Status:
RECRUITING
SirolimUs CoaTed Balloon for The TrEatment of Below The Knee Arterial Disease
Lead Sponsor:
Concept Medical Inc.
Conditions:
Peripheral Artery Disease
Atherosclerosis
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
The burden of limb loss as a result of peripheral arterial disease (PAD) is high and this problem is set to worsen globally. Treatment of PAD primarily involves revascularisation of the limb. Angiopla...
Eligibility Criteria
Inclusion
- Age ≥ 21 years or minimum age
- Rutherford class 4 to 6 in the target limb
- Intraoperative Inclusion Criteria
- Single or sequential de novo or re-stenotic lesions (stenosis of \> 50% or occlusions) from 2 to 20cm in the proximal 200mm of below the knee arteries. Lesion is considered as one lesion if there is maximum of 30mm gap between lesions at discretion of investigator. Below the knee arteries are tibioperoneal trunk, anterior tibial artery, posterior tibial artery and peroneal artery
- Inflow free from flow limiting lesions (\<50% stenosis) confirmed by duplex or angiography. Subjects with flow limiting inflow lesions (\>50% stenosis) can be included if lesion had been treated successfully (\<30% residual stenosis) before or during the index procedure.
- Target vessel has angiographically documented run off to the foot after treatment (ie. without significant stenosis)
Exclusion
- Comorbid conditions limiting life expectancy ≤ 1 year
- Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet
- Subject is pregnant or planning to become pregnant during the course of the study
- Heel gangrene
- Prior bypass surgery of target vessel
- Planned amputation of the target limb
- Previously implanted stent in the target lesion
- Vulnerable or protected adults
- Bleeding diathesis or another disorder such as gastrointestinal ulceration which restrict the use of clopidogrel or aspirin
- Known allergy to sirolimus
- Intraoperative Exclusion Criteria
- Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations).
- Target vessel has lesions extending beyond the ankle joint
- Failure to obtain \<30% residual stenosis in a pre-existing lesion
- Lesions requiring retrograde access (SAFARI)
- Highly calcified lesions (Contiguous calcification on both sides of the lesion)
- Use of DCBs, drug eluting stent, specialty balloons or artherectomy devices during the index procedure. (Non-compliant balloons are not considered specialty balloons)
Key Trial Info
Start Date :
August 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT04511247
Start Date
August 15 2020
End Date
December 1 2027
Last Update
July 3 2025
Active Locations (20)
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1
Khoo Teck Puat Hospital
Singapore, Singapore
2
National University Hospital
Singapore, Singapore
3
Ng Teng Fong General Hospital
Singapore, Singapore
4
Sengkang General Hospital
Singapore, Singapore