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NCT Number: NCT07803718

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

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.

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherectomy in Diseased Lower Extremity Arteries Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sakarya Training and Research Hospital

Adapazarı, Sakarya, 54100, Turkey (Türkiye)

Location contact

ÖMER FARUK TOPALOĞLU, MD

CONTACT

[email protected]

+90 264 888 4000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. Target Lesion Revascularization

    Time frame: Through 12 months after the index procedure

    The proportion of participants requiring repeat endovascular or surgical revascularization of the treated SFA segment.

  3. Periprocedural Distal Embolization

    Time frame: Periprocedural

    The proportion of participants with clinically evident or angiographically confirmed distal embolization associated with the index procedure.

  4. Macroscopic Material Captured in the Distal Embolic Protection Filter

    Time frame: Immediately after the index procedure

    The proportion of retrieved distal embolic protection filters containing macroscopically visible thrombotic or atheromatous debris.

  5. Technical Success of the Index Procedure

    Time frame: At the end 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.

Study contacts

Contact information is provided by the study sponsor or research team.

ÖMER FARUK TOPALOĞLU, MD

CONTACT

[email protected]

+90 264 888 40 00

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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