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Critical Limb IschemiaNCT05406622

MOTIV BTK Randomized Controlled Trial

A study testing MOTIV Sirolimus-Eluting Bioresorbable Scaffold and Percutaneous Transluminal Angioplasty (PTA) Device in people with Critical Limb Ischemia, run by REVA Medical, Inc. at 26 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Pre-market clinical evaluation of the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for the planned treatment of infrapopliteal lesions. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Critical Limb Ischemia
What is being tested?
MOTIV Sirolimus-Eluting Bioresorbable Scaffold and Percutaneous Transluminal Angioplasty (PTA) Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
292 participants
Where
26 sitesin 2 countries
Study dates
10 Jun 2022to 31 Mar 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical Inclusion Criteria
  • Subjects must meet all of the following criteria to be eligible for enrollment in the trial:
  • Subject is at least 18 years of age.
  • Subject presents with symptomatic CLI classified as Rutherford category 4 or 5.
  • Subject agrees to comply with all-protocol specified procedures and follow-up assessments.
  • Subject or subject's legal representative signs an IRB/EC approved informed consent form prior to study participation.
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  • Angiographic Inclusion Criteria
  • Subjects must meet the following criteria to be eligible for participation in the study:
  • 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.
  • Target vessel diameter between 2.5 mm and 3.75 mm and able to be treated with the available device size matrix.
  • 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.
  • Total scaffold length among all target lesions must not exceed 120 mm (total sirolimus drug dose of 720 µg).
  • Target lesion(s) must be at least 4 cm above the ankle joint
  • Target lesion(s) are located in an area that may be stented without blocking access to patent main branches.
  • 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.
  • 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.
  • 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.

Who cannot join

  • Clinical Exclusion Criteria
  • Subjects will be excluded if any of the following criteria apply:
  • 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.
  • Subject has documented history of stroke within 3 months prior to the procedure.
  • Subject has history of MI, within 30 days prior to the planned index procedure.
  • Subjects with renal failure (estimated Glomerular Filtration Rate [eGFR] < 30 ml/min).
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  • Subject has non-atherosclerotic disease resulting in occlusion (e.g., embolism, Buerger's disease, vasculitis).
  • Subject presents with CLI classified as Rutherford category 6.
  • 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.
  • Subject had a major amputation that occurred less than one year prior to enrollment and subject is not independently ambulating.
  • Subject has a planned major amputation (of either leg).
  • Subject has had, or currently requires, surgical revascularization in the target vessel.
  • 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.
  • Subject has any systemic infection or immunocompromised state.
  • Subject has a coagulation disorder, including hypercoagulability; or the subject has contraindication to anticoagulant or antiplatelet therapy.
  • Subject has a known history of heparin-induced thrombocytopenia (HIT) type II.
  • Subject has known allergy or sensitivity to scaffold or scaffold components.
  • Subject has a known allergy or sensitivity to contrast media that cannot be adequately pre-treated.
  • Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
  • 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:
  • Target lesion(s) with severe calcification (PARC defined).
  • Target lesion(s) will be subjected to significant bending and axial compression.
  • Target lesion(s) located in highly tortuous vessels.
  • Target lesion(s) previously stented (in-stent restenotic lesion).
  • Target vessel(s) has any other significant lesions (≥50% diameter stenosis by visual assessment) that is not a target lesion.
  • Target vessel previously treated within 3 months prior to index procedure
  • Angiographic evidence of thromboembolism in target limb
  • Inflow-limiting arterial stenoses are unsuccessfully treated or left untreated

Trial locations and contacts

26 sites in 2 countries.

26 sites in 2 countries

United States25 sites

  • Pacific Vascular Institute

    ‘Aiea, Hawaii, 96701

  • Presbyterian Healthcare Services

    Albuquerque, New Mexico, 87106

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, 30369

  • UnityPoint Health Trinity Bettendorf Hospital

    Bettendorf, Iowa, 52722

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Vascular Care Connecticut

    Darien, Connecticut, 06820

  • Cardiovascular Medicine PC

    Davenport, Iowa, 52803

  • California Heart and Vascular Clinic

    El Centro, California, 92243

  • Mission Cardiovascular Research Institute

    Fremont, California, 94538

  • Bellin Memorial Hospital

    Green Bay, Wisconsin, 54301

  • Cardiovascular Institute of the South

    Houma, Louisiana, 98374

  • First Coast Cardiovascular Institute

    Jacksonville, Florida, 32256

  • Ballad Health System

    Kingsport, Tennessee, 37660

  • Texas Tech University

    Lubbock, Texas, 79430

  • North Dallas Research Associates

    McKinney, Texas, 75069

  • Miami Cardiac & Vascular Institute

    Miami, Florida, 33176

  • Palm Vascular

    Miami Beach, Florida, 33140

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • Baylor Research Institute

    Plano, Texas, 75093

  • Adventist Health

    St. Helena, California, 94574

  • Stanford University Medical Center

    Stanford, California, 94304

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

  • ClinRe

    Thornton, Colorado, 80023

  • The Vascular Care Group - Wellesley

    Wellesley, Massachusetts, 02482

Other trials in United States

Germany1 site

  • University Leipzig

    Leipzig, Leipzig, 04109

Other trials in Germany

About this study

Official title: A Prospective, Multicenter, Single Blind, Randomized Controlled Trial Evaluating the Safety and Effectiveness of the MOTIV Sirolimus-Eluting Bioresorbable Vascular Scaffold Compared With Plain Balloon Angioplasty for the Treatment of Infrapopliteal Lesions

Pre-market clinical evaluation of the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for the planned treatment of infrapopliteal lesions.

Being tested
MOTIV Sirolimus-Eluting Bioresorbable Scaffold, Percutaneous Transluminal Angioplasty (PTA) Device
Medical subject headings
Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MOTIV Sirolimus-Eluting Bioresorbable ScaffoldDevice

    Participants will receive the MOTIV device

  • Percutaneous Transluminal Angioplasty (PTA) DeviceDevice

    Participants will receive PTA treatment

Study groups in NCT05406622
Study groupRoleWhat they receive
MOTIV Sirolimus-Eluting Bioresorbable ScaffoldExperimentalParticipants who receive the MOTIV device will be included in this arm
Receives: Device: MOTIV Sirolimus-Eluting Bioresorbable Scaffold
Percutaneous Transluminal Angioplasty (PTA)Active comparatorParticipants who receive PTA treatment will be included in this arm
Receives: Device: Percutaneous Transluminal Angioplasty (PTA) Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Efficacy Endpoint: Composite of Limb Salvage and Primary Patency

    Freedom from the composite of above-the-ankle amputation, target lesion occlusion, clinically driven target lesion revascularization (CD-TLR), and binary restenosis of the target lesion.

    Measured: 1 Year

  2. Primary Safety Endpoint: Freedom from Major Adverse Limb Events (MALE) and All-Cause Peri-Operative Death (POD)

    Freedom from the composite of all-cause death, above-the-ankle amputation, or major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving the infrapopliteal arteries.

    Measured: 30 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2022
  2. Study start10 Jun 2022
  3. Primary completion30 Apr 2026
  4. Study completion31 Mar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
292 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05406622
Sponsor's protocol ID
HCT6800
Status last verified
Jun 2026
First submitted
31 May 2022
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing MOTIV Sirolimus-Eluting Bioresorbable Scaffold and Percutaneous Transluminal Angioplasty (PTA) Device in people with Critical Limb Ischemia, run by REVA Medical, Inc. at 26 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Efficacy Endpoint: Composite of Limb Salvage and Primary Patency (time frame: 1 Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05406622.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

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