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Can a rotating device plus a debris filter keep leg arteries open longer?

NCT ID NCT07803718

Disease control Sponsor: Sakarya University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

Peripheral artery disease can completely block the superficial femoral artery in the thigh, cutting off blood flow to the leg. This trial tests a minimally invasive procedure that uses a rotating device to shave away the blockage, followed by a drug-coated balloon to widen the artery. A small filter placed beyond the blockage catches any debris that breaks loose. Researchers will follow about 60 adults for 12 months to see how often the treated artery stays open.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rotational atherectomy with distal embolic protection and drug-coated balloon angioplasty
What this could lead to
If it works, this approach could offer a more durable, minimally invasive option for people with completely blocked thigh arteries, reducing the need for repeat procedures.
What could go wrong
This is a single-center study with 60 participants, so results may not apply broadly. The procedure carries risks like artery damage, debris embolization, or the need for bailout stenting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atherectomy in diseased lower extremity arteries Peripheral artery disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sakarya Training and Research Hospital

    Adapazarı, Sakarya, 54100, Turkey (Türkiye)

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