Sirolimus-coated balloon versus standard balloon for clogged leg arteries below the knee

Who can take part

• Age ≥ 21 years or minimum age
• Rutherford class 4 to 6 in the target limb; Intraoperative Inclusion Criteria
• Single or sequential de novo or re-stenotic lesions (stenosis of > 50% or occlusions) from 2 to 20cm in the proximal 200mm of below the knee arteries. Lesion is considered as one lesion if there is maximum of 30mm gap between lesions at discretion of investigator. Below the knee arteries are tibioperoneal trunk, anterior tibial artery, posterior tibial artery and peroneal artery
• Inflow free from flow limiting lesions (<50% stenosis) confirmed by duplex or angiography. Subjects with flow limiting inflow lesions (>50% stenosis) can be included if lesion had been treated successfully (<30% residual stenosis) before or during the index procedure
• Target vessel has angiographically documented run off to the foot after treatment (ie. without significant stenosis)

Who cannot take part

• Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet
• Prior bypass surgery of target vessel
• Previously implanted stent in the target lesion
• Use of DCBs, drug eluting stent, specialty balloons or artherectomy devices during the index procedure. (Non-compliant balloons are not considered specialty balloons)
• Comorbid conditions limiting life expectancy ≤ 1 year
• 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)
• Failure to obtain <30% residual stenosis in a pre-existing lesion
• Subject is pregnant or planning to become pregnant during the course of the study
• Heel gangrene
• Planned amputation of the target limb
• Vulnerable or protected adults
• Target vessel has lesions extending beyond the ankle joint
• Lesions requiring retrograde access (SAFARI)
• Highly calcified lesions (Contiguous calcification on both sides of the lesion)