Atherectomy Followed With a Drug Coated Balloon in the Treatment of Long Femoropopliteal Lesions

This is a multicenter, prospective, randomized, controlled comparison study. A total of 100 subjects will be enrolled into this study and will be randomized on a 1:1 basis to either drug coated balloon angioplasty combined with atherectomy or drug coated balloon angioplasty for subjects with long de-nove or restenosis femoropopliteal lesions( Stenotic lesion>15cm or Chronic total occlusion between 6-15cm). Angiographic patterns of the target lesion, including lesion length, calcification grade, and minimal lumen diameter (MLD) prior to and after the intervention, ultrasound images of the target lesion at 12-month follow-up will be independently adjudicated by an independent angiographic and ultrasound core lab. The primary endpoint is primary patency at 12 months based on Kaplan-Meier survival analysis. Follow-up visits are scheduled at 1,3,6,12,24 months.

Inclusion criteria

• Subject must be between 18 and 85 years old;
• Chronic, symptomatic lower limb ischemia defined as Rutherford categories 3-5;
• Stenotic, restenosis, or occlusive lesions in the native femoropopliteal artery which meets all of the following criteria: Stenotic lesion(>70% diameter stenosis) >15cm or Chronic total occlusion between 6-15cm; Target vessel is 3.0 to 7.0 mm in diameter (visual estimate); Guidewire must be across the target lesion within the true lumen before study randomization;
• Patent distal popliteal artery and at least one patent distal runoff;
• Willing to comply with the follow-up evaluation;
• Written informed consent prior to any study procedures.

Exclusion criteria

• Women during pregnancy and lactation, or patients with baby planning;
• Life expectancy<2 years;
• Target lesion/vessel with in-stent restenosis
• Target restenosis/vessel lesion previously treated with drug coated balloon or atherectomy <12 months
• Subjects s who are currently participating in other interventional drug or device trials;
• Angiographic evidence of thrombus within the target vessel
• Subjects have a history of stroke within 3 months;
• Subjects have a history of myocardial infarction, thrombolytic therapy, or angina pectoris within 2 weeks;
• Concomitant Renal failure with a serum creatinine>2.0mg/dl; Subjects with known allergy to heparin, low molecular weight heparin, and contrast agents.