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

U.S., Jan. 9 -- ClinicalTrials.gov registry received information related to the study (NCT07326735) titled 'MIRAGE Study: Clinical Outcomes of the Mamba Sirolimus-Eluting PTCA Balloon' on Dec. 10, 2025.

Brief 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.

Study Start Date: Jan. 11, 2023

Study Type: INTERVENTIONAL

Condition: Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction,...