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Starting soon Not applicable

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

NCT05868564 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2023-07-01
Last updated
2023-05-22

Condition(s) studied

Peripheral Arterial Disease

Investigational drug(s) / intervention(s)

Atherectomy+Drug-coated balloonDrug-coated balloon

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

Trial sites (1)

FacilityCityRegionStatus
Renji Hospital Shanghai Shanghai Municipality
Official registry record

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.

View NCT05868564 on ClinicalTrials.gov ↗ ← All trials in China