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

Frisch Medical Device Private Limited

Status and phase: Completed; Phase 4

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

Treatments: Device: Mamba Sirolimus-Eluting PTCA Balloon; Device: Percutaneous Coronary Angioplasty with Sirolimus-Coated Balloon

Study type: Interventional

Funder types: Industry

Identifiers

NCT07326735

MIRAGE-DCB-2023-01 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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360 participants in 1 patient group

Mamba Sirolimus Drug-Coated Balloon (DCB)

Experimental group

Description:

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.

Treatment:

Device: Percutaneous Coronary Angioplasty with Sirolimus-Coated Balloon

Device: Mamba Sirolimus-Eluting PTCA Balloon