The E-SERIES Registry for Supralimus® Coronary Stent for the Treatment of Unselected Patients With Coronary Lesions
A Prospective, Multinational Investigation of the Supralimus® Sirolimus-Eluting Stent for the Treatment of Unselected Patients With Coronary Lesions in the "Real- World" Clinical Practice
研究概览
详细说明
E-SERIES Registry is Prospective, multinational (Asia, South America and Europe), non-randomized, post-marketing web-based registry.
For this Study Up to 100 clinical sites in Asia, South America and Europe. Patients "ALL COMERS" assigned for percutaneous coronary interventions who present with at least one angiographically documented coronary artery lesion suitable for percutaneous treatment with the Supralimus® SES.
All subjects who provided signed informed consent prior to procedure, and have at least one lesion in a major epicardial vessel or major branch (>2.25mm), and are suitable for percutaneous treatment including stenting procedure with the Supralimus® SES. There are no limit regarding the number of lesions and/or study stents to be used, and stenting technique will be left at the operator's discretion; however, it is recommended according to the BEST interventional practice according to the current guidelines.
All patients will undergo follow-up clinical evaluation at 1, 6, 12 and 24 months. Angiographic follow-up will be performed at 6 months in a subset of high risk lesions including bifurcations (first 100 lesions) and left main stem (first 100 lesions).
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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São Paulo、巴西、05022-001
- Hospital São Camilo
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Espírito Santo
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Vitória、Espírito Santo、巴西、29047-575
- CIAS- Unimed Vitória
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Goiás
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Goiânia、Goiás、巴西、74823-320
- Centro de Cardiologia e Radiologia
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Minas Gerais
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Belo Horizonte、Minas Gerais、巴西、30380-090
- Hospital Luxemburgo
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Juiz de Fora、Minas Gerais、巴西、36025-550
- Hospital Monte Sinai
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Paraná
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Curitiba、Paraná、巴西
- Hospital Vita
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Sao Paulo
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Botucatu、Sao Paulo、巴西
- H.C.Unesp
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- CLINICAL INCLUSION CRITERIA: Patients >18 years, clinical indication for elective or emergency percutaneous coronary intervention with stent implantation of at least one angiographically documented coronary artery lesion; agreement to undergo ALL study protocol follow-ups.
- ANGIOGRAPHIC INCLUSION CRITERIA: Diseased coronary vessels with at least one lesion with ≥50% diameter stenosis by visual estimation in a major epicardial vessel or a major branch (>2.25mm) with anatomy suitable for percutaneous treatment with the Supralimus SES.
Exclusion Criteria:
- CLINICAL EXCLUSION CRITERIA: Known illness with life expectancy <12 months; impossibility to comply with all protocol follow-ups.
- ANGIOGRAPHIC EXCLUSION CRITERIA: Anatomy unsuitable for percutaneous treatment with implantation of the Supralimus SES.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Supralimus® Sirolimus-Eluting Coronary Stent
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Supralimus® Coronary Stent System consisting of the MATRIX® Coronary Stent having Sirolimus eluting from Biodegradable Polymeric Matrix on a Stainless Steel Platform, Drug concentration 1.4 µg/mm2
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
MAJOR ADVERSE CARDIAC EVENTS (MACE)
大体时间:12 months
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12 months
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次要结果测量
结果测量 |
大体时间 |
---|---|
Rates of procedural success
大体时间:24 month
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24 month
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Rates of Major Adverse Cardiac Event (MACE)
大体时间:In-hospital, 30 days, 6 and 24 months
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In-hospital, 30 days, 6 and 24 months
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Rates of target lesion revascularization (TLR)
大体时间:6 and 12 months
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6 and 12 months
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Rates of stent thrombosis (acute, sub-acute, late and very-late)
大体时间:Up to 24 months follow-up
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Up to 24 months follow-up
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合作者和调查者
调查人员
- 首席研究员:Alexandre Abizaid,, MD、Instituto Dante Pazzanese de Cardiologia São Paulo, SP, Brazil
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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