Status:
RECRUITING
MOTIV BTK Randomized Controlled Trial
Lead Sponsor:
REVA Medical, Inc.
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Pre-market clinical evaluation of the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for the planned treatment of infrapopliteal lesions.
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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).
- 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
Key Trial Info
Start Date :
June 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2029
Estimated Enrollment :
292 Patients enrolled
Trial Details
Trial ID
NCT05406622
Start Date
June 10 2022
End Date
March 31 2029
Last Update
April 2 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Adventist Health
St. Helena, California, United States, 94574
2
UnityPoint Health Trinity Bettendorf Hospital
Bettendorf, Iowa, United States, 52722
3
Cardiovascular Medicine PC
Davenport, Iowa, United States, 52803
4
University Leipzig
Leipzig, Germany, 04109