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.

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Coronary Artery Disease; Native Coronary Artery Stenosis
• Intervention / Treatment: Device: Sirolimus Drug Coated Balloon; Device: Drug eluting stents (DES)

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.

• Study Type: Interventional
• Enrollment (Estimated): 1605
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dario Gattuso; Phone Number: +393292467132; Email: dario@conceptmedical.com
• Study Contact Backup: Name: Farhana Siddique; Phone Number: +919725495366; Email: farhana@conceptmedical.com

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85297
      • Not yet recruiting
      • Dignity Health - Mercy Gilbert Medical Center
      • Contact: Jennifer Zumbuhl; Phone Number: 480-728-9973; Email: Jennine.Zumbuhl@commonspirit.org
  • California
    • Los Angeles, California, United States, 90048
      • Not yet recruiting
      • Cedars-Sinai Medical Center
      • Contact: Mitch Gheorghiu; Phone Number: 310 4236152; Email: mitch.gheorghiu@cshs.org
  • Florida
    • Clearwater, Florida, United States, 33756
      • Recruiting
      • Clearwater Cardiovascular and Interventional Consultants
      • Contact: Jessica Cain; Phone Number: 727-467-9393; Email: cainj@cccheart.com
    • Jacksonville, Florida, United States, 32209
      • Not yet recruiting
      • University of Florida Health Sciences Center-Jacksonville
      • Contact: Andrea Burlton; Phone Number: 904-244-5617; Email: andrea.burton@ufhealth.org
    • Tallahassee, Florida, United States, 32308
      • Not yet recruiting
      • Tallahassee Research Institute
      • Contact: Wendie Najdowski; Phone Number: 850-431-5024; Email: wendie.najdowski@tmh.org
    • Tampa, Florida, United States, 33606
      • Not yet recruiting
      • Tampa General Hospital / University of South Florida
      • Contact: Gabriel Parker; Phone Number: (813) 810-5700; Email: gparker4@usf.edu
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Not yet recruiting
      • Emory University Hospital /Emory School of Medice
      • Contact: Mutsa Seremwe; Phone Number: 404-712-5622; Email: mutsa.seremwe@emory.edu
    • Decatur, Georgia, United States, 30033
      • Not yet recruiting
      • Atlanta VA Medical Center
      • Contact: Susan Muly; Phone Number: 4042638204; Email: Susan.Muly@va.gov
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Not yet recruiting
      • Loyola University Medical Center
      • Contact: Tracy Bielecki Smith; Phone Number: 7083272761; Email: tbielecki@luc.edu
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Not yet recruiting
      • North Mississippi Medical Center
      • Contact: Yvonne Ray; Phone Number: (662) 377-5447; Email: YRay@nmhs.net
  • New Jersey
    • Pomona, New Jersey, United States, 08401
      • Recruiting
      • Atlanticare Regional Medical Center
      • Contact: Jacqueline White; Phone Number: 609-404-7654; Email: JMWhite@atlanticare.org
  • New York
    • Brooklyn, New York, United States, 11215
      • Not yet recruiting
      • University Hospitals, Cleveland Medical Center
      • Contact: Jhané Phanor; Phone Number: 917-679-1951; Email: jhp4004@nyp.org
    • Manhasset, New York, United States, 11030
      • Not yet recruiting
      • North Shore University Hospital - Northwell
      • Contact: Emma Graze; Phone Number: 516-562-4100; Email: clinicalresearch@northwell.edu
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai/ Mount Sinai Hospital
      • Contact: Nimisha Baruah; Phone Number: 212-241-9687; Email: nimisha.baruah@mountsinai.org
    • New York, New York, United States, 10032
      • Not yet recruiting
      • Columbia University/NYP
      • Contact: Treena Williams; Phone Number: 212-342-3485; Email: taw2112@cumc.columbia.edu
    • The Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
      • Contact: Regina Hanstein; Phone Number: 646-648-6125; Email: hanstein@montefiore.org
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Not yet recruiting
      • NC Heart and Vascular Research, LLC
      • Contact: Rebecca Palermo; Phone Number: (919) 745-0750; Email: Rebecca.palermo@unchealth.unc.edu
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Not yet recruiting
      • Cleveland Clinic
      • Contact: Claire Licina; Phone Number: 216-442-5574; Email: licinac@ccf.org
    • Cleveland, Ohio, United States, 44106
      • Not yet recruiting
      • University Hospitals, Cleveland Medical Center
      • Contact: Stacey Mazzurco; Phone Number: 12169785519; Email: Stacey.Mazzurco@uhhospitals.org
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Not yet recruiting
      • University of Oklahoma Health Science Center
      • Contact: Aurora Vera; Phone Number: 405-308-3570; Email: Aurora-Vera@ouhsc.edu
  • Oregon
    • Portland, Oregon, United States, 97225
      • Not yet recruiting
      • Providence St. Vincent Medical Center
      • Contact: Bethany Wilson; Phone Number: 503-2167275; Email: bethany.wilson@providence.org
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15123
      • Not yet recruiting
      • University of Pittsburgh Medical Center (UPMC)
      • Contact: Kristin Shoemaker; Phone Number: 412-692-2769; Email: shoeka@UPMC.EDU
  • Texas
    • Plano, Texas, United States, 75093
      • Recruiting
      • Baylor Scott & White The Heart Hospital - Plano
      • Contact: Walter Cerqueira; Phone Number: 817-922-2586; Email: walter.cerqueira@bswhealh.org
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Not yet recruiting
      • West Virginia University Heart & Vascular Institute
      • Contact: Kimberly Quedado; Phone Number: 304-285-1980; Email: Kimberly.Quedado@wvumedicine.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Clinical Inclusion Criteria:

1. 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)
2. Subject is ≥18 and <80 years old

3. Subject is willing to comply with all protocol-required follow-up evaluations and provides written informed consent

   Angiographic Inclusion Criteria:

4. Target reference vessel diameter (visual estimation) ≤2.75 mm
5. Successful lesion preparation (residual stenosis <30%), without flow-limiting complications (no or slow flow, dissection etc.)
6. Target lesion(s) in a native coronary artery
7. Up to two small vessel target lesions in two different vessels
8. Target lesion length (visual estimation): ≥6.0 and ≤34.0 mm and can be covered by a single 40 mm balloon
9. Target lesion diameter stenosis (visual estimation) >30% and <100% with Thrombolysis in Myocardial Infarction (TIMI) flow grade ≥2

Clinical Exclusion Criteria:

1. Planned (staged) intervention in the target vessel
2. ST-segment-elevation MI within 48 hours prior to index procedure
3. Subjects with acute cardiac decompensation or cardiogenic shock
4. Subject with a life expectancy of less than 24 months
5. Impaired renal function (glomerular filtration rate [GFR] <30 mL/min)
6. Documented left ventricular ejection fraction (LVEF) ≤30%
7. Known allergies to acetylsalicylic acid, clopidogrel, prasugrel, ticagrelor, heparin, contrast medium, sirolimus or similar drugs (i.e., ABT-578 [Zotarolimus], biolimus, tacrolimus)
8. Relative or absolute contraindication to dual antiplatelet therapy (DAPT) for at least 1 month (e.g., planned surgeries that cannot be delayed)
9. Subject has an indication for chronic oral anticoagulation treatment and a contraindication for concomitant treatment with a P2Y12 inhibitor
10. If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath
11. Hemoglobin <9 g/dL
12. Platelet count <100,000 cells/mm3 or >700,000 cells/mm3
13. White blood cell count <3,000 cells/mm3
14. Active infection undergoing treatment
15. Clinically significant liver disease
16. Cerebrovascular accident (CVA) within 3 months or has any permanent neurological defect as a result of CVA
17. Subject is receiving oral or intravenous immunosuppressive therapy (e.g., inhaledsteroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
18. Subject is unlikely to comply with the follow up requirements, per investigator's assessment
19. Subject currently enrolled in other investigational device or drug trial in which primary endpoint has not been reached

20. Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study

    Angiographic Exclusion Criteria:

    All exclusion criteria apply to the target lesion(s) or target vessel(s)

21. Re-stenotic lesion(s), whether due to percutaneous old balloon angioplasty (POBA) or prior stenting
22. True bifurcation lesion (lesion involves both main and side branch>2.5 mm) with planned treatment of both branches per investigator assessment
23. Angiographic evidence of thrombus in the target vessel
24. Myocardial bridging
25. Target lesion is heavily calcified
26. Diffuse distal disease to target lesion with impaired runoff, TIMI flow <2
27. Non-target lesion in the target vessel requiring PCI

Note: Non-target vessel PCI is allowed at the time of index procedure if performed prior to study intervention and if successful and uncomplicated. For target lesions located in branches of the three main vessels (left anterior descending artery [LAD], left circumflex artery [LCx], right coronary artery [RCA]), the term target vessel refers to the branch and not the main vessel.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: Drug coated Balloon
Active Comparator: Drug eluting stents (DES); Everolimus eluting stents (EES) or Zotarolimus eluting stents (ZES)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	defined as residual diameter stenosis <30% (DS), no flow-limiting dissection and with post-procedure The thrombolysis in myocardial infarction (TIMI) 3 flow, without the need for bailout stenting	at baseline, during the procedure
Target lesion failure (TLF)	defined as the composite of cardiovascular mortality, target-vessel myocardial infarction (TVMI) and ischemia driven target lesion revascularization	30 days and at 6, 12, 24, 36, 48, and 60 months
Ischemia driven target vessel revascularization (ID-TVR)	Repeat revascularization of the target lesion due to recurrent ischemia	30 days and at 6, 12, 24, 36, 48, and 60 months
Target vessel revascularization (TVR)	Repeat revascularization of the target vessel	30 days and at 6, 12, 24, 36, 48, and 60 months
Any revascularization	any repeat PCI	30 days and at 6, 12, 24, 36, 48, and 60 months
Target vessel failure (TVF)	defined as the composite of cardiovascular mortality,ischemia driven TVR and TVMI	30 days and at 6, 12, 24, 36, 48, and 60 months
Q-wave myocardial infarction (MI)	Myocardial Infarction demonstrated by new pathological Q waves on ECG	30 days and at 6, 12, 24, 36, 48, and 60 months
Non Q-wave myocardial infarction (MI)	Myocardial Infarction not demonstrated by new pathological Q waves on ECG	30 days and at 6, 12, 24, 36, 48, and 60 months
Any myocardial infarction (MI)		30 days and at 6, 12, 24, 36, 48, and 60 months
Target vessel myocardial infarction (TV MI)		30 days and at 6, 12, 24, 36, 48, and 60 months
Spontaneous myocardial infarction (MI)		30 days and at 6, 12, 24, 36, 48, and 60 months
Procedural myocardial infarction (MI)		Evaluated at 48 hours
Cardiovascular mortality		30 days and at 6, 12, 24, 36, 48, and 60 months
All-cause mortality		30 days and at 6, 12, 24, 36, 48, and 60 months
Cardiovascular mortality or myocardial infarction (MI)		30 days and at 6, 12, 24, 36, 48, and 60 months
All-cause mortality or MI		30 days and at 6, 12, 24, 36, 48, and 60 months
All-cause mortality, myocardial infarction (MI) or target vessel revascularization (TVR)		30 days and at 6, 12, 24, 36, 48, and 60 months
Any probable or definite stent thrombosis		Evaluated at 48 hours
Probable stent thrombosis	Defined as per the Academic Research Consortium (ARC) criteria	30 days and at 6, 12, 24, 36, 48, and 60 months
Definite stent thrombosis	Defined as per the Academic Research Consortium (ARC) criteria	30 days and at 6, 12, 24, 36, 48, and 60 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angina as assessed by SAQ-7 (Seattle Angina Questionnaire)	Angina will be assessed at these specified timepoints and prior to any invasive procedure -Last angina assessment prior to any repeat coronary angiogram will be considered and subsequent assessments will be censored	Quality of Life Endpoint evaluated at 30 days, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: Concept Medical Inc.
• Collaborators: Cardiovascular Research Foundation, New York

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2031

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: SCB; De Novo; Drug coated balloon; Sirolimus coated balloon; Magic Touch; Concept Medical; Small Vessel; MAGICAL SV
• Additional Relevant MeSH Terms: Vascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Cardiovascular Diseases; Coronary Artery Disease; Equipment and Supplies; Prostheses and Implants; Stents; Drug-Eluting Stents
• Other Study ID Numbers: CM-US-R03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No