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

Frisch Medical Device Private Limited360 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

360

Conditions

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

Interventions

Mamba Sirolimus-Eluting PTCA BalloonDEVICE

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

Percutaneous Coronary Angioplasty with Sirolimus-Coated BalloonDEVICE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18 years or older. 2. Patient diagnosed with obstructive coronary artery disease suitable for percutaneous coronary intervention. 3. Target lesion located in a native coronary artery with reference vessel diameter of ≥2.0 mm. 4. Successful lesion preparation prior to DCB treatment (defined by \<30% residual stenosis and TIMI flow ≥2). 5. Patient able and willing to comply with scheduled follow-up evaluations at 1, 6, and 12 months. 6. Signed informed consent obtained prior to the procedure. Exclusion Criteria: 1. ST-elevation myocardial infarction (STEMI) within the previous 48 hours. 2. Left main disease \>50% requiring stenting or surgical intervention. 3. Presence of thrombus or severe vessel calcification that prevents adequate balloon expansion. 4. Previous stenting at the target lesion within the previous 3 months. 5. Known allergy or contraindication to sirolimus, contrast media, or dual antiplatelet therapy. 6. Pregnant or breastfeeding women. 7. Life expectan

Locations (2)

Prime Heart Institute

Yangon, Gujarat, Burma

National Heart Centre Malaysia

Kuala Lumpur, Malaysia

Outcomes

Primary Outcomes

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

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.

Time frame: 12 Months

Data from ClinicalTrials.gov

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