Sirolimus Coated Balloon for Peripheral Arterial Disease
(MAGICAL BTK Trial)
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Concept Medical Inc.
Must be taking: Antiplatelet agents
Must not be taking: Sirolimus
Disqualifiers: Pregnancy, Osteomyelitis, Severe renal disease, others
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This is a Pivotal, Prospective, randomised, two arm, placebo controlled, single-blind, multicentre trial that will be conducted at approximately 70 sites; approx. 40 sites with at least 50% of subjects will be recruited from USA and approx. 30 sites OUS - Singapore, Australia and Japan. 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).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it mentions that you cannot participate if you have a bleeding disorder that prevents the use of required antiplatelet agents, which suggests that some medication adjustments might be necessary. Please consult with the trial coordinators for specific guidance.
What data supports the effectiveness of the sirolimus-coated balloon treatment for peripheral arterial disease?
Sirolimus-coated balloons have shown promise in treating peripheral arterial disease by preventing the narrowing of blood vessels after treatment, similar to how they are used in coronary artery disease. Studies have shown good short-term results, with no major side effects, and they are being compared to other treatments like plain balloon angioplasty to further establish their effectiveness.
12345Is the Sirolimus Coated Balloon safe for use in humans?
Sirolimus-coated balloons have shown clinical safety in treating coronary artery disease and have not exhibited major adverse events in short-term use for peripheral arterial disease. They have been tested pre-clinically and are considered a promising alternative to other drug-coated balloons.
12678How does the sirolimus-coated balloon treatment differ from other treatments for peripheral arterial disease?
The sirolimus-coated balloon is unique because it uses sirolimus, which is cytostatic (slows cell growth) rather than cytotoxic (kills cells), offering a potentially safer alternative to paclitaxel-coated balloons that have been linked to higher risks of amputation and mortality. This treatment also optimizes drug delivery through phospholipid nanocarriers, improving the drug's adhesion and bioavailability.
12379Eligibility Criteria
This trial is for adults over 21 with below-the-knee arterial blockages, classified as Rutherford class 4-6. Participants should have one or more lesions in specific leg arteries and good blood flow after treatment of any inflow issues. Those with severe artery narrowing (>50% stenosis) not treated before the study can't join.Inclusion Criteria
Rutherford class 4 with documented WIFI score, not exceeding more than 30% of target patient population
My leg's main artery is mostly unblocked and flows well into one of the smaller arteries.
I am over 21 years old or meet my state's legal adult age.
+2 more
Exclusion Criteria
Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet
Subject is lactating, pregnant or planning to become pregnant during the course of the study
Failure to obtain <30% residual stenosis prior to randomization
+14 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either the MagicTouch PTA sirolimus drug coated balloon (DCB) or placebo balloon angioplasty in addition to standard balloon angioplasty
Immediate procedure
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of primary patency and adverse events
60 months
Multiple visits over 60 months
Long-term follow-up
Participants are monitored for long-term outcomes such as amputation-free survival and quality of life
60 months
Participant Groups
The trial tests a sirolimus drug coated balloon (MagicTouch PTA) against a placebo balloon during angioplasty to treat below-the-knee arterial disease. Patients are randomly assigned to either group, and the effectiveness and safety of both treatments are compared.
2Treatment groups
Active Control
Placebo Group
Group I: MagicTouch PTA sirolimus DCBActive Control1 Intervention
MagicTouch PTA sirolimus drug coated balloon (DCB) in addition to standard balloon angioplasty
Group II: Placebo balloon angioplastyPlacebo Group1 Intervention
Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Columbia University Irving Medical CenterNew York, NY
Vascular Institute of the MidwestDavenport, IA
Northwell Health Long Island Jewish Medical CenterLake Success, NY
The Mount Sinai HospitalNew York, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Concept Medical Inc.Lead Sponsor
References
Utility of sirolimus coated balloons in the peripheral vasculature - a review of the current literature. [2022]Sirolimus-coated balloons (SCB) have demonstrated much promise as an alternative drug eluting device to the existing paclitaxel coated balloon platforms for the treatment of peripheral arterial disease (PAD). They have been well tested pre-clinically and have demonstrated anti-restenotic effects as well as clinical safety in its use for treatment of coronary artery disease. The existing approved SCBs have thus far demonstrated good short-term patency (12-months) and did not exhibit any major adverse events or device related shortcomings in its use for treatment of PAD. There are several studies ongoing which aim to further investigate the efficacy of existing SCBs and establish a direct comparison of its outcomes compared with plain balloon angioplasty. Also, SCB utility to salvage failing arteriovenous fistulas for haemodialysis patients has also been explored. We review the current progress made in the establishment of SCB in the treatment of PAD as well as highlight ongoing studies investigating the role of SCB in various settings.
Major adverse limb events in patients with femoro-popliteal and below-the-knee peripheral arterial disease treated with either sirolimus-coated balloon or standard uncoated balloon angioplasty: a structured protocol summary of the "SirPAD" randomized controlled trial. [2022]Peripheral arterial disease is a progressive atherosclerotic disease with symptoms ranging from an intermittent claudication to acute critical limb ischemia and amputations. Drug-coated balloons and stents were developed to prevent neo-intimal proliferation and restenosis after percutaneous transluminal angioplasty. Randomized controlled trials showed that drug-coated, notably paclitaxel-coated, devices reduce restenosis, late lumen loss, and the need for target lesion re-vascularization compared with uncoated ones. However, the size of these trials was too small to prove superiority for "hard" clinical outcomes. Moreover, available studies were characterized by too restrictive eligibility criteria. Finally, it remains unclear whether paclitaxel-coated balloons may impair long-term survival. Alternative drug-coated balloons, the so-called limus-based analogs, have been approved for clinical use in patients with peripheral arterial disease. By encapsulating sirolimus in phospholipid drug nanocarriers, they optimize adhesion properties of sirolimus and provide better bioavailability.
MagicTouch PTA Sirolimus Coated Balloon for Femoropopliteal and Below the Knee Disease: Results From XTOSI Pilot Study Up To 12 Months. [2022]Sirolimus coated balloon (SCB) is a promising treatment option to prevent restenosis for peripheral arterial occlusive disease (PAOD). This is a pilot first-in-human study of MagicTouch percutaneous transluminal angioplasty (PTA) SCB for treatment of PAOD for both femoropopliteal and below the knee arteries (BTK).
Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease. [2022]The treatment of peripheral artery disease with percutaneous transluminal angioplasty is limited by the occurrence of vessel recoil and restenosis. Drug-coated angioplasty balloons deliver antiproliferative agents directly to the artery, potentially improving vessel patency by reducing restenosis.
Safety and Efficacy of an Innovative Everolimus-Coated Balloon in a Swine Coronary Artery Model. [2023]Drug-coated balloons have been used as a non-stenting treatment in coronary and peripheral artery disease. Until recently, only sirolimus- and paclitaxel-coated balloons have been investigated in clinical trials. We evaluated the safety and efficacy of an innovative everolimus-coated balloon (ECB) in a swine coronary artery model.
Low-Dose Paclitaxel-Coated Versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease: One-Year Results of the ILLUMENATE European Randomized Clinical Trial (Randomized Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon). [2018]Label="BACKGROUND" NlmCategory="BACKGROUND">Numerous studies have reported favorable outcomes using drug-coated balloons (DCBs) for treatment of symptomatic peripheral artery disease of the superficial femoral and popliteal arteries. However, the treatment effect compared with an uncoated balloon has differed greatly among the randomized trials, with better outcomes observed with higher-dose DCBs. This European trial was designed to assess the safety and effectiveness of a next-generation low-dose (2-µg/mm2 surface dose of paclitaxel) DCB.
Use and 1-year outcomes with conventional and drug-coated balloon angioplasty in patients with lower extremity peripheral artery disease. [2022]With the growing use of drug-coated balloons for the treatment of peripheral artery disease, information regarding the safety and effectiveness of drug-coated balloons in current practice is needed. We examined patient, physician, and procedural characteristics as well as cardiovascular and limb events in patients who underwent peripheral vascular intervention with drug-coated balloons.
Paclitaxel-Coated Balloons and Eluting Stents: Is There a Mortality Risk in Patients With Peripheral Artery Disease? [2020]Paclitaxel drug-coated balloons and drug-eluting stents became commercially available for the treatment of intermittent claudication in 2015 and 2012, respectively. Both devices demonstrated superiority in limb revascularization compared with non-paclitaxel-coated devices and were rapidly accepted into clinical practice. In a recent systematic review and study-level meta-analysis, Katsanos et al reported a late all-cause mortality signal for patients in the drug-coated balloon and drug-eluting stent arms of randomized clinical trials for both devices. As a result of this safety signal, Vascular InterVentional Advances Physicians (VIVA), a not-for-profit 501c(3) organization, convened the Vascular Leaders Forum on March 1 and 2, 2019, in Washington, DC, to initiate an open and collaborative process of investigation into this finding. The Vascular Leaders Forum brought together 100 stakeholders, including an international group of representatives of cardiovascular medicine, interventional radiology, vascular medicine, and vascular surgery; oncologists; basic scientists; the Food and Drug Administration; the Centers for Medicare and Medicaid Services; and commercial manufacturers of these products. The Vascular Leaders Forum reviewed the natural history of peripheral arterial disease, the use of paclitaxel in peripheral arterial disease and other conditions, the harm signal noted by Katsanos et al, the impact of the methods chosen by Katsanos et al, possible mechanisms of harm, the role of the Food and Drug Administration in a setting like this one, and guidance for clinicians taking care of patients with symptomatic peripheral arterial disease. This document integrates the most current data to help establish an appropriate path forward to understand the risks and benefits associated with these technologies while ensuring the best treatment paradigm for patients.
[Angioplasty with Sirolimus-coated Balloon: the New Standard in the Treatment of PAD?] [2023]Endovascular revascularisation with paclitaxel-coated balloons for the treatment of peripheral artery disease has been shown to be an effective therapeutic option in the femoropopliteal segment. The antiproliferative effect of paclitaxel prevents restenosis. In contrast, in the infra-popliteal segment, the evidence is currently conflicting. However, there is evidence of an increased risk of amputation and mortality from the second year after angioplasty with paclitaxel-coated balloons. This may be due to a dose-dependent cytotoxic effect of paclitaxel. Sirolimus-coated balloons might therefore be an alternative because sirolimus is cytostatic rather than cytotoxic and thus has a wide therapeutic window.Three single-arm pilot studies (50, 25, and 50 patients, respectively) show that angioplasty with sirolimus-coated balloons leads to comparable results to those reported from paclitaxel-coated balloons (late lumen loss at 6 months: 0.29 mm; primary patency at 12 months: femoropopliteal 79%-82%, infra-popliteal 59%; freedom from target lesion revascularization at 12 months: femoropopliteal 83%-94%, infra-popliteal 86%). Randomised controlled trials comparing standard balloon angioplasty and paclitaxel-coated balloons for the treatment of intermittent claudication or chronic limb-threatening ischaemia are active and are expected to provide efficacy and safety results from mid 2024.This review presents the results of pilot studies on angioplasty with sirolimus-coated balloons for the treatment of peripheral artery disease and reviews currently ongoing randomised controlled trials.