Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease
Randomized Controlled Trial of First Sirolimus Coated Balloon Versus Standard Balloon Angioplasty in The Treatment of Superficial Femoral Artery and Popliteal Artery Disease
Concept Medical Inc.
279 participants
Sep 8, 2020
INTERVENTIONAL
Conditions
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 of superficial and popliteal arterial disease.
Eligibility
Inclusion Criteria5
- Age ≥ 21 years or minimum age
- Rutherford class 3 to 6 in the target limb
- Single or sequential de novo or re-stenotic lesions (stenosis of > 50% or occlusions) from 2 to 20cm in the femoropopliteal arteries. Lesion is considered as one lesion if there is maximum of 30mm gap between lesions at discretion of investigator. Femoropopliteal arteries are superficial femoral artery, popliteal artery P1 and P2
- 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.
- At least one non-occluded crural vessel (ie. without significant stenosis) with angiographically documented run off to the foot.
Exclusion Criteria15
- 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
- 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)
- Failure to obtain <30% residual stenosis in a pre-existing lesion
- Highly calcific lesions
- Use of DCBs, drug eluting stent, specialty balloons or artherectomy devices during the index procedure. (Non-compliant balloons are not considered specialty balloons)
- Lesions requiring retrograde access (SAFARI)
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Interventions
For participants randomised to MagicTouch PTA sirolimus DCB, following successful plain balloon angioplasty of the arterial lesion, (defined as \<30% residual stenosis after treatment at rated burst pressure of the angioplasty balloon), MagicTouch PTA sirolimus coated balloon will be applied at the lesion after appropriate sizing using the diameter of the plain balloon angioplasty.
For participants randomised to the standard balloon angioplasty group, a placebo standard balloon which is identical to the SCB will also be applied at the lesion after appropriate sizing using the diameter of the plain balloon angioplasty.
Locations(20)
View Full Details on ClinicalTrials.gov
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NCT04511234