Actively Recruiting
MagicTouch Sirolimus-coated Balloon 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
147 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
Researchers are evaluating the safety and effectiveness of the MagicTouch14 Sirolimus-coated balloon compared to plain old balloon angioplasty (POBA) in treating coronary in-stent restenosis (ISR), which occurs when previously placed drug-eluting stents become narrowed again. This prospective, randomized, two-arm, single-blind superiority trial involves subjects with prior drug-eluting stent implantation who require percutaneous coronary intervention (PCI) for ISR. The study aims to establish whether the MagicTouch device improves treatment outcomes for coronary artery lesions. Participants will be randomly assigned in a 2:1 ratio to receive either the MagicTouch Sirolimus-coated balloon or POBA during PCI to treat the ISR lesion. Before treatment, patients undergo medical history review, physical exams, lab tests, and ECGs. Blood samples will be collected before and after the procedure to assess cardiac biomarkers such as troponin T. During hospitalization, patients receive clinical assessments and ECGs; biomarker samples are taken at specified intervals to monitor heart muscle injury. After discharge, patients have follow-up visits at 30 days, 6 months, 12 months, and annually up to 5 years, which include ECGs, blood tests, medication reviews, and adverse event monitoring. Angiograms performed within the first year will be reviewed by a blinded core lab to evaluate lesion status. Participants will be involved in scheduled clinical assessments, laboratory testing, and imaging evaluations to track heart function and treatment outcomes. Researchers will measure the primary outcome of target lesion failure at 12 months and multiple secondary outcomes related to cardiovascular events, revascularization, mortality, myocardial infarction, bleeding, and procedural success up to 5 years. The study includes safety monitoring through biomarker analysis and ECGs during hospitalization and detailed follow-up visits extending through 60 months post-procedure to assess long-term effects.
CONDITIONS
Brief 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
- Provides written informed consent and understands the trial requirements
- Has an indication for PCI due to suspected in-stent restenosis
- Non-target lesion PCI allowed in non-target vessels prior to randomization
- In-stent restenosis after drug-eluting stent implantation in target lesion
- Target lesion stenosis 50% and less than 100% in symptomatic patients, or 70% or ischemia evidence in asymptomatic
- Successful lesion preparation with residual stenosis less than 30% and no complications
- Target lesion in a native coronary artery with TIMI grade flow 1
- Target vessel diameter between 2.0 and 4.0 mm
- Target lesion length 36.0 mm treatable by one balloon
- One ISR target lesion to be treated per patient in a single major artery or side branch
- Other coronary lesions allowed if treated successfully before randomization
You will not qualify if you...
- STEMI within 72 hours before treatment
- NSTEACS with biomarkers not peaked
- PCI within 24 hours prior to index procedure (except non-target lesions during procedure)
- Prior drug-coated balloon treatment of target lesion ISR
- Cardiogenic shock or intubation
- Left ventricular ejection fraction less than 30%
- Contraindication to dual antiplatelet therapy for at least one month
- Need for chronic oral anticoagulation with contraindication to P2Y12 inhibitors
- Significant peripheral arterial disease affecting femoral access
- Hemoglobin less than 9 g/dL
- Platelet count less than 100,000 or more than 700,000 cells/mm3
- White blood cell count less than 3,000 cells/mm3
- Active infection under treatment
- Significant liver disease or renal insufficiency (eGFR <30 ml/min)
- Active peptic ulcer or recent bleeding
- History of bleeding disorders or refusal of transfusions
- Recent cerebrovascular accident or permanent neurological defects
- Allergies to study device components or required medications
- Co-morbid conditions reducing life expectancy to less than 24 months
- Participation in other investigational trials without primary endpoint reached
- Pregnancy, breastfeeding, or plans for pregnancy within 12 months
- Organ transplant recipient or on waiting list
- Recent or planned chemotherapy
- Immunosuppressive therapy or life-limiting autoimmune disease
- More than one ISR lesion in target vessel not treatable by single balloon
- ISR lesion involving bare metal stents
- Unprotected left main lesions >50% or left main intervention
- Primary PCI for STEMI
- Coronary disease better suited for surgery
- Lesions likely to require PCI within 12 months
- Prior brachytherapy or drug-coated balloon treatment of target lesion
- Bifurcation restenosis involving both branches with side branch >2.0 mm
- Lesions in grafts or distal to diseased grafts
- Lesions with large thrombus or heavy calcification
- Chronic total occlusion without adequate lesion preparation
- Diffuse distal disease with impaired runoff
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 1 week before the procedure
Participants are screened for eligibility to participate in the trial.
1 screening visit (in-person) within 7 days prior to procedure
Duration - Day of the procedure
Participants undergo treatment by receiving either the MagicTouch sirolimus-coated balloon or plain old balloon angioplasty on the target in-stent restenosis lesion.
1 procedure visit (in-person)
Duration - Hours to days following the procedure until discharge
During the initial hospital stay, participants have clinical assessments, 12-lead ECGs, and multiple blood draws to monitor cardiac biomarkers before and after the intervention to assess myocardial injury.
Multiple assessments and blood draws during hospitalization (in-person)
Duration - 30 days to 60 months post-procedure
Participants are followed for up to 5 years after the procedure with clinic visits to assess health status, perform ECGs and blood tests, and monitor for adverse events and need for further interventions.
Visits at 30 days, 6 months, 12 months, and then annually up to 60 months; yearly telephone follow-ups
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
F
Farhana Siddique
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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