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

SexALL

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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.
✕. Left main disease \>50% requiring stenting or surgical intervention.
✕. Presence of thrombus or severe vessel calcification that prevents adequate balloon expansion.
✕. Previous stenting at the target lesion within the previous 3 months.
✕. Known allergy or contraindication to sirolimus, contrast media, or dual antiplatelet therapy.
✕. Pregnant or breastfeeding women.
✕. Life expectan

What they're measuring

Composite Measure of Major Adverse Cardiac Events (MACE) at 12 Months including Cardiac Death, Myocardial Infarction, and Clinically Driven Target Lesion Revascularization

Timeframe: 12 Months

Trial details

NCT IDNCT07326735

SponsorFrisch Medical Device Private Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-22

View on ClinicalTrials.gov More Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)) trials