Sirolimus Coated Balloon for Peripheral Arterial Disease

(MAGICAL BTK Trial)

Recruiting at 4 trial locations

Overseen By Dario Gattuso

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Concept Medical Inc.

Must be taking: Antiplatelet agents

Must not be taking: Sirolimus

Disqualifiers: Pregnancy, Osteomyelitis, Severe renal disease, others

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 61

Duration: Immediate procedure

368 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 2 6 7 8}

How 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. ^{1 2 3 7 9}

Research Team

Sahil Parikh, MD

Principal Investigator

New York-Presbyterian/Columbia University Irving Pavilion

Eligibility 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.

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

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

Treatment Details

Interventions

• Sirolimus Coated Balloon

Trial Overview 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.

Participant Groups

Group I: MagicTouch PTA sirolimus DCB Active Control 1 Intervention

MagicTouch PTA sirolimus drug coated balloon (DCB) in addition to standard balloon angioplasty

Group II: Placebo balloon angioplasty Placebo Group 1 Intervention

Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA)

Who Is Running the Clinical Trial?

Concept Medical Inc.

Lead Sponsor

Trials

10

Recruited

6,800+

Findings from Research

Sirolimus-coated balloons (SCB) have shown promising results as a treatment for peripheral arterial disease (PAD), demonstrating good short-term effectiveness and safety without major adverse events in clinical use.

Ongoing studies are investigating the efficacy of SCBs compared to traditional treatments like plain balloon angioplasty, as well as their potential use in improving failing arteriovenous fistulas for hemodialysis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of sirolimus coated balloons in the peripheral vasculature - a review of the current literature. Linn, YL., Choke, ETC., Yap, CJQ., et al.[2022]

This phase III randomized controlled trial aims to evaluate the efficacy and safety of sirolimus-coated balloon angioplasty in treating infra-inguinal peripheral arterial disease, focusing on hard clinical outcomes like unplanned amputations and revascularization within one year.

The study will also assess long-term safety by collecting mortality data for up to 5 years, addressing previous safety concerns associated with paclitaxel-coated devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Barco, S., Sebastian, T., Voci, D., et al.[2022]

In a pilot study involving 50 patients with symptomatic peripheral arterial occlusive disease, the MagicTouch sirolimus-coated balloon demonstrated an impressive 80% primary patency rate at 6 months, indicating its effectiveness in preventing restenosis.

The study also reported high rates of limb salvage (92.9%) and freedom from clinically driven target lesion revascularization (89.7%) at 12 months, with no significant safety concerns noted, suggesting that this treatment could be a viable option for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MagicTouch PTA Sirolimus Coated Balloon for Femoropopliteal and Below the Knee Disease: Results From XTOSI Pilot Study Up To 12 Months. Choke, E., Tang, TY., Peh, E., et al.[2022]

In a study involving 476 patients with peripheral artery disease, angioplasty using a paclitaxel-coated balloon resulted in a significantly higher primary patency rate at 12 months (65.2%) compared to standard angioplasty (52.6%), indicating improved long-term vessel openness.

The paclitaxel-coated balloon demonstrated noninferior safety compared to standard angioplasty, with 83.9% of patients free from primary safety events, suggesting it is a safe and effective treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease. Rosenfield, K., Jaff, MR., White, CJ., et al.[2022]

The study evaluated the safety and efficacy of an everolimus-coated balloon (ECB) in a swine coronary artery model, involving 32 swine and a 90-day observation period.

Results indicated that the ECB was safe and effective, with group A (2.5 μg/mm2 drug load) showing the lowest intimal area and group B (7.5 μg/mm2) demonstrating the least stenosis, suggesting that the drug dose may influence the balloon's biocompatibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of an Innovative Everolimus-Coated Balloon in a Swine Coronary Artery Model. Katsouras, CS., Tousis, A., Vasilagkos, G., et al.[2023]

In a randomized trial involving 294 patients, a low-dose drug-coated balloon (DCB) demonstrated superior safety compared to an uncoated balloon, with 94.1% of DCB patients free from major complications at 30 days, compared to 83.3% for the uncoated balloon.

The DCB also showed significantly better effectiveness, achieving 83.9% primary patency at 12 months versus 60.6% for the uncoated balloon, indicating it is a more effective treatment for peripheral artery disease in the femoropopliteal region.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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). Schroeder, H., Werner, M., Meyer, DR., et al.[2018]

In a study of 83,225 patients undergoing femoropopliteal intervention, those treated with drug-coated balloons experienced significantly lower rates of all-cause hospitalization, mortality, and major lower extremity amputation within one year compared to those treated with conventional balloon angioplasty.

Despite the safety benefits, patients using drug-coated balloons were more likely to require repeat femoropopliteal interventions, indicating a need for further research to understand this outcome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use and 1-year outcomes with conventional and drug-coated balloon angioplasty in patients with lower extremity peripheral artery disease. Long, CA., Zepel, L., Greiner, MA., et al.[2022]

Paclitaxel drug-coated balloons and drug-eluting stents, introduced for treating intermittent claudication, showed better limb revascularization compared to non-coated devices, but recent studies raised concerns about a potential increase in late all-cause mortality associated with these treatments.

In response to these safety concerns, a Vascular Leaders Forum was convened with 100 experts from various fields to investigate the findings and discuss the implications for patient care, aiming to balance the risks and benefits of these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel-Coated Balloons and Eluting Stents: Is There a Mortality Risk in Patients With Peripheral Artery Disease? Beckman, JA., White, CJ.[2020]

Endovascular revascularization using paclitaxel-coated balloons is effective for treating peripheral artery disease in the femoropopliteal segment, but there is conflicting evidence regarding its safety in the infra-popliteal segment, with increased risks of amputation and mortality observed after two years.

Pilot studies suggest that sirolimus-coated balloons may be a safer alternative, showing comparable efficacy to paclitaxel-coated balloons without the same cytotoxic risks, with primary patency rates of 79%-82% for femoropopliteal and 59% for infra-popliteal segments at 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Angioplasty with Sirolimus-coated Balloon: the New Standard in the Treatment of PAD?] Teichgräber, UK., Ingwersen, M.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Utility of sirolimus coated balloons in the peripheral vasculature - a review of the current literature. [2022]

2. England pubmed.ncbi.nlm.nih.gov

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]

3. United States pubmed.ncbi.nlm.nih.gov

MagicTouch PTA Sirolimus Coated Balloon for Femoropopliteal and Below the Knee Disease: Results From XTOSI Pilot Study Up To 12 Months. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of an Innovative Everolimus-Coated Balloon in a Swine Coronary Artery Model. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

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]

7. United States pubmed.ncbi.nlm.nih.gov

Use and 1-year outcomes with conventional and drug-coated balloon angioplasty in patients with lower extremity peripheral artery disease. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Paclitaxel-Coated Balloons and Eluting Stents: Is There a Mortality Risk in Patients With Peripheral Artery Disease? [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

[Angioplasty with Sirolimus-coated Balloon: the New Standard in the Treatment of PAD?] [2023]