Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Conditions
Keywords
Drug Coated balloons, DCB , DEB, Sirolimus, de novo , in-stent restenosis lesions
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.
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.
Interventions
DEVICEMamba Sirolimus-Eluting PTCA Balloon
PTCA coronary angioplasty with Drug coated balloon for De novo and in stent restenosis cases
DEVICEPercutaneous 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.
Sponsors
Frisch Medical Device Private Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Drug coted coronary PTCA balloons
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Measure of Major Adverse Cardiac Events (MACE) at 12 Months including Cardiac Death, Myocardial Infarction, and Clinically Driven Target Lesion Revascularization | 12 Months | 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. |
Countries
Burma, Malaysia
Contacts
STUDY_CHAIRBhavin Oza
Frisch Medical Devices
Outcome results
None listed