MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions
NCT ID: NCT05908331
Last Updated: 2025-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
492 participants
INTERVENTIONAL
2024-04-16
2028-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels
NCT06271590
TReAtmeNt of Small Coronary Vessels: MagicTouch Sirolimus Coated Balloon
NCT03913832
MagicTouch Sirolimus Drug Coated Balloon Catheter for the Treatment of Coronary Lesions
NCT02400632
Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels
NCT04893291
Sirolimus-Eluting Stent vs. Intravascular Brachytherapy in In-Stent Restenotic Coronary Artery Lesions(SISR)
NCT00231257
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
One pre-procedure and all post-procedure biomarker blood draws will be sent to a central core laboratory for analysis of troponin T. Evaluation of post-procedural biomarker blood draws in local laboratories are not mandated but may be performed as part of standard of care.
During the index hospitalization, patients will undergo a clinical assessment and 12-lead ECG; and they will have cardiac biomarkers drawn before the intervention to establish baseline biomarker level and confirmation that the biomarkers are falling. At least one post procedure biomarker (core lab) will be drawn at a minimum of 4 hours after PCI as part of the assessment of periprocedural myocardial infarction and significant periprocedural myocardial injury (at 6-8 hour intervals depending on whether the patient remains admitted). If no procedural complications have occurred and there are no signs of ischemia on post-procedure ECG or clinical assessment, the patient may be discharged per local practice and no additional biomarker levels need to be drawn (beyond the protocol-mandated core laboratory draw at a minimum of 4 hours). If the patient remains admitted cardiac biomarkers (core lab) should be drawn every 6-8 hours until at least 2 total post-procedural core laboratory biomarker draws have passed or clinical standard-based biomarker levels have peaked per local labs or the patient is discharged.
After hospital discharge, subjects will be followed at 30 days (+1 week), 6 months (+2 weeks), and 12 months (+1 month) and then 24, 36, 48 and 60 months (+1 month) post procedure. Yearly vital status information will be collected by telephone follow-up. At the 12-month visit, subjects will undergo 12-lead ECG, blood count, coagulation profile and blood chemistry tests. New and ongoing AEs and concomitant medications will also be assessed.
All elective angiograms performed on the target vessel during the 12-month follow-up period should be preceded by a physician evaluation, during which the physician will indicate whether the subject's clinical status warrants revascularization, i.e. the subject has clinical evidence of ischemia. All films, including unscheduled angiograms, are to be sent to the angiographic core laboratory for review. The angiographic core laboratory will be blinded.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MagicTouch Sirolimus-Coated Balloon
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.
Sirolimus Drug Coated Balloon
Magic TouchTM (Concept Medical) is a semi-compliant sirolimus drug coated balloon (SCB) for PCI, based on a polymer-free and nanocarrier based drug delivery technology.
POBA
plain old balloon angioplasty
Plan balloon Angioplasty (POBA)
Plan balloon used to open clogged or narrow coronary arteries due to underlying atherosclerosis
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sirolimus Drug Coated Balloon
Magic TouchTM (Concept Medical) is a semi-compliant sirolimus drug coated balloon (SCB) for PCI, based on a polymer-free and nanocarrier based drug delivery technology.
Plan balloon Angioplasty (POBA)
Plan balloon used to open clogged or narrow coronary arteries due to underlying atherosclerosis
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment
3. Patient with an indication for PCI due to suspected in-stent restenosis
4. Non-target lesion PCI are allowed in non-target vessels to be treated with approved interventional devices prior to randomization as follows:
1. In-stent restenosis after drug-eluting stent implantation(s) in the target lesion (i.e. single and multiple stent layer ISR cases are eligible)
2. Target lesion must have visually estimated stenosis ≥50% and less than 100% diameter stenosis in symptomatic patients; or a visually estimated target lesion diameter stenosis of ≥70%, or by evidence of ischemia by coronary physiology (fractional flow reserve \[FFR\] ≤0.80 or non-hyperemic pressure ratio \[NHPR\] ≤0.89) in absence of symptoms
3. Successful lesion preparation (residual stenosis \<30%), without complications (no or slow flow, flow-limiting dissection, perforation, distal embolization) and without plan for stenting
4. Target lesion in a native coronary artery
5. Thrombolysis In Myocardial Infartction (TIMI) grade flow ≥1 in target lesion
6. Target reference vessel diameter (visual estimation) \>2.0 and ≤4.0 mm
7. Target lesion length (including tandem lesions) ≤36.0 mm (visual estimation) and can be covered by only one balloon
8. One ISR target lesion (overlapping stents are allowed) to be treated per patient and in single major coronary artery or side branch (reference vessel diameter \>2.0 mm)
9. Other coronary lesions (ISR or non-ISR) in non-target vessel are allowed and may be treated by any approved interventional device, but must be treated successfully prior to randomization
Exclusion Criteria
2. NSTEACS in whom the biomarkers have not peaked
3. PCI within the 24 hours prior to the index procedure (not including PCI performed in non-target lesions during the index procedure)
4. Prior DCB treatment (coronary or off-label peripheral) of target lesion ISR
5. Cardiogenic shock (defined as persistent hypotension \[systolic blood pressure \<90 mm Hg\] or requiring vasoactive or hemodynamic support, including IABP)
6. Subject is intubated
7. Known left ventricular ejection fraction \<30%
8. Relative or absolute contraindication to 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. Renal insufficiency as defined by estimated glomerular filtration rate (eGFR) to be \<30ml/min by the MDRD formula
17. Active peptic ulcer or active bleeding from any site
18. Bleeding from any site requiring active medical attention within the prior 8 weeks
19. History of bleeding diathesis or coagulopathy or likely to refuse blood transfusions
20. Cerebrovascular accident (CVA) within 3 months or has any permanent neurological defect as a result of CVA
21. Known allergy to the study device components or protocol-required concomitant medications:
\- sirolimus (as well as other limus drugs, analogues, or similar compounds), aspirin, clopidogrel and prasugrel and ticagrelor, heparin and bivalirudin, or iodinated contrast that cannot be adequately pre-medicated
22. Any co-morbid condition that may cause non-compliance with the protocol (e.g. dementia, substance abuse, etc.) or reduce life expectancy to \<24 months (e.g. cancer, heart failure, lung disease, severe valvular disease)
23. Patient is participating in or plans to participate in any other investigational drug or device trial that has not reached its primary endpoint
24. Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test within one week before index procedure)
25. Women who intend to become pregnant within 12 months after the index procedure
26. Patient has received an organ transplant or is on a waiting list for an organ transplant
27. Patient has received chemotherapy within 30 days before the index procedure or scheduled to receive chemotherapy any time after the index procedure
28. Patient is receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease. Inhaled steroid and steroid use for contrast- allergy prophylaxis or treatment are allowed
1. More than 1 ISR lesion in the target vessel in segments that cannot be treated by a single 40mm length DCB (see Angiographic Inclusions #5 and #6 above)
2. ISR lesion in the target vessel in a segment that corresponds to a previously established/documented bare metal stent (BMS)
3. Unprotected left main lesions \>50% or left main intervention
4. Primary PCI for STEMI
5. Coronary artery disease judged more suitable for surgical revascularization per guidelines and local heart team discussion
6. Another lesion in either the target vessel or non-target vessel is present that requires or has a high probability of requiring PCI within 12 months after the index procedure
7. Prior brachytherapy or DCB treatment of target lesion
8. Target lesion is a bifurcation restenosis involving both branches of a bifurcation in which the side branch reference vessel diameter is \>2.0 mm
9. Target lesions located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
10. Target lesion contains large thrombus
11. Target lesion is heavily calcified
12. Target lesion is a chronic total occlusion (or subtotal) without adequate lesion preparation.\* Total and subtotal occlusions may be enrolled assuming they can be crossed with a wire and demonstrate TIMI grade 3 flow at the time of randomization.
13. Diffuse distal disease to target lesion with impaired runoff
18 Years
110 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cardiovascular Research Foundation, New York
OTHER
Concept Medical Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cardiology, PC - Princeton Baptist Medical Center
Birmingham, Alabama, United States
Dignity Health - Mercy Gilbert Medical Center
Gilbert, Arizona, United States
Cedars - Sinai Medical Center
Los Angeles, California, United States
Yale University / Yale New Haven Hospital
New Haven, Connecticut, United States
Cheek-Powell Heart and Vascular Pavilion
Clearwater, Florida, United States
Clearwater Cardiovascular and Interventional Consultants
Clearwater, Florida, United States
The Cardiac & Vascular Institute Research Foundation
Gainesville, Florida, United States
Tampa General Hospital / University of South Florida
Tampa, Florida, United States
Atlanta VA Medical Center
Decatur, Georgia, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Metropolitan Heart and Vascular Institute
Coon Rapids, Minnesota, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Cardiology Associates Research, LLC
Tupelo, Mississippi, United States
Cardiology Associates Research, LLC
Tupelo, Mississippi, United States
AtlantiCare Regional Medical Center
Pomona, New Jersey, United States
VA New York Harbor Healthcare System
New York, New York, United States
NYU Langone Health
New York, New York, United States
Columbia University Medical Center/NYPH
New York, New York, United States
Montefiore Medical Center - Moses Division
The Bronx, New York, United States
NC Heart and Vascular Research, LLC
Raleigh, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oklahoma University Health (OU Health)
Oklahoma City, Oklahoma, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Prisma Health
Greenville, South Carolina, United States
Centennial Medical Center
Nashville, Tennessee, United States
Baylor Scott and White Heart and Vascular Hospital
Dallas, Texas, United States
Baylor Scott & White - The Heart Hospital - Plano
Plano, Texas, United States
West Virginia University and Vascular Institute
Morgantown, West Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Bernardo Stein
Role: primary
Barry Bertolet
Role: primary
Natalie S. Massenburg
Role: primary
Ajay Kirtane
Role: primary
Azeem Latib
Role: primary
Josh Bomabrd
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CM-US-R02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.