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New dissolving scaffold could save legs from amputation

NCT ID NCT05406622

Disease control Sponsor: REVA Medical, Inc. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new device called the MOTIV Sirolimus-Eluting Bioresorbable Vascular Scaffold for people with severe leg artery disease (critical limb ischemia). The scaffold slowly releases medicine to keep the artery open and then dissolves over time. Researchers compare it to standard balloon angioplasty in 292 adults to see if it better prevents amputation, re-blockage, 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 292 people

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

Started

Jun 2022

Expected to finish

Mar 2030

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

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: Clinical Inclusion Criteria Subjects must meet all of the following criteria to be eligible for enrollment in the trial: 1. Subject is at least 18 years of age. 2. Subject presents with symptomatic CLI classified as Rutherford category 4 or 5. 3. Subject agrees to comply with all-protocol specified procedures and follow-up assessments. 4. Subject or subject's legal representative signs an IRB/EC approved informed consent form prior to study participation. Angiographic Inclusion Criteria Subjects must meet the following criteria to be eligible for participation in the study: 1. Significant stenosis (\>70% diameter stenosis by visual estimate) of one or two native infrapopliteal lesions; if two lesions, each lesion should be in a separate infrapopliteal vessel in the same limb. Unstented restenotic lesions are permitted. 2. Target vessel diameter between 2.5 mm and 3.75 mm and able to be treated with the available device size matrix. 3. Each target lesion is treatable by a maximum of 3 scaffolds, and all target lesions(s) combined must be treatable by a maximum of 4 scaffolds. 4. Total scaffold length among all target lesions must not exceed 120 mm (total sirolimus drug dose of 720 µg). 5. Target lesion(s) must be at least 4 cm above the ankle joint 6. Target lesion(s) are located in an area that may be stented without blocking access to patent main branches. 7. A patent inflow artery from the aorta to the target lesion free from significant stenosis (≥50% diameter stenosis by visual estimate) must be present, as confirmed by angiography. 8. Significant lesions (≥50% diameter stenosis) in inflow arteries must be treated successfully (per physician's assessment) using standard of care treatment prior to enrollment; inflow lesion treatment may be performed during the index procedure. 9. Target vessel(s) reconstitute(s) at or above the ankle or displays normal terminal branching with inline flow to at least one patent (\<50% diameter stenosis by visual assessment) outflow vessel. Exclusion Criteria: Clinical Exclusion Criteria Subjects will be excluded if any of the following criteria apply: 1. Subject has severe medical comorbidities or other medical, social or psychological condition that could limit subject's ability to participate in the study or is associated with a life expectancy of less than 1 year. 2. Subject has documented history of stroke within 3 months prior to the procedure. 3. Subject has history of MI, within 30 days prior to the planned index procedure. 4. Subjects with renal failure (estimated Glomerular Filtration Rate \[eGFR\] \< 30 ml/min). 5. Subject has non-atherosclerotic disease resulting in occlusion (e.g., embolism, Buerger's disease, vasculitis). 6. Subject presents with CLI classified as Rutherford category 6. 7. Subject has acute limb ischemia, defined as symptom onset occurring less than 14 days prior to the index procedure with associated loss of sensation or motor function. 8. Subject had a major amputation that occurred less than one year prior to enrollment and subject is not independently ambulating. 9. Subject has a planned major amputation (of either leg). 10. Subject has had, or currently requires, surgical revascularization in the target vessel. 11. Subject has a planned use of adjunctive primary treatment modalities (e.g., radiation therapy, stents) in below-the-knee vessels; plaque modification technology such as the use of atherectomy, laser or cutting balloons is permitted. 12. Subject has any systemic infection or immunocompromised state. 13. Subject has a coagulation disorder, including hypercoagulability; or the subject has contraindication to anticoagulant or antiplatelet therapy. 14. Subject has a known history of heparin-induced thrombocytopenia (HIT) type II. 15. Subject has known allergy or sensitivity to scaffold or scaffold components. 16. Subject has a known allergy or sensitivity to contrast media that cannot be adequately pre-treated. 17. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. 18. Subject is currently participating in another investigational drug or device clinical study that has not yet met its primary endpoint. Angiographic Exclusion Criteria Subjects will be excluded if any of the following criteria apply: 1. Target lesion(s) with severe calcification (PARC defined). 2. Target lesion(s) will be subjected to significant bending and axial compression. 3. Target lesion(s) located in highly tortuous vessels. 4. Target lesion(s) previously stented (in-stent restenotic lesion). 5. Target vessel(s) has any other significant lesions (≥50% diameter stenosis by visual assessment) that is not a target lesion. 6. Target vessel previously treated within 3 months prior to index procedure 7. Angiographic evidence of thromboembolism in target limb 8. Inflow-limiting arterial stenoses are unsuccessfully treated or left untreated

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Conditions

The condition(s) this trial relates to.

Chronic Limb-Threatening Ischemia limb ischemia

As listed by the trial registrant

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

Critical limb ischemia

Contacts and locations

Locations

  • Adventist Health

    St. Helena, California, 94574, United States

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453, United States

  • Ballad Health System

    Kingsport, Tennessee, 37660, United States

  • Baylor Research Institute

    Plano, Texas, 75093, United States

  • Bellin Memorial Hospital

    Green Bay, Wisconsin, 54301, United States

  • California Heart and Vascular Clinic

    El Centro, California, 92243, United States

  • Cardiovascular Institute of the South

    Houma, Louisiana, 98374, United States

  • Cardiovascular Medicine PC

    Davenport, Iowa, 52803, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • ClinRe

    Thornton, Colorado, 80023, United States

  • First Coast Cardiovascular Institute

    Jacksonville, Florida, 32256, United States

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666, United States

  • Miami Cardiac & Vascular Institute

    Miami, Florida, 33176, United States

  • Mission Cardiovascular Research Institute

    Fremont, California, 94538, United States

  • North Dallas Research Associates

    McKinney, Texas, 75069, United States

  • Pacific Vascular Institute

    ‘Aiea, Hawaii, 96701, United States

  • Palm Vascular

    Miami Beach, Florida, 33140, United States

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, 30369, United States

  • Presbyterian Healthcare Services

    Albuquerque, New Mexico, 87106, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Stanford University Medical Center

    Stanford, California, 94304, United States

  • Texas Tech University

    Lubbock, Texas, 79430, United States

  • The Vascular Care Group - Wellesley

    Wellesley, Massachusetts, 02482, United States

  • UnityPoint Health Trinity Bettendorf Hospital

    Bettendorf, Iowa, 52722, United States

  • University Leipzig

    Leipzig, Leipzig, 04109, Germany

  • Vascular Care Connecticut

    Darien, Connecticut, 06820, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.