Atherectomy Followed With a Drug Coated Balloon in the Treatment of Long Femoropopliteal Lesions
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Renji Hospital | Shanghai | Shanghai Municipality |
More RenJi Hospital trials in China
Other trials for the same condition
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