NCT05556681

Study of BD Sirolimus Drug Coated Catheter for Treatment of Femoropopliteal Arteries

Prospective, Multicenter, Single Arm, Non-Randomized Study of BD Sirolimus Drug Coated Catheter for Treatment of Femoropopliteal Arteries

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

The objective of this early feasibility study is to assess the safety and performance of the BD™ Sirolimus Drug Coated Balloon Catheter.

Detailed description

This is a prospective, multi-center, non-randomized, single-arm early feasibility study designed to assess the safety and performance of the BD™ Sirolimus Drug Coated Balloon Catheter for the treatment of stenosis in the femoropopliteal arteries. Follow-up for all treated subjects will be performed at post-procedure, 30 days, and 6, 12 months, 18 months and 24 months post-index procedure.

Conditions

• Peripheral Arterial Disease
• Peripheral Artery Disease
• Stenosis Artery

Interventions

Type	Name	Description
DEVICE	BD™ Sirolimus Drug Coated Balloon Catheter percutaneous transluminal angioplasty	The study will enroll patients presenting with clinical evidence of an angiographically significant lesion (Lesion ≥ 70% stenosis by visual estimate) in the femoropopliteal arteries. Eligible patients will undergo percutaneous transluminal angioplasty with the investigational BD™ Sirolimus Drug Coated Balloon Catheter.

Timeline

• Start date: 2022-08-02
• Primary completion: 2024-06-12
• Completion: 2025-11-24
• First posted: 2022-09-27
• Last updated: 2025-12-22

Locations

10 sites across 3 countries: Australia, New Zealand, Singapore

Regulatory

• FDA-regulated device study