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Coronary Sinus Reducer in Patients With Angina With no Obstructive Coronary Disease

RecruitingNAAges 18 Years - anyAllMedical University of Warsaw
NCT07010029 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Even half of patients with angina undergoing invasive coronary angiography presents without any significant epicardial stenosis. In these cases, symptoms are usually caused by coronary microvascular dysfunction (CMD), developing as a result of several potential underlying pathophysiologies. A wide range of underlying pathomechanisms makes it challenging to develop molecular-targeted pharmacological solutions; thus, direct physiology modification has been introduced as a promising concept. The coronary sinus reducer (CSR) narrows the coronary sinus, which causes symptom relief in patients with refractory angina and coronary stenosis. CSR implantation aims to increase the coronary sinus pressure, which raises venous back pressure into the myocardium. Despite several hypotheses, the exact physiological mechanisms remain not fully elucidated. Recent data from observational studies also sugge

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📋 Eligibility rules (as published)
Inclusion Criteria: * Stable angina symptoms without significant obstruction of coronary artery (defined as coronary artery stenosis diameter ≤ 50% or coronary artery stenosis diameter \>50% and ≤70% with FFR\>0.8), with coronary microvascular dysfunction confirmed in invasive test (defined as coronary flow reserve ≤ 2.5 or index of microvascular resistance ≥ 25) * No future options for antianginal therapy (maximum antianginal therapy for at least three months) Exclusion Criteria: * Vasospastic angina (positive test with acetylcholine), * Evidence of cardiac ischemia, * Coronary flow limiting myocardial bridge, * Severe valvular disease * Hospitalization for acute heart failure \< 3 months * Hypertrophic cardiomyopathy, * Ejection fraction ≤ 30%, * Permanent pacemaker or defibrillator leads in the right heart, * Recent acute coronary syndrome \< 6 months, * Recent revascularization \< 2 months, * Right atrial pressure of 15 mmHg or higher, * Severe renal impairment, * Indication for cardiac resynchronization therapy, * Pregnancy, * Life expectancy of less than 1 year, * Inclusion in another clinical trial
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What it tests

  • Coronary Sinus Reducer
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Where

1 site
Medical University of Warsaw
Warsaw, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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