Actively Recruiting
MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions
Led by Concept Medical Inc. · Updated on 2025-02-25
492
Participants Needed
28
Research Sites
219 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
A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus- Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis. Subjects with prior DES implantation presenting with ISR lesions undergoing PCI will be randomized into two groups: treatment with the MagicTouch™ sirolimus-coated balloon or POBA on a 2:1 basis. Approximately 492 subjects will be enrolled in the randomized study in a maximum of 50 study sites located in the United States. The goal is to establish the safety and efficacy of the MagicTouch™ sirolimus- coated balloon in treatment of coronary in-stent restenosis (ISR).
CONDITIONS
Official Title
MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is at least 18 years old
- Subject or legal guardian understands the trial and provides written informed consent
- Patient has indication for PCI due to suspected in-stent restenosis
- Non-target lesion PCI allowed if treated with approved devices before randomization
- In-stent restenosis after drug-eluting stent implantation in target lesion
- Target lesion stenosis at least 50% in symptomatic patients or at least 70% or evidence of ischemia in asymptomatic patients
- Successful lesion preparation with residual stenosis less than 30% and no complications
- Target lesion in native coronary artery with TIMI grade flow 1 or higher
- Target reference vessel diameter between 2.0 and 4.0 mm
- Target lesion length 36.0 mm or less, coverable by one balloon
- One ISR target lesion treated per patient in a single major coronary artery or side branch
- Other coronary lesions allowed if treated successfully prior to randomization
You will not qualify if you...
- STEMI within 72 hours prior to presentation
- Non-ST elevation ACS with biomarkers not peaked
- PCI within 24 hours before index procedure (except non-target lesions during procedure)
- Prior drug-coated balloon treatment of target lesion ISR
- Cardiogenic shock or requiring hemodynamic support
- Subject is intubated
- Left ventricular ejection fraction less than 30%
- Contraindication to dual antiplatelet therapy for at least 1 month
- Indication for chronic oral anticoagulation with contraindication to P2Y12 inhibitor
- Significant peripheral arterial disease precluding 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
- Renal insufficiency with eGFR less than 30 ml/min
- Active peptic ulcer or active bleeding requiring medical attention within 8 weeks
- History of bleeding disorders or refusal of blood transfusions
- Cerebrovascular accident within 3 months or permanent neurological defect from stroke
- Known allergy to study device components or required medications
- Co-morbid conditions reducing compliance or life expectancy under 24 months
- Participation in another investigational drug or device trial not completed
- Pregnant or breastfeeding women, or intending pregnancy within 12 months
- Organ transplant recipient or listed for transplant
- Recent or planned chemotherapy
- Current oral or intravenous immunosuppressive therapy or life-limiting immunosuppressive/autoimmune disease
- More than one ISR lesion in target vessel not treatable by single balloon
- ISR lesion in segment with prior bare metal stent
- Unprotected left main lesions over 50% or left main intervention
- Primary PCI for STEMI
- Coronary artery disease better treated by surgery
- Lesions likely to require PCI within 12 months after index procedure
- Prior brachytherapy or drug-coated balloon treatment of target lesion
- Bifurcation restenosis involving both branches with side branch diameter over 2.0 mm
- Lesions in arterial or vein grafts or distal to diseased grafts
- Lesions with large thrombus or heavy calcification
- Chronic total occlusions without adequate preparation or TIMI 3 flow
- Diffuse distal disease with impaired runoff
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 locations
1
Cardiology, PC - Princeton Baptist Medical Center
Birmingham, Alabama, United States, 35211
Actively Recruiting
2
Dignity Health - Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297
Actively Recruiting
3
Cedars - Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
4
Yale University / Yale New Haven Hospital
New Haven, Connecticut, United States, 06519
Actively Recruiting
5
Cheek-Powell Heart and Vascular Pavilion
Clearwater, Florida, United States, 33756
Actively Recruiting
6
Clearwater Cardiovascular and Interventional Consultants
Clearwater, Florida, United States, 33756
Actively Recruiting
7
The Cardiac & Vascular Institute Research Foundation
Gainesville, Florida, United States, 32605
Actively Recruiting
8
Tampa General Hospital / University of South Florida
Tampa, Florida, United States, 33606
Actively Recruiting
9
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
Actively Recruiting
10
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
11
Metropolitan Heart and Vascular Institute
Coon Rapids, Minnesota, United States, 55433
Not Yet Recruiting
12
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
13
Cardiology Associates Research, LLC
Tupelo, Mississippi, United States, 38801
Actively Recruiting
14
Cardiology Associates Research, LLC
Tupelo, Mississippi, United States, 38801
Actively Recruiting
15
AtlantiCare Regional Medical Center
Pomona, New Jersey, United States, 08240
Actively Recruiting
16
VA New York Harbor Healthcare System
New York, New York, United States, 10010
Actively Recruiting
17
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
18
Columbia University Medical Center/NYPH
New York, New York, United States, 10032
Actively Recruiting
19
Montefiore Medical Center - Moses Division
The Bronx, New York, United States, 10467
Actively Recruiting
20
NC Heart and Vascular Research, LLC
Raleigh, North Carolina, United States, 27607
Not Yet Recruiting
21
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
22
Oklahoma University Health (OU Health)
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
23
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
24
Prisma Health
Greenville, South Carolina, United States, 29605-5601
Actively Recruiting
25
Centennial Medical Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
26
Baylor Scott and White Heart and Vascular Hospital
Dallas, Texas, United States, 75226
Actively Recruiting
27
Baylor Scott & White - The Heart Hospital - Plano
Plano, Texas, United States, 75093
Actively Recruiting
28
West Virginia University and Vascular Institute
Morgantown, West Virginia, United States, 26506
Actively Recruiting
Research Team
D
Dario Gattuso
CONTACT
F
Farhana Siddique
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here