NCT04523168已完成不适用
A Phase II Study Testing the Feasibility and Efficacy of Coronary Sinus Narrowing in Patients With Coronary Microvascular Dysfunction
Amir Lerman2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年6月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Coronary Flow Reserve (CFR)
研究概览
简要总结
This study is being done to evaluate the role of a novel implantable device, called The Neovasc Reducer™ System, in improving microvascular function, symptoms and quality of life in symptomatic patients with coronary microvascular dysfunction.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Coronary Flow Reserve (CFR)
时间窗: Baseline, 120 days
Coronary flow reserve is calculated as the ratio of hyperemic or maximal flow down a coronary vessel to the resting coronary blood flow.
次要结局
- Change in Canadian Cardiovascular Society (CCS) Angina Class(Baseline, 120 days)
- Seattle Angina Questionnaire (SAQ)(120 days)
研究者
Amir Lerman
Principal Investigator
Mayo Clinic
研究点 (2)
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