NCT07326735CompletedPhase 4
MIRAGE Study: Clinical Outcomes of the Mamba Sirolimus-Eluting PTCA Balloon
Source: ClinicalTrials.gov · Last updated 11 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 360 (actual)
- First submitted
- 10 Dec 2025
- Start date
- 11 Jan 2023
- Primary completion date
- 22 Jan 2024
- Lead sponsor
- Frisch Medical Device Private Limited
- Diseases
- Coronary artery disease
- NCT number
- NCT07326735
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 360
- From 11 Jan 2023 to the primary completion date, 22 Jan 2024
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- ST-elevation myocardial infarction (STEMI) within the previous 48 hours.
- Previous stenting at the target lesion within the previous 3 months.
Other illness
- Left main disease \>50% requiring stenting or surgical intervention.
- Known allergy or contraindication to sirolimus, contrast media, or dual antiplatelet therapy.
Other
- Presence of thrombus or severe vessel calcification that prevents adequate balloon expansion.
- Pregnant or breastfeeding women.
- Life expectan
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prime Heart Institute Coordinator of this site? Confirm its status | Yangon | Myanmar (Burma) | Unknown status |
| National Heart Centre Malaysia Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.