MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions

Recruiting now · Not applicable

Conditions studied: In-Stent Restenosis, Cardiovascular Diseases, Coronary Artery Disease

In brief

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).

Key facts

Study ID

NCT05908331

Run by

Concept Medical Inc.

People needed

492

Starts

2024-04-16

Expected to finish

2028-07-01

Last updated by the study team

2025-02-25

Who can join

Age: 18 and older, up to 110. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is at least 18 years old
• Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment
• Patient with an indication for PCI due to suspected in-stent restenosis
• Non-target lesion PCI are allowed in non-target vessels to be treated with approved interventional devices prior to randomization as follows:
• Angiographic Inclusion Criteria:
• In-stent restenosis after drug-eluting stent implantation(s) in the target lesion (i.e. single and multiple stent layer ISR cases are eligible)
• 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
• Successful lesion preparation (residual stenosis <30%), without complications (no or slow flow, flow-limiting dissection, perforation, distal embolization) and without plan for stenting
• Target lesion in a native coronary artery
• Thrombolysis In Myocardial Infartction (TIMI) grade flow ≥1 in target lesion
• Target reference vessel diameter (visual estimation) >2.0 and ≤4.0 mm
• Target lesion length (including tandem lesions) ≤36.0 mm (visual estimation) and can be covered by only one balloon
• 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)
• 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

You may not qualify if…

• General Exclusion Criteria (all must be absent for the patient to be eligible):
• STEMI within 72 hours of presentation to the first treating hospital, whether a transfer facility or the study hospital
• NSTEACS in whom the biomarkers have not peaked
• PCI within the 24 hours prior to the index procedure (not including PCI performed in non-target lesions during the index procedure)
• Prior DCB treatment (coronary or off-label peripheral) of target lesion ISR
• Cardiogenic shock (defined as persistent hypotension [systolic blood pressure <90 mm Hg] or requiring vasoactive or hemodynamic support, including IABP)
• Subject is intubated
• Known left ventricular ejection fraction <30%
• Relative or absolute contraindication to DAPT for at least 1 month (e.g., planned surgeries that cannot be delayed)
• Subject has an indication for chronic oral anticoagulation treatment and a contraindication for concomitant treatment with a P2Y12 inhibitor
• If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath
• Hemoglobin <9 g/dL
• Platelet count <100,000 cells/mm3 or >700,000 cells/mm3
• White blood cell count <3,000 cells/mm3
• Active infection undergoing treatment
• Clinically significant liver disease
• Renal insufficiency as defined by estimated glomerular filtration rate (eGFR) to be <30ml/min by the MDRD formula
• Active peptic ulcer or active bleeding from any site
• Bleeding from any site requiring active medical attention within the prior 8 weeks
• History of bleeding diathesis or coagulopathy or likely to refuse blood transfusions
• Cerebrovascular accident (CVA) within 3 months or has any permanent neurological defect as a result of CVA
• 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
• 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)
• Patient is participating in or plans to participate in any other investigational drug or device trial that has not reached its primary endpoint

Where it is running

• West Virginia University and Vascular Institute — Morgantown, West Virginia, United States (enrolling)
• Dignity Health - Mercy Gilbert Medical Center — Gilbert, Arizona, United States (enrolling)
• Cedars - Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Yale University / Yale New Haven Hospital — New Haven, Connecticut, United States (enrolling)
• Cheek-Powell Heart and Vascular Pavilion — Clearwater, Florida, United States (enrolling)
• Clearwater Cardiovascular and Interventional Consultants — Clearwater, Florida, United States (enrolling)
• The Cardiac & Vascular Institute Research Foundation — Gainesville, Florida, United States (enrolling)
• Tampa General Hospital / University of South Florida — Tampa, Florida, United States (enrolling)
• Atlanta VA Medical Center — Decatur, Georgia, United States (enrolling)
• Baylor Scott and White Heart and Vascular Hospital — Dallas, Texas, United States (enrolling)
• Baylor Scott & White - The Heart Hospital - Plano — Plano, Texas, United States (enrolling)
• Cardiology, PC - Princeton Baptist Medical Center — Birmingham, Alabama, United States (enrolling)
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (enrolling)
• Cardiology Associates Research, LLC — Tupelo, Mississippi, United States (enrolling)
• Cardiology Associates Research, LLC — Tupelo, Mississippi, United States (enrolling)
• AtlantiCare Regional Medical Center — Pomona, New Jersey, United States (enrolling)
• VA New York Harbor Healthcare System — New York, New York, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• Columbia University Medical Center/NYPH — New York, New York, United States (enrolling)
• Montefiore Medical Center - Moses Division — The Bronx, New York, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Oklahoma University Health (OU Health) — Oklahoma City, Oklahoma, United States (enrolling)
• Providence St. Vincent Medical Center — Portland, Oregon, United States (enrolling)
• Prisma Health — Greenville, South Carolina, United States (enrolling)
• Centennial Medical Center — Nashville, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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