Actively Recruiting
MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels
Led by Concept Medical Inc. · Updated on 2025-09-11
1605
Participants Needed
24
Research Sites
336 weeks
Total Duration
On this page
Sponsors
C
Concept Medical Inc.
Lead Sponsor
C
Cardiovascular Research Foundation, New York
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to less than 80 years
- Indication for PCI due to stable angina, NSTEACS, post-infarction angina, or silent ischemia with appropriate diagnostic confirmation
- Willingness to comply with all study follow-up visits and provide informed consent
- Target vessel diameter of 2.75 mm or less
- Successful lesion preparation with residual stenosis less than 30% and no flow-limiting complications
- Target lesion located in a native coronary artery
- Up to two small vessel target lesions in two different vessels
- Target lesion length between 6.0 and 34.0 mm, suitable for coverage by a single 40 mm balloon
- Target lesion diameter stenosis greater than 30% and less than 100% with TIMI flow grade 2 or higher
You will not qualify if you...
- Planned staged intervention in the target vessel
- ST-segment-elevation myocardial infarction within 48 hours before procedure
- Acute cardiac decompensation or cardiogenic shock
- Life expectancy less than 24 months
- Impaired renal function with GFR less than 30 mL/min
- Left ventricular ejection fraction of 30% or less
- Known allergies to aspirin, clopidogrel, prasugrel, ticagrelor, heparin, contrast media, sirolimus, or similar drugs
- Contraindications to dual antiplatelet therapy for at least 1 month
- Indication for chronic oral anticoagulation with contraindication to P2Y12 inhibitors
- Significant peripheral arterial disease preventing safe femoral access
- Hemoglobin less than 9 g/dL
- Platelet count less than 100,000 or greater than 700,000 cells/mm3
- White blood cell count less than 3,000 cells/mm3
- Active infection under treatment
- Clinically significant liver disease
- Recent cerebrovascular accident within 3 months or permanent neurological deficits from stroke
- Use of oral or intravenous immunosuppressive therapy or known life-limiting immunosuppressive/autoimmune disease
- Unlikely to comply with follow-up requirements
- Current enrollment in other investigational device or drug trials with unresolved primary endpoints
- Pregnancy, breastfeeding, or intention to become pregnant during the study
- Re-stenotic lesions or prior stenting at target lesion
- True bifurcation lesions involving both main and side branches greater than 2.5 mm requiring treatment
- Angiographic evidence of thrombus in target vessel
- Myocardial bridging
- Heavily calcified target lesions
- Diffuse distal disease with impaired runoff and TIMI flow less than 2
- Non-target lesion in target vessel requiring PCI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Dignity Health - Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297
Not Yet Recruiting
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Not Yet Recruiting
3
Clearwater Cardiovascular and Interventional Consultants
Clearwater, Florida, United States, 33756
Actively Recruiting
4
University of Florida Health Sciences Center-Jacksonville
Jacksonville, Florida, United States, 32209
Not Yet Recruiting
5
Tallahassee Research Institute
Tallahassee, Florida, United States, 32308
Not Yet Recruiting
6
Tampa General Hospital / University of South Florida
Tampa, Florida, United States, 33606
Not Yet Recruiting
7
Emory University Hospital /Emory School of Medice
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
8
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
Not Yet Recruiting
9
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Not Yet Recruiting
10
North Mississippi Medical Center
Tupelo, Mississippi, United States, 38801
Not Yet Recruiting
11
Atlanticare Regional Medical Center
Pomona, New Jersey, United States, 08401
Actively Recruiting
12
University Hospitals, Cleveland Medical Center
Brooklyn, New York, United States, 11215
Not Yet Recruiting
13
North Shore University Hospital - Northwell
Manhasset, New York, United States, 11030
Not Yet Recruiting
14
Icahn School of Medicine at Mount Sinai/ Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
15
Columbia University/NYP
New York, New York, United States, 10032
Not Yet Recruiting
16
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
17
NC Heart and Vascular Research, LLC
Raleigh, North Carolina, United States, 27607
Not Yet Recruiting
18
University Hospitals, Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
19
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
20
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73104
Not Yet Recruiting
21
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Not Yet Recruiting
22
University of Pittsburgh Medical center (UPMC)
Pittsburgh, Pennsylvania, United States, 15123
Not Yet Recruiting
23
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, United States, 75093
Actively Recruiting
24
West Virginia University Heart & Vascular Institute
Morgantown, West Virginia, United States, 26506
Not Yet Recruiting
Research Team
F
Farhana Siddique
CONTACT
D
Dario Gattuso
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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