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

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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
• Intervention / Treatment: Device: Mamba Sirolimus-Eluting PTCA Balloon; Device: Percutaneous Coronary Angioplasty with Sirolimus-Coated Balloon

Detailed Description

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
• Enrollment (Actual): 360
• Phase: Phase 4

Contacts and Locations

Study Locations

• Burma
  • Gujarat
    • Yangon, Gujarat, Burma, 380052
      • Prime Heart Institute
• Malaysia
  • Kuala Lumpur, Malaysia
    • National Heart Centre Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mamba Sirolimus Drug-Coated Balloon (DCB); Participants undergo percutaneous coronary angioplasty using the Mamba Sirolimus Drug-Coated Balloon (DCB) following standard lesion preparation. Balloon is inflated 30-45 seconds; multiple inflations permitted. No implant is left behind.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 Months

Collaborators and Investigators

• Sponsor: Frisch Medical Device Private Limited
• Investigators: Study Chair: Bhavin Oza, Frisch Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Actual): January 22, 2024
• Study Completion (Actual): March 3, 2024

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 24, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Drug Coated balloons, DCB , DEB, Sirolimus, de novo , in-stent restenosis lesions
• Additional Relevant MeSH Terms: Cone Dystrophy; Pain; Neurologic Manifestations; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Eye Diseases; Infarction; Necrosis; Eye Diseases, Hereditary; Vision Disorders; Sensation Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Ischemia; Chest Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Coronary Artery Disease; Myocardial Infarction; Angina Pectoris; Color Vision Defects
• Other Study ID Numbers: MIRAGE-DCB-2023-01 (Other Identifier: Frisch Medical Devices Pvt Ltd)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No