Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions

Inclusion Criteria

• •Subject age ≥ 18
• •Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved inform consent form
• •Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing
• •Rutherford Classification 2-5
• •Subject has a de novo or restenotic lesion in SFA and/or PPA not exceeding the medial femoral epicondyle with ≥ 70% stenosis documented angiographically
• •No previous stent in the target lesion, if target vessel was previously stented the stent should be at least 3cm apart
• •Target lesion length is ≥ 10cm, no maximum lesion length limit
• •Severe calcification on fluoroscopy defined by PACSS Grade 4: 1) bilateral calcification and 2) extending ≥50mm in length
• •Multiple lesions with max. 3cm healthy vessel segment in between lesions can be considered at the discretion of the operator as one lesion
• •Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation
• •Patency of at least one infrapopliteal artery to the ankle (\< 50% diameter stenosis) in continuity with the native femoropopliteal artery
• •A guidewire has successfully traversed the target treatment segment (both intraluminal and subintimal crossing allowed)