Coronary Sinus Reducer Therapy for Persisting Angina (REDUCE ANGINA)

March 17, 2026 updated by: Tim P. van de Hoef, UMC Utrecht

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
CSR arm
Device: Coronary sinus reducer
Impantation of coronary sinus reducer
Other Names:
  • reducer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline and 6 months
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.
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Collaborators

University Medical Center Groningen
Maasstad Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REDUCE ANGINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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