NCT06271590

MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels

The MAGICAL SV Trial - A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Non Inferiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus-Coated Balloon in the Treatment of Small Vessels in Patients With Coronary Artery Disease.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,605 (estimated)
• Sponsor: Concept Medical Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Subjects with small vessel CAD (Coronary artery disease) presenting with lesions undergoing PCI (Percutaneous coronary intervention) will be randomized into two groups: treatment with the MagicTouch™ sirolimus-coated balloon or DCB (drug-coated balloon) on a 2:1 basis. Approximately 1605 subjects will be enrolled in the randomized study. Treatment of a single lesion in a single major coronary artery or side branch will be enrolled per the inclusion and exclusion criteria. Target lesion must be located in a native coronary artery with a visually estimated diameter of\<2.75 mm to length (including tandem lesions) ≤34.0 mm by visual estimation, and diameter stenosis ≥50% to \<100% in symptomatic patients or ischemia by coronary physiology in patients without symptoms. The primary endpoint is TLF (target lesion failure) at 12 months after intervention. All subjects providing informed consent will have their medical history reviewed and will undergo a physical examination, laboratory screen, and a standardized 12-lead ECG within 7 days of procedure. Women of childbearing potential will have a pregnancy test within one week prior to the procedure. SAQ-7 (Seattle Angina Questionnaire) will be collected at baseline, 30 days, 6 months, and 12 months and prior to any planned intervention.

Conditions

• Coronary Artery Disease
• Native Coronary Artery Stenosis
• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	Sirolimus Drug Coated Balloon	Magic TouchTM (Concept Medical) is a semi-compliant sirolimus drug coated balloon (SCB) for PCI, based on a polymer-free and nanocarrier based drug delivery technology.
DEVICE	Drug eluting stents (DES)	For subjects randomized to the control group (DES), the treating physician will choose an FDA cleared DES (ZES or EES) and follow lesion preparation and stent deployment according to the Instructions per use (IFU) and institutional practices.

Timeline

• Start date: 2025-05-20
• Primary completion: 2028-11-01
• Completion: 2031-11-01
• First posted: 2024-02-22
• Last updated: 2025-09-11

Locations

24 sites across 1 country: United States

Regulatory

• FDA-regulated device study