MOTIV BTK Randomized Controlled Trial

Who can take part

• 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

Who cannot take part

• 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 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 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 a known allergy or sensitivity to contrast media that cannot be adequately pre-treated
• 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) previously stented (in-stent restenotic lesion)
• Target vessel previously treated within 3 months prior to index procedure
• 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 non-atherosclerotic disease resulting in occlusion (e.g., embolism, Buerger's disease, vasculitis)
• 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
• Angiographic evidence of thromboembolism in target limb
• Subjects with renal failure (estimated Glomerular Filtration Rate [eGFR] < 30 ml/min)
• Clinical Exclusion Criteria
• Subjects will be excluded if any of the following criteria apply:
• Subject presents with CLI classified as Rutherford category 6
• Subject has a planned major amputation (of either leg)
• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
• 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 vessel(s) has any other significant lesions (≥50% diameter stenosis by visual assessment) that is not a target lesion
• Inflow-limiting arterial stenoses are unsuccessfully treated or left untreated