Atherectomy+Drug-coated balloon: Patients in experimental group will undergo endovascular treatment for femoropopliteal lesions. The lesion will be treated by atherectomy+drug-coated balloon in the experimental group
Drug-coated balloon: drug-coated balloon only in the active comparator group.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
1. Subject must be between 18 and 85 years old;
2. Chronic, symptomatic lower limb ischemia defined as Rutherford categories 3-5;
3. 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;
4. Patent distal popliteal artery and at least one patent distal runoff;
5. Willing to comply with the follow-up evaluation;
6. Written informed consent prior to any study procedures.
Exclusion Criteria:
1. Women during pregnancy and lactation, or patients with baby planning;
2. Life expectancy\<2 years;
3. Target lesion/vessel with in-stent restenosis
4. Target restenosis/vessel lesion previously treated with drug coated balloon or atherectomy \<12 months
5. Subjects s who are currently participating in other interventional drug or device trials;
6. Angiographic evidence of thrombus within the target vessel
7. Subjects have a history of stroke within 3 months;
8. Subjects have a history of myocardial infarction, thrombolytic therapy, or angina pectoris within 2 weeks;
9. Concomitant Renal failure with a serum creatinine\>2.0mg/dl; Subjects with known allergy to heparin, low molecular weight heparin, and contrast agents.
Primary outcome measure(s)
Peak Systolic Velocity Ratio (PSVR) — 12-month Peak Systolic Velocity Ratio (PSVR) of target lesion measured by ultrasound (PSVR ≤2.4 means primary patent of target lesion)
Freedom from major adverse limb events(MALEs) — 12-month Freedom from flow-limiting dissections (D-F), clinically-driven target vessel revascularization, major amputation, and all-cause of death
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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