Atherectomy Followed With a Drug Coated Balloon in the Treatment of Long Femoropopliteal Lesions (NCT05868564) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Atherectomy Followed With a Drug Coated Balloon in the Treatment of Long Femoropopliteal Lesions
China100 participantsStarted 2023-07-01
Plain-language summary
The study is a prospective, multicenter, randomized pilot study to evaluate the clinical outcome of the plaque atherectomy system followed by the UltrafreeTM drug coated balloon catheter versus the drug coated balloon in patients with chronic long femoropopliteal lesions.
Who can participate
Age range18 Years – 85 Years
SexALL
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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