Clinical Trial TitleA Prospective, Multicenter, Single Blind, Randomized Controlled Trial Evaluating the Safety & Effectiveness of the MOTIV Sirolimus-Eluting Bioresorbable Vascular Scaffold Compared with Plain Balloon Angioplasty for the Treatment of Infrapopliteal Lesions
National Clinical Trial Number:NCT05406622
Clinical Trial Protocol Description:
This study is using the REVA MOTIV Sirolimus-Eluting Bioresorbable Scaffold indicated for patients with Rutherford category 4 or 5 CLI due to infrapopliteal artery disease suitable for endovascular intervention to determine the safety and efficacy of improving arterial luminal diameter. This study is randomized 1:1 with intervention and control standard of care group. Study duration will be approximately 4 to 5 years post procedure.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Present with Rutherford category 4 or 5.
- Have significant stenosis per angiogram.
You will be excluded from the study if any of the following criteria apply to you:
- Have severe medical comorbidities. (i.e., history of stroke within 3 months, history of MI within 30 days, renal failure)
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.