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MOTIV BTK Randomized Controlled Trial | Clinical Trials | Clareo Health

RECRUITINGNA

MOTIV BTK Randomized Controlled Trial

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

NCT05406622•REVA Medical, Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
•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 more criteria

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).
+18 more criteria

Locations (4)

Adventist Health

St. Helena, California, United States

UnityPoint Health Trinity Bettendorf Hospital

Bettendorf, Iowa, United States

Cardiovascular Medicine PC

Davenport, Iowa, United States

University Leipzig

Leipzig, Germany

Key Dates

Start Date

June 10, 2022

Primary Completion Date

September 30, 2025

Completion Date

March 31, 2029

Last Updated

April 2, 2025

Enrollment

292

ESTIMATED participants

Conditions

Critical Limb Ischemia

Interventions

MOTIV Sirolimus-Eluting Bioresorbable Scaffold

DEVICE

Percutaneous Transluminal Angioplasty (PTA) Device

DEVICE

Contacts

Danielle Gram

CONTACT

+1 (858) 966-3021 dgram@revamedical.com

Jeff Anderson

CONTACT

+1 (858) 966-3038 janderson@revamedical.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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MOTIV BTK Randomized Controlled Trial

Inclusion Criteria

Exclusion Criteria

Nutrition in Patient With Critical Limb Ischemia

Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease

Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention

miRNAs in Critical Limb Ischemia (miRNACLI)

FAZA PET/MRI in CLI Patients Pre and Post Revascularization

Additional Hyperbaric Oxygen After Lower Extremity Amputation