An interventional study of Rotational Atherectomy With Distal Embolic Protection and Drug-Coated Balloon Angioplasty in Peripheral Artery Disease and Atherectomy in Diseased Lower Extremity Arteries, sponsored by Sakarya University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Sakarya University · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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
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 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.
Time frame: 12 months after the index procedure
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At the end of the index procedure
Plan to share: 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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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Sakarya University