Actively Recruiting
Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease
Led by Concept Medical Inc. · Updated on 2025-07-03
279
Participants Needed
20
Research Sites
325 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to conduct a randomized, double blind, randomised controlled multicentre trial of sirolimus drug coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial and popliteal arterial disease.
CONDITIONS
Official Title
Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years or older
- Rutherford class 3 to 6 in the target limb
- Single or sequential de novo or re-stenotic lesions (stenosis > 50% or occlusions) from 2 to 20 cm in the femoropopliteal arteries
- Inflow free from flow limiting lesions (<50% stenosis) or successfully treated prior to or during procedure
- At least one non-occluded crural vessel with angiographically documented runoff to the foot
You will not qualify if you...
- Life expectancy less than or equal to 1 year due to other conditions
- Currently participating in another investigational drug or device study without reaching first primary endpoint
- Pregnant or planning pregnancy during the study
- Heel gangrene
- Prior bypass surgery of the target vessel
- Planned amputation of the target limb
- Previously implanted stent in the target lesion
- Vulnerable or protected adults
- Bleeding disorders or conditions restricting use of clopidogrel or aspirin
- Known allergy to sirolimus
- Failure to cross the target lesion with a guide wire
- Failure to achieve less than 30% residual stenosis in a pre-existing lesion
- Highly calcific lesions
- Use of DCBs, drug eluting stent, specialty balloons or atherectomy devices during the procedure
- Lesions requiring retrograde access (SAFARI)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Khoo Teck Puat Hospital
Singapore, Singapore
Actively Recruiting
2
National University Hospital
Singapore, Singapore
Actively Recruiting
3
Ng Teng Fong General Hospital
Singapore, Singapore
Not Yet Recruiting
4
Sengkang General Hospital
Singapore, Singapore
Actively Recruiting
5
Singapore General Hospital
Singapore, Singapore
Actively Recruiting
6
Tan Tock Seng Hospital
Singapore, Singapore
Actively Recruiting
7
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
8
Kaoshiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
9
Far Eastern Memorial Hospital
New Taipei City, Taiwan
Actively Recruiting
10
Taipei Tzuchi Hospital
New Taipei City, Taiwan
Actively Recruiting
11
China Medical University Hospital
Taichung, Taiwan
Not Yet Recruiting
12
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
13
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
Actively Recruiting
14
Linkou Chang Gung Memorial Hospital
Taoyuan City, Taiwan
Actively Recruiting
15
Phramongkutklao Hospital
Bangkok, Thailand
Actively Recruiting
16
Rajavithi Hospital
Bangkok, Thailand
Actively Recruiting
17
Ramathibodi Hospital
Bangkok, Thailand
Not Yet Recruiting
18
Siriraj Hospital
Bangkok, Thailand
Actively Recruiting
19
Vajira Hospital
Bangkok, Thailand
Actively Recruiting
20
Thammasat University Hospital
Pathum Thani, Thailand
Actively Recruiting
Research Team
E
Edward Choke
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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