To evaluate the immediate and long-term safety and efficacy of the MOTIV™ Bioresorbable Scaffold in Below-The-Knee (BTK) arteries, for the treatment of patients with rest pain or minor tissue loss (CLTI).

The MOTIV Bioresorbable Scaffold incorporates a new scaffold material TyroCore, which is composed mainly of an iodinated, polycarbonate copolymer of tyrosine analogs. MOTIV is completely radiopaque and is comprised of thin struts that facilitate device delivery and precise target lesion treatment, and it is the first drug-eluting bioresorbable scaffold that received CE Mark approval for treatment of BTK peripheral artery disease. The MOTIV BTK study is a prospective, multi center pivotal trial enrolling patients with CLTI due to the presence of a target lesion of max 100mm in length in BTK arteries. Definition of a target lesion is a de novo or restenotic lesion after PTA or a residual flow-limiting dissection or restenosis after PTA of a longer lesion. Primary endpoints are primary patency rate through 12 months of follow-up as well as the proportion of subjects who experience serious device-related adverse events within 30 days. Secondary endpoints are freedom from clinical driven target leseion revascularization (CD-TLR), limb-salvage rate, clinical success, freedom from serious adverse events and technical success. Technical success was defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%.

Sixty patients were treated with 76 MOTIV scaffolds. Mean age was 77.1 years and the majority was male (85%). Mean lesion length was 29.46mm. The majority of lesions were de novo or restenotic after PTA (62%). Primary patency rate was 88.3% after 12 months and 81.7% after 24 months. Limb salvage rate was 95% at 2 years and freedom from CD-TLR was 98% at 12 months. Twelve deaths occurred during the 2 year follow-up period (21%) and were not device or procedure related.

The MOTIV BTK Study has demonstrated favorable acute safety and effectiveness performance in this initial physician-initiated trial. All patients in the study will be followed for a total of 36 months with both clinical and invasive imaging assessments.