Impact of the Coronary Sinus Reducer on Coronary Flow Reserve and Symptoms in Patients With Coronary Microvascular Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- UMC Utrecht
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Change in coronary flow reserve
研究概览
简要总结
Coronary microvascular dysfunction (CMD) is a common cause of treatment- resistant angina that lacks evidence-based treatment options. The coronary sinus reducer (CSR) is an hourglass-shaped stainless steel mesh, designed to create a controlled narrowing of the coronary sinus (CS). By augmenting CS pressure, CSR implantation was shown to improve myocardial perfusion, potentially providing a novel treatment for patients with CMD. REDUCE CMD is a placebo-controlled study of CSR in 50 patients with CMD. The main study endpoints are the change in coronary flow reserve from baseline to 6 months in the CSR-arm versus the placebo arm, and the difference in number of daily episodes of angina recorded on the ORBITA-app at 6 month follow-up in the CSR-arm versus the placebo arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary microvascular dysfunction in the left anterior descending coronary artery (LAD) as expressed by abnormal absolute coronary flow reserve (CFR<2.5) confirmed during the index study procedure using the continuous thermodilution technique and saline-induced coronary hyperaemia.
- •Angina - Canadian Cardiovascular Society Class II-IV on at least two anti-anginals or maximally tolerated medical therapy if less than two.
- •Patient understands the nature of the procedure and provides written informed consent for the study prior to enrolment.
排除标准
- •Age < 18 years.
- •Absence of symptoms reported on the ORBITA-app during the 2-week screening period.
- •Presence of hemodynamically significant epicardial stenoses based on both non- hyperaemic pressure ratio (NHPR; iFR≤0.89, or RFR≤0.89, or dFR/dPR≤0.89) or fractional flow reserve (FFR≤0.80) assessments.
- •Prior positive acetylcholine provocation test with respect to epicardial vasospasm following the COVADIS criteria.
- •Mean right atrial pressure ≥15 mmHg
- •Severe pulmonary hypertension.
- •Coronary sinus anatomy not suitable for CSR implantation.
- •Pregnancy or planned pregnancy within the next 12 months.
- •Recent acute coronary syndrome (within 3 months).
- •Recent revascularization with PCI (within 6 months).
- •Severe arrhythmias, including chronic atrial fibrillation with persistent rapid ventricular response (>100bpm despite medication).
- •Indication for cardiac resynchronization therapy.
- •Severe left ventricular impairment (left ventricular ejection fraction <35%).
- •NYHA class IV or decompensated heart failure or hospitalization due to heart failure within 90 days before the index procedure.
- •Recent implantation of a permanent pacemaker or defibrillator lead in the right ventricle or atrium (within 90 days before the index procedure).
- •Presence of a pacemaker lead in the coronary sinus.
- •Severe valvular heart disease.
- •History of tricuspid valve replacement or repair.
- •Contra-indication to short term dual antiplatelet therapy or lifelong aspirin treatment.
- •Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
- •Known inability to tolerate contrast medium.
- •Life expectancy <1 year.
结局指标
主要结局
Change in coronary flow reserve
时间窗: 6 months
Change in coronary flow reserve from baseline to 6 months in the CSR-arm versus the placebo arm (measured by the continuous flow thermodilution technique using saline-induced coronary hyperaemia).
Angina episodes
时间窗: 6 months
Difference in number of daily episodes of angina recorded on the ORBITA-app at 6 month follow-up in the CSR-arm versus the placebo arm.
次要结局
未报告次要终点
研究者
Tim P. van de Hoef
Principal Investigator
UMC Utrecht