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
Among 22 studies in Peripheral Arterial Disease with a site in Turkey — 8 open to participants now, 10 under way, 2 of them phase 3. Peripheral Arterial Disease · Turkey.
Among the 22 studies in Peripheral Arterial Disease with a site in Turkey, this one is the 6th largest by planned enrollment of the 15 interventional ones that give a count, is one of 4 that started in 2026, is one of 10 with no phase, and was the 22nd registered.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
Browse Peripheral Arterial Disease studies →8 of the 22 studies in Peripheral Arterial Disease with a site in Turkey are open now. Recruiting first, the newest first:
Mersin Medicalpark Hastanesi · Sites in Turkey
Izmir Democracy University · Sites in Turkey
Gazi University · Sites in Turkey
CSL Behring · Sites in Turkey, United States, Argentina and 32 more countries
Saglik Bilimleri Universitesi · Sites in Turkey
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 192 Peripheral Arterial Disease studies recruiting now, 138 (72%) set no upper age limit and 9 (5%) stop at 75 or younger; 13 take children under 18; 19 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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22 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 1 · Phase 3 5
First in 2007; this study’s year is marked. 4 started in 2026.
This study's planned enrollment of 60 is below the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
Median enrollment 51 across the 15 interventional studies, 52 across the 7 observational. Of the 12 that completed or were terminated, 2 (17%) have results posted.
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5 of 22 have an industry lead sponsor. The 10 most frequent:
Sakarya University is the lead sponsor of 190 studies on the registry; 53 are open to participants now.
Sakarya University has 1 study filed under Peripheral Arterial Disease — fewer than ten, so there is no comparison to draw.
1 of the studies in Peripheral Arterial Disease with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07550959Biruni UniversityEvaluation of the Effectiveness of Hybrid Cardiac Rehabilitation in Peripheral Artery Disease | 2027-01-16 |
Among the 22 studies in Peripheral Arterial Disease with a site in Turkey, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jun 2028, 21 months later.
Of 260 non-industry interventional studies with no phase under Peripheral Arterial Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 64. This study's planned 21 months is below that.
Counting every sponsor, half of 385 studies reached it within 31 months; a quarter within 17 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
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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