailout stenting may be performed for flow-limiting dissection, significant residual stenosis, or another inadequate angiographic result. | Device | Rotational Atherectomy With Drug-Coated Balloon and Embolic Protection |
Primary outcome
Primary Patency of the Treated Superficial Femoral Artery Segment at 12 Months
Time frame: 12 months after the index procedure
The proportion of participants with a patent treated superficial femoral artery segment on duplex ultrasonography, defined as a peak systolic velocity ratio of less than 2.4.
5 secondary outcomes
Primary Patency of the Treated Superficial Femoral Artery Segment at 1, 3, and 6 Months
Time frame: 1, 3, and 6 months after the index procedure
Target Lesion Revascularization
Time frame: Through 12 months after the index procedure
Periprocedural Distal Embolization
Time frame: Periprocedural
Macroscopic Material Captured in the Distal Embolic Protection Filter
Time frame: Immediately after the index procedure
Technical Success of the Index Procedure
Time frame: At the end of the index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. De-identified aggregate study results will be reported in scientific publications; however, no formal data-sharing repository or data-access mechanism has been established for this investigator-initiated, single-center study.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotational Atherectomy With Distal Embolic Protection and Drug-Coated Balloon Angioplasty in people with Peripheral Artery Disease and Atherectomy in Diseased Lower Extremity Arteries, run by Sakarya University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 4 Sep 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ÖMER FARUK TOPALOĞLU, MD (+90 264 888 40 00, ofaruktopaloglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Patency of the Treated Superficial Femoral Artery Segment at 12 Months (time frame: 12 months after the index procedure). 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 4 Sep 2026.