RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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.

Quick Facts

Study Start:2025-05-20
Study Completion:2031-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06271590

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Subject is ≥18 and \<80 years old
  3. 3. Subject is willing to comply with all protocol-required follow-up evaluations and provides written informed consent
  1. 1. Planned (staged) intervention in the target vessel
  2. 2. ST-segment-elevation MI within 48 hours prior to index procedure
  3. 3. Subjects with acute cardiac decompensation or cardiogenic shock
  4. 4. Subject with a life expectancy of less than 24 months
  5. 5. Impaired renal function (glomerular filtration rate \[GFR\] \<30 mL/min)
  6. 6. Documented left ventricular ejection fraction (LVEF) ≤30%
  7. 7. Known allergies to acetylsalicylic acid, clopidogrel, prasugrel, ticagrelor, heparin, contrast medium, sirolimus or similar drugs (i.e., ABT-578 \[Zotarolimus\], biolimus, tacrolimus)
  8. 8. Relative or absolute contraindication to dual antiplatelet therapy (DAPT) for at least 1 month (e.g., planned surgeries that cannot be delayed)
  9. 9. Subject has an indication for chronic oral anticoagulation treatment and a contraindication for concomitant treatment with a P2Y12 inhibitor
  10. 10. If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath
  11. 11. Hemoglobin \<9 g/dL
  12. 12. Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3
  13. 13. White blood cell count \<3,000 cells/mm3
  14. 14. Active infection undergoing treatment
  15. 15. Clinically significant liver disease
  16. 16. Cerebrovascular accident (CVA) within 3 months or has any permanent neurological defect as a result of CVA
  17. 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. 18. Subject is unlikely to comply with the follow up requirements, per investigator's assessment
  19. 19. Subject currently enrolled in other investigational device or drug trial in which primary endpoint has not been reached
  20. 20. Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study

Contacts and Locations

Study Contact

Farhana Siddique
CONTACT
+919725495366
farhana@conceptmedical.com
Dario Gattuso
CONTACT
+393292467132
dario@conceptmedical.com

Study Locations (Sites)

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
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
United States
Minneapolis Heart Institute Foundation (Abbott)
Minneapolis, Minnesota, 55407
United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801
United States
Atlanticare Regional Medical Center
Pomona, New Jersey, 08401
United States
Montefiore Medical Center
Bronx, New York, 10467
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
New York, New York, 10032
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)
Pittsburg, 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

Collaborators and Investigators

Sponsor: Concept Medical Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-20
Study Completion Date2031-11

Study Record Updates

Study Start Date2025-05-20
Study Completion Date2031-11

Terms related to this study

Keywords Provided by Researchers

  • Drug coated balloon
  • Sirolimus coated balloon
  • De Novo
  • Magic Touch
  • SCB
  • Concept Medical
  • Small Vessel
  • MAGICAL SV

Additional Relevant MeSH Terms

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