MIRAGE Study: Clinical Outcomes of the Mamba Sirolimus-Eluting PTCA Balloon
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Composite Measure of Major Adverse Cardiac Events (MACE) at 12 Months including Cardiac Death, Myocardial Infarction, and Clinically Driven Target Lesion Revascularization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Mamba Sirolimus-Eluting PTCA Balloon (Device)
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.
干预措施: Percutaneous Coronary Angioplasty with Sirolimus-Coated Balloon (Device)
结局指标
主要结局
Composite Measure of Major Adverse Cardiac Events (MACE) at 12 Months including Cardiac Death, Myocardial Infarction, and Clinically Driven Target Lesion Revascularization
时间窗: 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.
次要结局
未报告次要终点