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
1 other identifier
interventional
292
2 countries
26
Brief Summary
Pre-market clinical evaluation of the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for the planned treatment of infrapopliteal lesions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2022
Longer than P75 for not_applicable
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2022
CompletedFirst Posted
Study publicly available on registry
June 6, 2022
CompletedStudy Start
First participant enrolled
June 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2030
ExpectedJune 18, 2026
June 1, 2026
3.9 years
May 31, 2022
June 16, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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.
1 Year
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.
30 Days
Study Arms (2)
MOTIV Sirolimus-Eluting Bioresorbable Scaffold
EXPERIMENTALParticipants who receive the MOTIV device will be included in this arm
Percutaneous Transluminal Angioplasty (PTA)
ACTIVE COMPARATORParticipants who receive PTA treatment will be included in this arm
Interventions
Participants will receive the MOTIV device
Participants will receive PTA treatment
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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).
- 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.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
California Heart and Vascular Clinic
El Centro, California, 92243, United States
Mission Cardiovascular Research Institute
Fremont, California, 94538, United States
Adventist Health
St. Helena, California, 94574, United States
Stanford University Medical Center
Stanford, California, 94304, United States
ClinRe
Thornton, Colorado, 80023, United States
Vascular Care Connecticut
Darien, Connecticut, 06820, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, 32256, United States
Miami Cardiac & Vascular Institute
Miami, Florida, 33176, United States
Palm Vascular
Miami Beach, Florida, 33140, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, 30369, United States
Pacific Vascular Institute
‘Aiea, Hawaii, 96701, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
UnityPoint Health Trinity Bettendorf Hospital
Bettendorf, Iowa, 52722, United States
Cardiovascular Medicine PC
Davenport, Iowa, 52803, United States
Cardiovascular Institute of the South
Houma, Louisiana, 98374, United States
The Vascular Care Group - Wellesley
Wellesley, Massachusetts, 02482, United States
Holy Name Medical Center
Teaneck, New Jersey, 07666, United States
Presbyterian Healthcare Services
Albuquerque, New Mexico, 87106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ballad Health System
Kingsport, Tennessee, 37660, United States
Texas Tech University
Lubbock, Texas, 79430, United States
North Dallas Research Associates
McKinney, Texas, 75069, United States
Baylor Research Institute
Plano, Texas, 75093, United States
Bellin Memorial Hospital
Green Bay, Wisconsin, 54301, United States
University Leipzig
Leipzig, Leipzig, 04109, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ehrin Armstrong, MD
ClinRe
- PRINCIPAL INVESTIGATOR
Andrej Schmidt, PD Dr.
University Leipzig
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2022
First Posted
June 6, 2022
Study Start
June 10, 2022
Primary Completion
April 30, 2026
Study Completion (Estimated)
March 31, 2030
Last Updated
June 18, 2026
Record last verified: 2026-06