MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions (NCT05908331) | Clinical Trial Compass
RecruitingNot Applicable
MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions
United States492 participantsStarted 2024-04-16
Plain-language summary
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).
Who can participate
Age range
18 Years – 110 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
Exclusion criteria
. 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)