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

NCT07326735 | Completed Phase 4 DMC

• 1 other identifier: MIRAGE-DCB-2023-01
• Study Type: interventional
• Target: 360
• Locations: 2 countries
• Sites: 2

Brief 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))

Keywords

Drug Coated balloons, DCB , DEB, Sirolimus, de novo , in-stent restenosis lesions

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Mamba Sirolimus Drug-Coated Balloon (DCB)

EXPERIMENTAL

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; Device: Percutaneous Coronary Angioplasty with Sirolimus-Coated Balloon

Interventions

Mamba Sirolimus-Eluting PTCA Balloon DEVICE

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

Mamba Sirolimus Drug-Coated Balloon (DCB)

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.

Mamba Sirolimus Drug-Coated Balloon (DCB)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Frisch Medical Device Private Limited: lead

Study Sites (2)

Prime Heart Institute

Yangon, Gujarat, 380052, Burma

Location

National Heart Centre Malaysia

Kuala Lumpur, Malaysia

Location

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Myocardial Infarction; Color Vision Defects

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis; Vision Disorders; Sensation Disorders; Nervous System Diseases; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases

Study Officials

• Bhavin Oza

  Frisch Medical Devices

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Drug coted coronary PTCA balloons

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 8, 2026
• Study Start: January 11, 2023
• Primary Completion: January 22, 2024
• Study Completion: March 3, 2024
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

MY (1); BU (1)