Coronary Sinus Reducer Therapy for Persisting Angina

NCT07485985 | Not Yet Recruiting FDA Device

• 1 other identifier: REDUCE ANGINA
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Coronary Artery Disease; Angina (Stable)

Keywords

Coronary Sinus Reducer; Refractory Angina; Coronary Artery Disease; Coronary Sinus Hemodynamics; Coronary Flow Reserve; Microvascular Resistance; Continuous Flow Thermodilution; Coronary Physiology

Outcome Measures

Primary Outcomes (2)

• Change in coronary flow reserve

  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

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

  Baseline and 6 months

Study Arms (1)

Experimental

EXPERIMENTAL

CSR arm

Device: Coronary sinus reducer

Interventions

Coronary sinus reducer DEVICE

Impantation of coronary sinus reducer

Also known as: reducer

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UMC Utrecht: lead
• University Medical Center Groningen: collaborator
• Maasstad Hospital: collaborator

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Stable; Angina Pectoris

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03