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New rotating catheter aims to unclog leg arteries without major surgery

NCT ID NCT07016698

Disease control Sponsor: C. R. Bard Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is tracking 600 people with peripheral artery disease (PAD) who are treated with the Rotarex device, a rotating catheter that cuts and removes plaque from blocked leg arteries. The goal is to see how well the device restores blood flow and how often serious complications occur within 30 days. Participants must have blockages in the leg arteries suitable for the device and be at least 22 years old.

What this could mean

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

Active substance
Rotarex rotational excisional atherectomy system (a device that cuts and removes plaque from leg arteries)
What this could lead to
If successful, this registry could confirm that the Rotarex device is a safe and effective option for restoring blood flow in leg arteries, helping people with peripheral artery disease avoid more invasive surgery.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove the device is better than other treatments. Results may not apply to all patients, and risks include artery damage, bleeding, or the need for repeat procedures.

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 600 people

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

Started

Sep 2025

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

22 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: 1. Subject or legally authorized representative provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the IRB for the site. 2. Subject is ≥22 years old at the time of signing the informed consent. 3. Subject must have a lesion(s) in their infra-inguinal peripheral arteries that can be treated with the RotarexTM Rotational Excisional Atherectomy System according to Instructions For Use (IFU). 4. Rutherford 2-5 for chronic limb ischemia and Rutherford I to IIb for acute limb ischemia. 5. Target lesion can be crossed intra-luminally by guidewire. 6. At least one patent native outflow artery to the foot, free from significant stenosis(≥50% stenosis as confirmed by angiography) (ChLI Cohort only, not applicable to ALI Cohort). Exclusion Criteria: 1. Subject is unable or unwilling to comply with follow-up procedures and visits. 2. Subject has a target lesion in a vessel with less than 3 mm in diameter. 3. Subject is participating in another device or drug clinical trial that interferes with this protocol and confounds results. 4. Treatment plan includes use of a thrombectomy and/or atherectomy device other than RotarexTM Rotational Excisional Atherectomy System. 5. Life expectancy is below 1 year. 6. Pregnant, planning to become pregnant during the course of the study or nursing a child.

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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.

Peripheral arterial disease(PAD)

How to take part

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

  1. The places running it

    2 sites. 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

  • Radiology and Imaging Specialists

    RECRUITING

    Lakeland, Florida, 33805, United States

  • Vital Heart and Vein

    RECRUITING

    Humble, Texas, 77338, United States

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