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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-11

Study Completion Date

2024-03-03

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Drug coted coronary PTCA balloons

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mamba Sirolimus-Eluting PTCA Balloon

Intervention Type DEVICE

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

Percutaneous Coronary Angioplasty with Sirolimus-Coated Balloon

Intervention Type 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.

Interventions

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Mamba Sirolimus-Eluting PTCA Balloon

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

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No