Rotational Atherectomy and Drug-Coated Balloon Angioplasty With Embolic Protection for Superficial Femoral Artery Occlusions

NCT07803718 | Not Yet Recruiting

• 1 other identifier: SAU-SFA-CTO-2026-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Peripheral Artery Disease; Atherectomy in Diseased Lower Extremity Arteries

Keywords

Rotational Atherectomy; Distal Embolic Protection; Endovascular Revascularization

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months after the index procedure

Secondary Outcomes (5)

• Primary Patency of the Treated Superficial Femoral Artery Segment at 1, 3, and 6 Months

  1, 3, and 6 months after the index procedure

• Target Lesion Revascularization

  Through 12 months after the index procedure

• Periprocedural Distal Embolization

  Periprocedural

• Macroscopic Material Captured in the Distal Embolic Protection Filter

  Immediately after the index procedure

• Technical Success of the Index Procedure

  At the end of the index procedure

Study Arms (1)

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.

Device: Rotational Atherectomy With Distal Embolic Protection and Drug-Coated Balloon Angioplasty

Interventions

Rotational Atherectomy With Distal Embolic Protection and Drug-Coated Balloon Angioplasty DEVICE

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.

Rotational Atherectomy With Drug-Coated Balloon and Embolic Protection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Acute limb ischemia Severe renal impairment contraindicating iodinated contrast administration Coagulopathy Absence of a patent distal runoff artery

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya Training and Research Hospital

Adapazarı, Sakarya, 54100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Atherectomy, Coronary

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Atherectomy; Angioplasty; Catheterization; Therapeutics; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Percutaneous Coronary Intervention; Minimally Invasive Surgical Procedures; Thoracic Surgical Procedures; Investigative Techniques

Central Study Contacts

ÖMER FARUK TOPALOĞLU, MD

CONTACT

+90 264 888 40 00; ofaruktopaloglu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiology

Model Details: All participants will receive distal embolic protection, rotational atherectomy, and drug-coated balloon angioplasty.

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 4, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)