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

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.

Conditions

Coronary Artery Disease, Native Coronary Artery Stenosis, Cardiovascular Diseases

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Study Overview

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Study Details

Study overview

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.

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.

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

Condition
Coronary Artery Disease
Intervention / Treatment

-

Contacts and Locations

Gilbert

Dignity Health - Mercy Gilbert Medical Center, Gilbert, Arizona, United States, 85297

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Clearwater

Clearwater Cardiovascular and Interventional Consultants, Clearwater, Florida, United States, 33756

Jacksonville

University of Florida Health Sciences Center-Jacksonville, Jacksonville, Florida, United States, 32209

Tallahassee

Tallahassee Research Institute, Tallahassee, Florida, United States, 32308

Tampa

Tampa General Hospital / University of South Florida, Tampa, Florida, United States, 33606

Atlanta

Emory University Hospital /Emory School of Medice, Atlanta, Georgia, United States, 30322

Decatur

Atlanta VA Medical Center, Decatur, Georgia, United States, 30033

Maywood

Loyola University Medical Center, Maywood, Illinois, United States, 60153

Worcester

University of Massachusetts Chan Medical School, Worcester, Massachusetts, United States, 01655

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Concept Medical Inc.,

Study Record Dates

2031-11