Clinical Trial

MIRAGE Study: Clinical Outcomes of the Mamba Sirolimus-Eluting PTCA Balloon

Completed Phase 4
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-24.
Trial Details
NCT Number NCT07326735
Lead Sponsor Frisch Medical Device Private Limited
Conditions Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Enrollment 360 participants
Start Date 2023-01-11
Primary Completion 2024-01-22 (estimated)
Study Completion 2024-03-03 (estimated)
Updated on ClinicalTrials.gov 2026-03-11