What is the MagicTouch sirolimus-coated balloon studying for in-stent restenosis?

The MagicTouch sirolimus-coated balloon is being studied to evaluate its safety and effectiveness in treating coronary in-stent restenosis, a condition where previously placed stents narrow again. Researchers want to see if this device improves outcomes compared to standard balloon angioplasty. The study is sponsored by Concept Medical Inc. and involves patients undergoing PCI for ISR.

Who may be eligible for this in-stent restenosis clinical trial?

Adults aged 18 to 110 years who have had drug-eluting stent implantation and now have suspected in-stent restenosis needing PCI may be eligible. The study includes all genders and requires meeting specific heart function and health criteria. Please review eligibility criteria for more details.

Is there any cost to participate in this in-stent restenosis clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered during the trial.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 110Years

All Genders

ID05908331

Study of MagicTouch Sirolimus-Coated Balloon Compared to Balloon Angioplasty for Treating In-Stent Restenosis in Coronary Artery Disease

Led by Concept Medical Inc. · Updated on 2025-02-25

492

Participants Needed

Research Sites

147 weeks

Total Duration

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 21 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

Age: 18Years - 110Years

All Genders

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

Research Team

Dario Gattuso

Farhana Siddique

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Study of MagicTouch Sirolimus-Coated Balloon Compared to Balloon Angioplasty for Treating In-Stent Restenosis in Coronary Artery Disease

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria