BOLT Lithotripsy RESTORE BTK Trial

Ki vehet részt

• Age of subject is ≥18
• Rutherford Clinical Category 2 - 5
• Single or multiple target lesion(s) is/are located in a de novo artery distal to the trifurcation vessels and extends to and ends above the ankle
• 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 (e.g., iliac or common femoral) not successfully treated with PTA, stent or Lithotripsy and without complications
• Previously implanted stent in the treatment lesion
• Target lesion is within only lower extremity vessel with < 50% stenosis
• Planned major amputation of the target leg