MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels
MAGICAL SV
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.
1 other identifier
interventional
1,605
1 country
24
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started May 2025
Longer than P75 for not_applicable coronary-artery-disease
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2024
CompletedFirst Posted
Study publicly available on registry
February 22, 2024
CompletedStudy Start
First participant enrolled
May 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2031
September 11, 2025
September 1, 2025
3.5 years
February 13, 2024
September 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Target lesion failure (TLF)
the composite of cardiovascular mortality, target-vessel myocardial infarction (TV-MI) and ischemia driven target lesion revascularization
within 12 months
Secondary Outcomes (20)
Procedural success
at baseline, during the procedure
Target lesion failure (TLF)
30 days and at 6, 12, 24, 36, 48, and 60 months
Ischemia driven target vessel revascularization (ID-TVR)
30 days and at 6, 12, 24, 36, 48, and 60 months
Target vessel revascularization (TVR)
30 days and at 6, 12, 24, 36, 48, and 60 months
Any revascularization
30 days and at 6, 12, 24, 36, 48, and 60 months
- +15 more secondary outcomes
Other Outcomes (1)
Angina as assessed by SAQ-7 (Seattle Angina Questionnaire)
Quality of Life Endpoint evaluated at 30 days, 6 months, and 12 months
Study Arms (2)
MagicTouch Sirolimus-Coated Balloon (SCB)
EXPERIMENTALMagic 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.
Drug eluting stents (DES)
ACTIVE COMPARATOREverolimus eluting stents (EES) or Zotarolimus eluting stents (ZES)
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Adult patient with an indication for PCI due to stable angina, NSTEACS, post-infarction angina or silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, FFR ≤0.80, or non-hyperemic pressure ratio \[NHPR\] ≤0.89 must be present)
- Subject is ≥18 and \<80 years old
- Subject is willing to comply with all protocol-required follow-up evaluations and provides written informed consent
- Target reference vessel diameter (visual estimation) ≤2.75 mm
- Successful lesion preparation (residual stenosis \<30%), without flow-limiting complications (no or slow flow, dissection etc.)
- Target lesion(s) in a native coronary artery
- Up to two small vessel target lesions in two different vessels
- Target lesion length (visual estimation): ≥6.0 and ≤34.0 mm and can be covered by a single 40 mm balloon
- Target lesion diameter stenosis (visual estimation) \>30% and \<100% with Thrombolysis in Myocardial Infarction (TIMI) flow grade ≥2
You may not qualify if:
- Planned (staged) intervention in the target vessel
- ST-segment-elevation MI within 48 hours prior to index procedure
- Subjects with acute cardiac decompensation or cardiogenic shock
- Subject with a life expectancy of less than 24 months
- Impaired renal function (glomerular filtration rate \[GFR\] \<30 mL/min)
- Documented left ventricular ejection fraction (LVEF) ≤30%
- Known allergies to acetylsalicylic acid, clopidogrel, prasugrel, ticagrelor, heparin, contrast medium, sirolimus or similar drugs (i.e., ABT-578 \[Zotarolimus\], biolimus, tacrolimus)
- Relative or absolute contraindication to dual antiplatelet therapy (DAPT) for at least 1 month (e.g., planned surgeries that cannot be delayed)
- Subject has an indication for chronic oral anticoagulation treatment and a contraindication for concomitant treatment with a P2Y12 inhibitor
- If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath
- Hemoglobin \<9 g/dL
- Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3
- White blood cell count \<3,000 cells/mm3
- Active infection undergoing treatment
- Clinically significant liver disease
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Concept Medical Inc.lead
- Cardiovascular Research Foundation, New Yorkcollaborator
Study Sites (24)
Dignity Health - Mercy Gilbert Medical Center
Gilbert, Arizona, 85297, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Clearwater Cardiovascular and Interventional Consultants
Clearwater, Florida, 33756, United States
University of Florida Health Sciences Center-Jacksonville
Jacksonville, Florida, 32209, United States
Tallahassee Research Institute
Tallahassee, Florida, 32308, United States
Tampa General Hospital / University of South Florida
Tampa, Florida, 33606, United States
Emory University Hospital /Emory School of Medice
Atlanta, Georgia, 30322, United States
Atlanta VA Medical Center
Decatur, Georgia, 30033, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801, United States
Atlanticare Regional Medical Center
Pomona, New Jersey, 08401, United States
University Hospitals, Cleveland Medical Center
Brooklyn, New York, 11215, United States
North Shore University Hospital - Northwell
Manhasset, New York, 11030, United States
Icahn School of Medicine at Mount Sinai/ Mount Sinai Hospital
New York, New York, 10029, United States
Columbia University/NYP
New York, New York, 10032, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
NC Heart and Vascular Research, LLC
Raleigh, North Carolina, 27607, United States
University Hospitals, Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
University of Pittsburgh Medical center (UPMC)
Pittsburgh, Pennsylvania, 15123, United States
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, 75093, United States
West Virginia University Heart & Vascular Institute
Morgantown, West Virginia, 26506, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2024
First Posted
February 22, 2024
Study Start
May 20, 2025
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
November 1, 2031
Last Updated
September 11, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share