MedTrace Logo

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

NCT07326735 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-03-11

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Frisch Medical Device Private Limited

    lead INDUSTRY

Principal Investigators

  • Bhavin Oza · Frisch Medical Devices

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-11
Primary Completion
2024-01-22
Completion
2024-03-03

Countries

  • Burma
  • Malaysia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07326735 on ClinicalTrials.gov