Coronary Sinus Reducer Therapy for Persisting Angina

Refractory angina due to advanced obstructive coronary artery disease (CAD) remains a major clinical problem with limited evidence-based treatment options. The coronary sinus reducer (CSR) is an hourglass-shaped stainless-steel mesh device designed to create a controlled narrowing of the coronary sinus (CS). By increasing CS pressure, CSR implantation may improve myocardial perfusion and reduce anginal symptoms, although the physiological mechanisms underlying this effect remain incompletely understood.

REDUCE-ANGINA is a prospective observational study investigating the hemodynamic effects of CSR implantation in 25 patients with refractory angina and advanced CAD. The study evaluates the interaction between coronary sinus hemodynamics and coronary arterial blood flow before and after CSR implantation. The main study endpoints include changes in coronary sinus pressure, coronary flow reserve, microvascular resistance reserve, and absolute microvascular resistance from baseline to 6 months, measured using continuous flow thermodilution during saline-induced coronary hyperemia.

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Key information

Conditions

Coronary Artery Disease Angina (Stable) Angina Pectoris Angina, Stable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Angina - Canadian Cardiovascular Society Class II-IV on at least two anti-anginals or maximally tolerated medical therapy if less than two.Hemodynamically significant epicardial coronary artery disease in the LAD, defined as an FFR≤0.80 and/or NHPR≤0.89.
No conventional revascularization options or considered unsuitable as determined by the local heart team.
Anatomically suitable for instrumentation of the left anterior descending coronary artery with a coronary pressure wire and infusion microcatheter.
Patient understands the nature of the procedure and provides written informed consent for the study prior to enrolment.

Exclusion criteria

Age < 18 years.
Absence of symptoms reported on the ORBITA-app during the 2-week screening period.
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 <30%).
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.
Kidney failure (estimated glomerular filtration rate <30ml/min)
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.
Unable or unwilling to use the ORBITA app
Known inability to tolerate contrast medium.
Life expectancy <1 year.

Treatment and study plan

Coronary Sinus Reducer

Device

Impantation of coronary sinus reducer

Other names: reducer

Primary outcomes

Change in coronary flow reserve

Time frame: Baseline and 6 months

Change in coronary flow reserve from baseline to 6 months (measured by the continuous flow thermodilution technique using saline-induced coronary hyperaemia)
Angina episodes

Time frame: Baseline and 6 months

Difference in number of daily episodes of angina recorded on the ORBITA-app at 6 month follow-up.

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

Maasstad Hospital
University Medical Center Groningen

Registry information

Official study title

Impact of the Coronary Sinus Reducer on Invasive Hemodynamics and Angina in Patients With Advanced Coronary Artery Disease

Acronym: REDUCE ANGINA

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Mar 20, 2026
Registry last updated: Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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