IRB Study Number 23-184
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
The purpose of this study is to evaluate the safety and performance of the MOTIV scaffold (REVA Medical, LLC), a bioresorbable scaffold device coated with a biodegradable polymer which delivers a drug called Sirolimus. Sirolimus is widely used in stents and scaffolds to help prevent the treated vessel from re-closing. The scaffold with sirolimus is not approved by the Food and Drug Administration (FDA). The comparator device is PTA (Percutaneous Transluminal Angioplasty) with a standard balloon. Balloon angioplasty, the current standard of care for treatment of CLI, is a procedure that opens blocked vessels using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow can be restored. Then, the balloon is deflated, and the catheter is removed.
Inclusion Criteria
- 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 IRB approved informed consent form prior to study participation.
Exclusion Criteria
- 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.
- Subject had a major amputation that occurred less than one year prior to enrollment and subject is not independently ambulating.
- Subject has any systemic infection or immunocompromised state.
- 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.
