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New stent aims to open blocked leg arteries

NCT ID NCT02793492

Disease control Sponsor: Terumo Medical Corporation 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Updated 3 times

Summary

This study tests a self-expanding stent designed to open narrowed or blocked iliac arteries in the pelvis. About 75 people with moderate to severe leg pain or ulcers will receive the stent. Researchers will check for complications like death, amputation, or need for repeat treatment over 9 months.

What this could mean

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

Active substance
Misago RX self-expanding peripheral stent
What this could lead to
If successful, this stent could offer a safe and effective way to treat blocked iliac arteries, improving blood flow and reducing the need for repeat procedures.
What could go wrong
This is a small, single-arm study with no comparison group, so results may not apply broadly. Risks include stent-related complications like re-blockage or limb amputation.

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

75 people

The number who actually took part.

Started

Aug 2022

Finished

Jul 2026

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

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: 1. Is ≥ 18 years old and of legal consent. 2. Is willing to comply with all follow-up evaluations at the specified times. 3. Subject or subject's legal representative has been informed of and understands the nature of the study and provides signed informed consent to participate in the study. 4. Has a Rutherford Clinical Category Score of 2, 3 or 4. 5. Radiographic evidence of ≥ 50% stenosis or restenosis (from PTA or adjunct therapy, not including stents or stent grafts), or occlusion of target lesion(s) in the common iliac artery and/or external iliac artery. Exclusion Criteria: 1. Has had previous stent or stent-graft implantation in the target lesion(s). 2. Has a contraindication or known untreatable allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs or any other drug used during the study according to the protocol. 3. Has known hypersensitivity to contrast material that cannot be adequately pretreated. 4. Has known hypersensitivity to nickel-titanium (nitinol).

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As listed by the trial registrant

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

Iliac artery stenosis

Contacts and locations

Locations

  • Cardiovascular Institute of the South

    Lafayette, Louisiana, 70506, United States

  • ClinRe Inc. Advanced Heart and Vein Center

    Thornton, Colorado, 80023, United States

  • First Coast Cardiovascular Institute

    Jacksonville, Florida, 32256, United States

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666, United States

  • Novant Health

    Matthews, North Carolina, 28105, United States

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79430, United States

  • The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093, United States

  • University of Florida Health

    Gainesville, Florida, 32610, United States

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