Sirolimus-Coated Balloon for Coronary Artery Disease

(MAGICAL SV Trial)

Recruiting at 25 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

Trial Summary

What is the purpose of this trial?

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 vessels in patients with coronary artery disease. The objective is to establish the safety and efficacy of the Magic TouchTM Drug coated balloon in treatment of small vessels (≤2.75 mm). A total of 1605 subjects will be enrolled in a maximum of 50 study sites located in North America. Additional sites located in Europe and South America may also participate in the study, with non-US sites contributing a maximum of \~50% of enrollees.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+