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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

This is a multicenter, prospective, randomized, controlled comparison study. A total of 100 subjects will be enrolled into this study and will be randomized on a 1:1 basis to either drug coated balloon angioplasty combined with atherectomy or drug coated balloon angioplasty for subjects with long de-nove or restenosis femoropopliteal lesions( Stenotic lesion>15cm or Chronic total occlusion between 6-15cm). Angiographic patterns of the target lesion, including lesion length, calcification grade, and minimal lumen diameter (MLD) prior to and after the intervention, ultrasound images of the target lesion at 12-month follow-up will be independently adjudicated by an independent angiographic and ultrasound core lab. The primary endpoint is primary patency at 12 months based on Kaplan-Meier survival analysis. Follow-up visits are scheduled at 1,3,6,12,24 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05868564
Study type Interventional
Source RenJi Hospital
Contact Ni Qihong, M.D.
Phone +8615801900772
Email niqihong1989@163.com
Status Not yet recruiting
Phase N/A
Start date July 1, 2023
Completion date July 31, 2027
View Details
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