MAGICAL BTK: Randomized Controlled Trial of MAGIcTouch - Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease
Concept Medical Inc.
Summary
This is a Pivotal, Prospective, randomized, two arm, placebo controlled, single-blind, multicenter trial that will be conducted at approximately 80 sites; approx. 50 sites with at least 50% of subjects will be recruited from USA and approx. 30 sites OUS - Europe, Australia and Asia. Each site will be capped at 30 maximum subjects recruited. The main goal of this clinical trial is to determine the effectiveness and safety of the sirolimus drug coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) for the treatment of below the knee arterial disease. Eligible subjects will be randomised in a 1:1 allocation ratio and stratified by recruiting countries. Each subject will be randomized to receive either: 1. MagicTouch PTA sirolimus coated balloon catheter (DCB) in addition to standard balloon angioplasty or 2. Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA).
Description
The burden of limb loss because of peripheral arterial disease (PAD) is high and this problem is set to worsen globally. Treatment of PAD primarily involves revascularisation of the limb. Angioplasty as a first line strategy of revascularization over surgical procedures has been adopted by many vascular centres. In recent years, studies have shown that local drug delivery using drug coated balloons (DCB) during angioplasty for PAD can successfully deliver effective local tissue concentrations of antiproliferative drugs to the lesions in the artery involved in the PAD. This offers the potential…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 21 years or minimum age (is allowed the inclusion of subjects \> 21 years OR adulthood minimum age (depending on the US state regulations) 2. Rutherford class 4 with documented WIFI score, not exceeding more than 30% of target patient population. 3. Rutherford class 5 to 6 in the target limb with documented WIFI score. Intraoperative Inclusion Criteria: 4. 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…
Interventions
- DeviceMagicTouch PTA Sirolimus drug coated balloon
All patients must first be treated with pre dilatation with a standard balloon angioplasty using any standard balloon catheters at the discretion of the operator. Magic Touch PTA Sirolimus coated balloon catheter is an adjunct treatment that should be used in combination with standard balloon angioplasty. Following successful crossing of wire across the lesion and plain balloon angioplasty of arterial lesion with successful lesion preparation with residual lesion \<30%, subjects will be randomized to receive study device balloon. If patients are assigned to MagicTouch PTA Sirolimus DCB, the Angioplasty of lower limb will be performed with this device in addition to standard balloon angioplasty.
- DevicePlacebo balloon angioplasty
For participants randomized to a Placebo balloon angioplasty group, a Placebo balloon angioplasty in addition to standard balloon angioplasty will be performed.
Locations (29)
- Honor Health Research & Innovation InstituteScottsdale, Arizona
- Cedars-Sinai Medical CenterLos Angeles, California
- University of California Los AngelesLos Angeles, California
- Clearwater Cardiovascular ConsultantsClearwater, Florida
- Baptist Hospital of MiamiMiami, Florida
- University of South FloridaTampa, Florida