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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Sirolimus Drug Coated Balloon — DEVICE
  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.
• Drug eluting stents (DES) — DEVICE
  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.

Study Details

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.

Key Dates

Start date

May 20, 2025

Status verified

Sep 2025

Primary completion

Nov 30, 2028

Completion

Nov 30, 2031

Study Design

Enrollment

1,605 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: MagicTouch Sirolimus-Coated Balloon (SCB)
  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.
• Active Comparator: Drug eluting stents (DES)
  Everolimus eluting stents (EES) or Zotarolimus eluting stents (ZES)

Primary Outcome Measure

Target lesion failure (TLF) [ Time Frame: within 12 months ]

Central Contacts

• Farhana Siddique
  +919725495366
  [email protected]
• Dario Gattuso
  +393292467132
  [email protected]

Locations (24)

Find similar trials in Gilbert, AZ

Related Studies

• Evaluating Cardiovascular Phenotypes Using Induced Pluripotent Stem Cells
  Enrolling By Invitation · Scripps Translational Science Institute · La Jolla, California
• Product Surveillance Registry
  Recruiting · Medtronic · Birmingham, Alabama
• Efficacy and Saftey Study of 99mTc-ECDG in the Evaluation of Coronary Artery Disease (CAD)
  PHASE2 · Not Yet Recruiting · Cell>Point LLC · Oklahoma City, Oklahoma
• Factors Affect Outcomes in Cardiovascular Surgery
  Recruiting · University of California, Davis · Sacramento, California