Comorbid conditions limiting life expectancy ≤ 1 year

Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet

Subject is pregnant or planning to become pregnant during the course of the study

Heel gangrene

Prior bypass surgery of target vessel

Planned amputation of the target limb

Previously implanted stent in the target lesion

Vulnerable or protected adults

Bleeding diathesis or another disorder such as gastrointestinal ulceration which restrict the use of clopidogrel or aspirin

Known allergy to sirolimus

Intraoperative Exclusion Criteria

Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations).

Target vessel has lesions extending beyond the ankle joint

Failure to obtain <30% residual stenosis in a pre-existing lesion

Lesions requiring retrograde access (SAFARI)

Highly calcified lesions (Contiguous calcification on both sides of the lesion)

Use of DCBs, drug eluting stent, specialty balloons or artherectomy devices during the index procedure. (Non-compliant balloons are not considered specialty balloons)