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

NAActive, not recruitingINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

August 2, 2022

Primary Completion Date

June 12, 2024

Study Completion Date

December 31, 2025

Conditions
Peripheral Arterial DiseasePeripheral Artery DiseaseStenosis Artery
Interventions
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.

Trial Locations (10)

1023

Auckland City Hospital, Grafton

2050

Royal Prince Alfred Hospital, Camperdown

2065

Royal North Shore Hospital, St Leonards

3004

The Alfred, Melbourne

3204

Waikato Hospital, Hamilton

4215

Gold Coast University Hospital, Southport

5001

Flinders University, Adelaide

6000

Royal Perth Hospital, Perth

308433

Tan Tock Seng Hospital, Novena

544886

Sengkang General Hospital, Punggol

Sponsors

Lead Sponsor

All Listed Sponsors
lead

C. R. Bard

INDUSTRY

NCT05556681 - Study of BD Sirolimus Drug Coated Catheter for Treatment of Femoropopliteal Arteries | Biotech Hunter | Biotech Hunter