Critical Limb Ischemia
Conditions
Brief summary
Pre-market clinical evaluation of the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for the planned treatment of infrapopliteal lesions.
Interventions
DEVICEMOTIV Sirolimus-Eluting Bioresorbable Scaffold
Participants will receive the MOTIV device
Participants will receive PTA treatment
Sponsors
REVA Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint: Composite of Limb Salvage and Primary Patency | 1 Year | 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. |
| Primary Safety Endpoint: Freedom from Major Adverse Limb Events (MALE) and All-Cause Peri-Operative Death (POD) | 30 Days | 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. |
Countries
Germany, United States
Contacts
PRINCIPAL_INVESTIGATOREhrin Armstrong, MD
ClinRe
PRINCIPAL_INVESTIGATORAndrej Schmidt, PD Dr.
University Leipzig
Outcome results
None listed