A single-arm, single-centre, observational study to assess the efficacy of MeRes100™ Sirolimus Eluting BioResorbable Vascular Scaffold System by CT angiogram in patients with coronary artery disease.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Area stenosis
研究概览
简要总结
This is a prospective, single-arm, single-centre study to evaluate the CT angiographic outcomes after implantation of MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System in patients with coronary artery disease. The objective of this study is to assess vessel patency, luminal dimensions, and presence of in-scaffold obstruction using CT angiography after MeRes100 BRS implantation. The safety and efficacy of MeRes100 BRS has been previously established in the MeRes-1 and MeRes-1 Extend trials, which reported sustained safety and clinical performance up to three years. Two-year outcomes showed favourable angiographic results with a low rate of target lesion failure and no definite or probable scaffold thrombosis. CT angiography has demonstrated good diagnostic accuracy in detecting in-scaffold luminal obstruction and measuring luminal dimensions post implantation. Studies suggest that CT angiography and conventional coronary angiography offer similar diagnostic accuracy in identifying obstructive coronary artery disease. Therefore, this study aims to further evaluate CT angiographic outcomes in patients treated with MeRes100 BRS.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient who has been implanted with MeRes100 BRS.
- •Patient has given written informed consent for participation prior to enrolment.
- •Patient is willing to undergo all study procedures and follow-up requirements.
排除标准
- •Any condition, which in the Investigator’s opinion would preclude safe participation of patient in the study.
- •Patient participating in another clinical investigation.
结局指标
主要结局
Area stenosis
时间窗: 12 month
Area stenosis is calculated as the reference minus the minimal lumen area
时间窗: 12 month
as a percentage of the reference lumen area. The reference vessel lumen
时间窗: 12 month
area is calculated as the average of the mean proximal and mean distal vessel
时间窗: 12 month
areas
时间窗: 12 month
次要结局
未报告次要终点
研究者
Dr Girish Navasundi
Apollo Hospitals
