SirolimUs CoaTed Balloon for The TrEatment of Below The Knee Arterial Disease

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Peripheral Artery Disease, Atherosclerosis, Arterial Disease of Legs

In brief

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 below the knee arterial disease.

Key facts

Study ID

NCT04511247

Run by

Concept Medical Inc.

People needed

219

Starts

2020-08-15

Expected to finish

2027-12-01

Last updated by the study team

2025-07-03

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Khoo Teck Puat Hospital — Singapore, Singapore (enrolling)
• National University Hospital — Singapore, Singapore (enrolling)
• Siriraj Hospital — Bangkok, Thailand (enrolling)
• Vajira Hospital — Bangkok, Thailand (enrolling)
• Thammasat University Hospital — Pathum Thani, Thailand (enrolling)
• Sengkang General Hospital — Singapore, Singapore (enrolling)
• Singapore General Hospital — Singapore, Singapore (enrolling)
• Tan Tock Seng Hospital — Singapore, Singapore (enrolling)
• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan (enrolling)
• Kaoshiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan (enrolling)
• Far Eastern Memorial Hospital — New Taipei City, Taiwan (enrolling)
• Taipei Tzuchi Hospital — New Taipei City, Taiwan (enrolling)
• National Taiwan University Hospital — Taipei, Taiwan (enrolling)
• Shin Kong Wu Ho-Su Memorial Hospital — Taipei, Taiwan (enrolling)
• Linkou Chang Gung Memorial Hospital — Taoyuan City, Taiwan (enrolling)
• Phramongkutklao Hospital — Bangkok, Thailand (enrolling)
• Rajavithi Hospital — Bangkok, Thailand (enrolling)
• Ng Teng Fong General Hospital — Singapore, Singapore
• Ramathibodi Hospital — Bangkok, Thailand
• China Medical University Hospital — Taichung, Taiwan

Full record on ClinicalTrials.gov

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