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Atherectomy Followed With a Drug Coated Balloon in the Treatment of Long Femoropopliteal Lesions
Sponsor: RenJi Hospital
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.
Official title: Determination Of Effectiveness Of Directional Atherectomy Followed By A Paclitaxel- Coated Balloon For The Treatment Of Infrainguinal Vessels With Long Occlusive Femoropopliteal Lesions
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-07-01
Completion Date
2027-07-31
Last Updated
2023-05-22
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Renji Hospital
Shanghai, Shanghai Municipality, China