BOLT Lithotripsy RESTORE ATK Trial

Ki vehet részt

• Age of subject is ≥18
• Rutherford Clinical Category 2, 3, or 4
• Target lesion that is located in a native de novo superficial femoral artery (SFA) or popliteal artery (popliteal artery extends to and ends proximal to the ostium of the anterior tibial artery)
• Calcification is at least moderate. (presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending ≥ 50% the length of the lesion or absolute length ≥20mm

Ki nem vehet részt

• Significant stenosis (>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g., iliac or common femoral) not successfully treated with percutaneous angioplasty (PTA) or stent and without complications
• Planned major amputation of the target leg (above the ankle)
• The use of chronic total occlusion (CTO) re-entry devices
• CTOs greater than 80 mm in length
• Lesions within 10 mm of ostium of the SFA