RecruitingNot Applicable

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

Poland50 participantsStarted 2025-05-12

Plain-language summary

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 suggest the beneficial effect of CMD on microvascular indices. To date, there are limited data regarding the efficacy of this solution in patients with angina with no obstructive coronary artery disease (ANOCA). Of note, patients with ANOCA are frequently burdened with other comorbidities, such as heart failure with preserved ejection fraction (HFpEF). HFpEF presence relates to worse prognosis and higher risk of future cardiovascular events. Previous works showed that HFpEF is significantly associated with the appearance of CMD. Due to the small variety of drugs for HFpEF, treatment targeting CMD may be a promising therapeutic target for this disease. To date, there is also no data regarding the impact of CSR implantation on function of left ventricle and echocardiographic indexes impaired in diastolic dysfunction in patients with ANOCA. Proposed study aims to evaluate the CSR as a therapeutic strategy in patients with ANOCA to improve angina, as well as quality of life and will deliver the results regarding CSR impact on diastolic function of left and right ventricle. This study will also evaluate the mechanisms standing behind the benefits of CSR use. Neovasc reducer produced by Shockwave Medical inc will be used as CSR device in this study. Proposed study may lead to the introduction of the Neovasc reducer to the guidelines for ANOCA patients. It will also provide the data on Neovasc reducer potential use as a supportive therapy in patients with HFpEF. Prospective, single-arm cohort study including patients with angina with no obstructive coronary artery disease. Enrolled patients will undergo the Neovasc reducer implantation with periprocedural evaluation of coronary microcirculation before and directly after the device implantation. All patients will be assessed with echocardiography (evaluation by external corelab) at baseline and at six months of follow-up. Patients will also undergo exercise testing (six-minute walk test) and assessment of quality of life (SF-36), as well as angina severity (Seattle Angina Questionnaire, Dedicated app and Canadian Cardiovascular Society grade).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical endpoint - Difference in summary Seattle Angina Questionnaire results between follow-up and baseline

Timeframe: 6 months

Mechanical endpoint - difference in left ventricle global longitudinal strain between follow-up and baseline

Timeframe: 6 months

Trial details

NCT IDNCT07010029

SponsorMedical University of Warsaw

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05

Contact for this trial

Mariusz Tomaniak, Professor

+48 22 5991951 mariusz.tomaniak@wum.edu.pl

View on ClinicalTrials.gov More Angina With No Obstructive Coronary Artery Disease trials