Sirolimus-Coated Balloon for Coronary Artery Disease

(MAGICAL SV Trial)

Recruiting at 28 trial locations

Overseen By Farhana Siddique

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Concept Medical Inc.

Must be taking: Dual antiplatelet therapy

Must not be taking: Oral anticoagulants, Immunosuppressives

Disqualifiers: Renal impairment, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 5

Duration: During procedure

1605 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with coronary artery disease, focusing on small vessels in the heart. The study aims to evaluate the safety and effectiveness of the MagicTouch™ Sirolimus-Coated Balloon, a medical device, compared to other treatments like drug-eluting stents. Participants should have stable chest pain (angina) or a similar heart condition and a confirmed small blockage in their coronary arteries. This trial may suit those with stable chest pain or a diagnosis of small vessel coronary artery disease. As an unphased trial, it offers a unique opportunity to contribute to the understanding of new treatment options for coronary artery disease.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on oral or intravenous immunosuppressive therapy, you may be excluded from participating.

What prior data suggests that the MagicTouch™ Sirolimus-Coated Balloon is safe for treating coronary artery disease?

Research has shown that the MagicTouch Sirolimus-Coated Balloon is generally safe for people. Studies have found it effective for treating coronary artery disease, especially in small blood vessels. The balloon releases sirolimus, a substance that helps prevent arteries from narrowing again.

In past studies, patients treated with this balloon experienced good results with few serious side effects, suggesting that the treatment is well-tolerated. Most side effects were mild, and no major safety issues were reported.

The MagicTouch balloon has undergone several trials, demonstrating its safety and effectiveness over time. It has been used in people and is generally found to be safe, with most participants not experiencing major problems. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care, which typically involves drug-eluting stents (DES) like Everolimus or Zotarolimus-eluting stents, the MagicTouch™ Sirolimus-Coated Balloon (SCB) offers a unique approach. This treatment uses a Sirolimus-coated balloon to deliver the drug directly to the coronary arteries, addressing atherosclerosis without leaving a permanent metallic stent behind. Researchers are excited because this method minimizes long-term complications associated with metal stents, such as inflammation and restenosis, and provides a more flexible treatment option for patients.

What evidence suggests that this trial's treatments could be effective for coronary artery disease?

Research has shown that the MagicTouch™ Sirolimus-Coated Balloon (SCB), one of the treatments in this trial, effectively treats small blood vessels in heart disease. This balloon uses Nanolutè technology to release sirolimus, a medication that helps keep arteries open, for 8 to 12 weeks. Studies have found that sirolimus-coated balloons achieve similar long-term results to other treatments, such as reducing the need for additional procedures to reopen arteries. They are also as safe as other drug-coated balloons. This trial will compare the MagicTouch™ SCB to drug-eluting stents (DES), another treatment option in the study. The MagicTouch™ SCB could be a promising choice for patients with small vessel heart disease. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with small vessel coronary artery disease (vessel diameter ≤2.75 mm) who need a procedure to open their arteries. They should have stable angina, certain types of heart attack symptoms, or silent ischemia and be able to follow the study plan. People with more than two lesions in different vessels or complications during lesion preparation can't join.

Inclusion Criteria

My targeted blood vessel is smaller than 2.75 mm in diameter.

My heart's blood flow is reduced but not completely blocked.

I agree to follow the study rules and have signed the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants undergo PCI with either the MagicTouch™ sirolimus-coated balloon or a drug-coated balloon

During procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 30 days, 6 months, and 12 months

12 months

3 visits (in-person)

Long-term follow-up

Participants are monitored for long-term outcomes such as stent thrombosis and target vessel failure

60 months

Periodic assessments

What Are the Treatments Tested in This Trial?

Interventions

• MagicTouch™Sirolimus-Coated Balloon

Trial Overview The trial is testing MagicTouchTM Sirolimus Drug Coated Balloon against standard drug-eluting stents for treating narrowings in small heart arteries. It's a large study involving over 1600 patients across North America and possibly Europe and South America.

How Is the Trial Designed?

Group I: MagicTouch Sirolimus-Coated Balloon (SCB) Experimental Treatment 1 Intervention

Magic TouchTM is a Sirolimus Coated Balloon catheter intended to be used in coronary applications, treats the atherosclerosis of the coronary arteries by eluting the immunosuppressant agent Sirolimus without leaving behind a metallic scaffold.

Group II: Drug eluting stents (DES) Active Control 1 Intervention

Everolimus eluting stents (EES) or Zotarolimus eluting stents (ZES)

Who Is Running the Clinical Trial?

Concept Medical Inc.

Lead Sponsor

Trials

10

Recruited

6,800+

Cardiovascular Research Foundation, New York

Collaborator

Trials

28

Recruited

27,800+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06271590

NCT06271590 | MagicTouch™Sirolimus-Coated Balloon ... This is a multicenter, randomized, single-blind pivotal study to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11485756/

Magic Touch sirolimus-coated balloon: animal and clinical ... Among modern drug-coated balloons, Magic Touch features Nanolutè technology, which allows effective and rapid sirolimus release and retention for 8–12 weeks.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1936879823013213

A Prospective Randomized Trial Comparing Sirolimus ... This study sought to compare quantitative coronary angiographic outcomes at 6 months after treatment of de novo SVD with a PCB or SCB.

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.124.014064

Long-Term Outcomes Following Sirolimus-Coated Balloon ... Sirolimus-coated balloons were associated with comparable risk of target lesion revascularization, target vessel revascularization, myocardial ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39105679/

Magic Touch sirolimus-coated balloon: animal and clinical ... The SCB represents a promising novelty within the drug-coated balloon arena due to its mid-term efficacy and safety in the treatment of coronary ...

6. conceptmedical.com conceptmedical.com/magictouch-scb/

MagicTouch SCB - Sirolimus Coated Balloon The world's first sirolimus coated balloon proven in multiple trials for safety, efficacy, and long-term vessel patency.