Coronary Artery DiseaseREDUCE ANGINANCT07485985
Coronary Sinus Reducer Therapy for Persisting Angina
A study testing Coronary sinus reducer in people with Coronary Artery Disease and Angina (Stable), run by UMC Utrecht.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Angina (Stable)
- What is being tested?
- Coronary sinus reducer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease, Angina (Stable)
- Being tested
- Coronary sinus reducer
- Keywords
- Coronary Sinus Reducer, Refractory Angina, Coronary Artery Disease, Coronary Sinus Hemodynamics, Coronary Flow Reserve, Microvascular Resistance, Continuous Flow Thermodilution, Coronary Physiology
- Medical subject headings
- Coronary Artery Disease, Angina, Stable, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary sinus reducerDevice
Also called reducer
Impantation of coronary sinus reducer
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | CSR arm Receives: Device: Coronary sinus reducer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and 6 months
Angina episodes
Difference in number of daily episodes of angina recorded on the ORBITA-app at 6 month follow-up.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen, Maasstad Hospital
- Responsible party
- Principal investigator, Tim P. van de Hoef, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485985
- Sponsor's protocol ID
- REDUCE ANGINA
- Acronym
- REDUCE ANGINA
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Coronary Sinus Reducer on Invasive Hemodynamics and Angina in Patients With Advanced Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT07485985
- Acronym / sponsor ID
- REDUCE ANGINA / REDUCE ANGINA
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- University Medical Center Groningen, Maasstad Hospital
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Coronary sinus reducerCSR arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary sinus reducerAlso: reducerImpantation of coronary sinus reducer | Device | Experimental |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary sinus reducer in people with Coronary Artery Disease and Angina (Stable), run by UMC Utrecht.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in coronary flow reserve (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.