MOTIV BTK Randomized Controlled Trial

Inclusion criteria

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 criteria

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