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NOT YET RECRUITING
NCT05868564
NA

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

Sponsor: RenJi Hospital

View on ClinicalTrials.gov

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

Interventions

DEVICE

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

DEVICE

Drug-coated balloon

drug-coated balloon only in the active comparator group.

Locations (1)

Renji Hospital

Shanghai, Shanghai Municipality, China