MIRAGE Study: Clinical Outcomes of the Mamba Sirolimus-Eluting PTCA Balloon (NCT07326735) | Clinical Trial Compass
CompletedPhase 4
MIRAGE Study: Clinical Outcomes of the Mamba Sirolimus-Eluting PTCA Balloon
Burma, Malaysia360 participantsStarted 2023-01-11
Plain-language summary
This Clinical Evaluation Report (CER) covers the Mamba Sirolimus-Eluting PTCA Balloon catheter intended for the treatment of coronary artery disease in de novo or in-stent restenosis lesions. It includes analysis of clinical data from the MIRAGE clinical study, literature data on sirolimus DCBs, bench and preclinical testing, and risk-benefit evaluation in compliance with MDR Annex XIV.
Who can participate
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
. Age 18 years or older.
. Patient diagnosed with obstructive coronary artery disease suitable for percutaneous coronary intervention.
. Target lesion located in a native coronary artery with reference vessel diameter of ≥2.0 mm.
. Successful lesion preparation prior to DCB treatment (defined by \<30% residual stenosis and TIMI flow ≥2).
. Patient able and willing to comply with scheduled follow-up evaluations at 1, 6, and 12 months.
. Signed informed consent obtained prior to the procedure.
Exclusion criteria
. ST-elevation myocardial infarction (STEMI) within the previous 48 hours.
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.
1The MIRAGE study used a sirolimus-eluting balloon instead of a stent — can you explain how this drug-coated balloon approach works for coronary artery disease, and whether that might be relevant to my specific situation?
2Since this was a Phase 4 trial that has already completed, does that mean there is published data on the 12-month MACE outcomes — including cardiac death, heart attack, and repeat procedures — that we could review together to understand how patients did?
3The trial enrolled people with conditions like angina, myocardial infarction, and atherosclerotic heart disease — does my diagnosis fall within that range, and how closely do my circumstances match the kinds of patients who were in this study?
4Given that this trial is now completed, is the Mamba sirolimus-eluting balloon currently available as a standard treatment option, or would participating in a study still be the only way to access it?
5Compared to my current treatment path — whether that's medication, a conventional balloon procedure, or a drug-eluting stent — what does my care team think the completed MIRAGE data suggests about where this type of device might or might not be a better fit?
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.
What they're measuring
1
Composite Measure of Major Adverse Cardiac Events (MACE) at 12 Months including Cardiac Death, Myocardial Infarction, and Clinically Driven Target Lesion Revascularization