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

NCT07803718 — Not applicable, Not yet recruiting, 60 participants, Sakarya University

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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

Registry	NCT07803718
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	60 (Estimated)
Sponsor	Sakarya University (Other)
Conditions	Peripheral Artery Disease, Atherectomy in Diseased Lower Extremity Arteries
Interventions	Rotational Atherectomy With Distal Embolic Protection and Drug-Coated Balloon Angioplasty (Device)
Dates	start 2026-09-01 (estimated), primary completion 2028-06-01 (estimated), completion 2028-09-01 (estimated), first posted 2026-09-04, last updated 2026-09-04
Locations	1 site in Turkey (Türkiye)

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Rotational Atherectomy With Drug-Coated Balloon and Embolic Protection	Experimental	Device: Rotational Atherectomy With Distal Embolic Protection and Drug-Coated Balloon Angioplasty	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.

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.

+Outcome measures

Primary outcomes

Primary Patency of the Treated Superficial Femoral Artery Segment at 12 Months [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

Primary Patency of the Treated Superficial Femoral Artery Segment at 1, 3, and 6 Months [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.
Target Lesion Revascularization [Through 12 months after the index procedure]: The proportion of participants requiring repeat endovascular or surgical revascularization of the treated SFA segment.
Periprocedural Distal Embolization [Periprocedural]: The proportion of participants with clinically evident or angiographically confirmed distal embolization associated with the index procedure.
Macroscopic Material Captured in the Distal Embolic Protection Filter [Immediately after the index procedure]: The proportion of retrieved distal embolic protection filters containing macroscopically visible thrombotic or atheromatous debris.
Technical Success of the Index Procedure [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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Sakarya Training and Research Hospital	Adapazarı, Sakarya	Turkey (Türkiye)