Trials / Completed

CompletedNCT07326735

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

Status: Completed
Phase: Phase 4
Study type: Interventional
Enrollment: 360 (actual)

Sponsor: Frisch Medical Device Private Limited · Industry
Sex: All
Age: —
Healthy volunteers: Not accepted

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.

Detailed description

Conditions

Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))

Interventions

Type	Name	Description
DEVICE	Mamba Sirolimus-Eluting PTCA Balloon	PTCA coronary angioplasty with Drug coated balloon for De novo and in stent restenosis cases
DEVICE	Percutaneous Coronary Angioplasty with Sirolimus-Coated Balloon	Percutaneous transluminal coronary angioplasty performed using a sirolimus-coated balloon catheter intended to deliver the drug to the arterial wall during balloon inflation. The balloon is positioned across the target lesion following standard lesion preparation and inflated for approximately 30-45 seconds; multiple inflations are permitted. No permanent implant or scaffold remains in the artery. The sirolimus coating is designed to inhibit neointimal hyperplasia and support vessel healing, offering a "leave-nothing-behind" approach to treatment of obstructive coronary artery disease.

Timeline

Start date: 2023-01-11
Primary completion: 2024-01-22
Completion: 2024-03-03
First posted: 2026-01-08
Last updated: 2026-03-11

Locations

2 sites across 2 countries: Burma, Malaysia

Source: ClinicalTrials.gov record NCT07326735. Inclusion in this directory is not an endorsement.