Resoloy Initial Safety Evaluation

Inclusion criteria

Patient related

• Subject at least 18 years of age and provided written informed consent
• RF class 3, 4 or 5
• Subject requires treatment of up to 2 de novo or non-ISR restenotic lesions in BTK arteries
• Female subjects of childbearing potential must have a negative pregnancy test prior to treatment
• Presence of at least one patent (<50% DS) infrapopliteal vessel that has not been revascularized prior to index procedure

Lesion related

• Presence of elastic recoil or dissection type C-F requiring mechanical support after balloon angioplasty (diameter stenosis >30% by visual estimate)
• Lesion must be located in the native infrapopliteal vessels with reference vessel diameter of ≥2.5 and 4 mm (investigators assessment)
• Total lesion length/vessel length covered by BioFade scaffold should not exceed 27 mm
• Significant lesion (≥ 50% stenosis) in the inflow artery(ies) must be treated successfully (as per physician's assessment) through standard of care prior to the treatment of the target lesion. Treatment can be done within the same trial procedure.
• Distal margin of lesion must be located ≥10 cm above the proximal margin of the ankle mortise
• Non-target lesion, if any, must be located in separate infrapopliteal arteries and suitable to be treated per standard of care using PTA

Exclusion criteria

Patient related

• Prior amputation to the ipsilateral extremity other than the toe or forefoot or major amputation to the contralateral extremity <1 year prior index procedure
• Subject has known hypersensitivity or contraindication to device material and its degradants (that cannot be adequately premedicated)
• Subject has known allergic reaction, hypersensitivity or contraindication to aspirin, clopidogrel/prasugrel/ticagrelor and anti-coagulants
• Subject has known hypersensitivity or allergy to contrast media that cannon be medically managed
• Planned amputation on target leg other than toe or forefoot
• Systemic infection or infection within the target limb and/or immunocompromised
• Endovascular or surgical procedure on the target limb within 30 days prior index procedure (not including diagnostic procedures)
• Myocardial infarction within 30 days prior enrollment
• History of stroke within 90 days prior enrollment
• Patient is currently participating in another clinical study whose requirements conflict with or affect this clinical investigation
• Presence of any conditions that, in the investigator's opinion, could limit the participants ability to comply with the follow-up requirements, or impact the scientific soundness of the clinical investigation results
• Patient has subacute limb ischemia which requires thrombolysis as a treatment modality
• Patient has acute limb ischemia of the target limb
• Patient is bedridden or unable to walk (assistance is acceptable)
• Pregnant females or females of child-bearing potential without negative result of pregnancy test

Lesion related

• In-stent restenosis (metallic stent)
• Severe calcification (calcification renders the target lesion non-dilatable or has ≥5 cm of circumferential calcification)
• Evidence of thrombus in target vessel
• Evidence of thromboembolism or atheroembolism in the study leg
• No angiographic evidence of a patent pedal artery
• Aneurysm at treatment location
• Lesions/dissections exceeding 27 mm
• Visual hint of an additional significant stenosis (≥50%) in the target vessel prior index procedure