MIRAGE Study: Clinical Outcomes of the… | Clinical Trial

Key information

Conditions

Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)) Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Color Vision Defects Cone Dystrophy Coronary Artery Disease Coronary Disease Eye Diseases Eye Diseases, Hereditary Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vascular Diseases Vision Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Prime Heart Institute, Yangon, Gujarat, Burma

About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mamba Sirolimus-Eluting PTCA Balloon

Device

PTCA coronary angioplasty with Drug coated balloon for De novo and in stent restenosis cases

Percutaneous Coronary Angioplasty with Sirolimus-Coated Balloon

Device

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.

Primary outcomes

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

Time frame: 12 Months

MACE is defined as the composite rate of cardiac death, myocardial infarction, or clinically driven target lesion revascularization occurring within 12 months following the index procedure.

Sponsors and collaborators

Lead sponsor

Frisch Medical Device Private Limited

Industry

Registry information

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jan 8, 2026
Registry last updated: Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed