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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.
Status: Recruiting
Location: See all (24) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Dignity Health - Mercy Gilbert Medical Center
NOT_YET_RECRUITING
Gilbert
California
Cedars-Sinai Medical Center
NOT_YET_RECRUITING
Los Angeles
Florida
Clearwater Cardiovascular and Interventional Consultants
RECRUITING
Clearwater
University of Florida Health Sciences Center-Jacksonville
NOT_YET_RECRUITING
Jacksonville
Tallahassee Research Institute
NOT_YET_RECRUITING
Tallahassee
Tampa General Hospital / University of South Florida
NOT_YET_RECRUITING
Tampa
Georgia
Emory University Hospital /Emory School of Medice
NOT_YET_RECRUITING
Atlanta
Atlanta VA Medical Center
NOT_YET_RECRUITING
Decatur
Illinois
Loyola University Medical Center
NOT_YET_RECRUITING
Maywood
Mississippi
North Mississippi Medical Center
NOT_YET_RECRUITING
Tupelo
North Carolina
NC Heart and Vascular Research, LLC
NOT_YET_RECRUITING
Raleigh
New Jersey
Atlanticare Regional Medical Center
RECRUITING
Pomona
New York
University Hospitals, Cleveland Medical Center
NOT_YET_RECRUITING
Brooklyn
North Shore University Hospital - Northwell
NOT_YET_RECRUITING
Manhasset
Columbia University/NYP
NOT_YET_RECRUITING
New York
Icahn School of Medicine at Mount Sinai/ Mount Sinai Hospital
RECRUITING
New York
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
Cleveland Clinic
NOT_YET_RECRUITING
Cleveland
University Hospitals, Cleveland Medical Center
NOT_YET_RECRUITING
Cleveland
Oklahoma
University of Oklahoma Health Science Center
NOT_YET_RECRUITING
Oklahoma City
Oregon
Providence St. Vincent Medical Center
NOT_YET_RECRUITING
Portland
Pennsylvania
University of Pittsburgh Medical center (UPMC)
NOT_YET_RECRUITING
Pittsburgh
Texas
Baylor Scott & White The Heart Hospital - Plano
RECRUITING
Plano
West Virginia
West Virginia University Heart & Vascular Institute
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)