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Clearing a fully blocked thigh artery with a filter, rotating device and drug balloon

Tests a minimally invasive treatment for blocked thigh arteries in adults with peripheral artery disease.

Key facts

Who runs it
Sakarya University
Where
Türkiye1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
Rotational Atherectomy and Drug-Coated Balloon Angioplasty With Embolic Protection for Superficial Femoral Artery Occlusions
Status
Not yet recruiting
People taking part
60 people, planned
Started
1 Sept 2026
Expected to end
1 Sept 2028
Type of study
Interventional
Treatments tested
  • Rotational Atherectomy With Distal Embolic Protection and Drug-Coated Balloon Angioplasty
Record updated
4 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with peripheral artery disease whose main thigh artery (superficial femoral artery) is fully blocked and who need treatment from inside the artery.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Peripheral artery disease with symptoms, Rutherford category 2 to 5. Long-standing full blockage of the superficial femoral artery, from its start toward Hunter's canal. At least one open artery below the knee leading blood to the foot.

Main reasons for not taking part

  • Sudden loss of blood flow to the leg (acute limb ischemia)
  • Severe kidney problems that rule out iodine contrast dye
  • Blood clotting disorder
  • No open artery below the blockage carrying blood to the foot

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • Rotational Atherectomy With Drug-Coated Balloon and Embolic ProtectionTreatment being tested

    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.

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official 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
Plain-language title
Clearing a fully blocked thigh artery with a filter, rotating device and drug balloonGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
4 September 2026