Angina (Stable)REDUCE CMDNCT06898541
Coronary Sinus Reducer in Coronary Microvascular Disease
A study testing Coronary sinus reducer in people with Angina (Stable) and Coronary Microvascular Disease, run by UMC Utrecht at 2 sites in Netherlands.
Trial summary
Coronary microvascular dysfunction (CMD) is a common cause of treatment- resistant angina that lacks evidence-based treatment options. The coronary sinus reducer (CSR) is an hourglass-shaped stainless steel mesh, designed to create a controlled narrowing of the coronary sinus (CS). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Angina (Stable), Coronary Microvascular Disease
- What is being tested?
- Coronary sinus reducer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesNetherlands
- Study dates
- 20 Nov 2025to 1 Nov 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary microvascular dysfunction in the left anterior descending coronary artery (LAD) as expressed by abnormal absolute coronary flow reserve (CFR<2.5) confirmed during the index study procedure using the continuous thermodilution technique and saline-induced coronary hyperaemia.
- Angina - Canadian Cardiovascular Society Class II-IV on at least two anti-anginals or maximally tolerated medical therapy if less than two.
- 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.
- Presence of hemodynamically significant epicardial stenoses based on both non- hyperaemic pressure ratio (NHPR; iFR≤0.89, or RFR≤0.89, or dFR/dPR≤0.89) or fractional flow reserve (FFR≤0.80) assessments.
- Prior positive acetylcholine provocation test with respect to epicardial vasospasm following the COVADIS criteria.
- Mean right atrial pressure ≥15 mmHg
- Severe pulmonary hypertension.
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- 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 <35%).
- 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.
- 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.
- Known inability to tolerate contrast medium.
- Life expectancy <1 year.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites
Maasstad Ziekenhuis
Rotterdam
UMC Utrecht
Utrecht, 3584CX
About this study
Official title: Impact of the Coronary Sinus Reducer on Coronary Flow Reserve and Symptoms in Patients With Coronary Microvascular Disease
Coronary microvascular dysfunction (CMD) is a common cause of treatment- resistant angina that lacks evidence-based treatment options. The coronary sinus reducer (CSR) is an hourglass-shaped stainless steel mesh, designed to create a controlled narrowing of the coronary sinus (CS). By augmenting CS pressure, CSR implantation was shown to improve myocardial perfusion, potentially providing a novel treatment for patients with CMD. REDUCE CMD is a placebo-controlled study of CSR in 50 patients with CMD. The main study endpoints are the change in coronary flow reserve from baseline to 6 months in the CSR-arm versus the placebo arm, and the difference in number of daily episodes of angina recorded on the ORBITA-app at 6 month follow-up in the CSR-arm versus the placebo arm.
- Conditions
- Angina (Stable), Coronary Microvascular Disease
- Being tested
- Coronary sinus reducer, Sham CSR procedure
- Keywords
- Angina, Coronary microvascular disease, Coronary sinus reducer
- Medical subject headings
- Angina, Stable, Microvascular Angina, 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
Implantation of a Coronary Sinus Reducer device
Sham CSR procedureOther
Also called Sham
Patients will undergo a complete sham CSR implantation procedure without actual deployment of the CSR.
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | Patients in this arm undergo a sham CSR procedure. Receives: Other: Sham CSR procedure |
| CSR arm | Experimental | Patients in this arm undergo coronary sinus reducer implantation. 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 in the CSR-arm versus the placebo arm (measured by the continuous flow thermodilution technique using saline-induced coronary hyperaemia).
Measured: 6 months
Angina episodes
Difference in number of daily episodes of angina recorded on the ORBITA-app at 6 month follow-up in the CSR-arm versus the placebo arm.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start20 Nov 2025
- Primary completion1 May 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina (Stable)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center, Maasstad Hospital, Rotterdam, VieCuri, Venlo, the Netherlands
- Responsible party
- Principal investigator, Tim P. van de Hoef, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898541
- Sponsor's protocol ID
- REDUCE CMD
- Acronym
- REDUCE CMD
- Status last verified
- Nov 2025
- First submitted
- 4 Jan 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Coronary Sinus Reducer on Coronary Flow Reserve and Symptoms in Patients With Coronary Microvascular Disease
- ClinicalTrials.gov ID
- NCT06898541
- Acronym / sponsor ID
- REDUCE CMD / REDUCE CMD
- Conditions
- Angina (Stable), Coronary Microvascular Disease
- Keywords
- Angina, Coronary microvascular disease, Coronary sinus reducer
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Radboud University Medical Center, Maasstad Hospital, Rotterdam, VieCuri, Venlo, the Netherlands
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 27 Mar 2025 (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.
Coronary microvascular dysfunction (CMD) is a common cause of treatment- resistant angina that lacks evidence-based treatment options. The coronary sinus reducer (CSR) is an hourglass-shaped stainless steel mesh, designed to create a controlled narrowing of the coronary sinus (CS). By augmenting CS pressure, CSR implantation was shown to improve myocardial perfusion, potentially providing a novel treatment for patients with CMD. REDUCE CMD is a placebo-controlled study of CSR in 50 patients with CMD. The main study endpoints are the change in coronary flow reserve from baseline to 6 months in the CSR-arm versus the placebo arm, and the difference in number of daily episodes of angina recorded on the ORBITA-app at 6 month follow-up in the CSR-arm versus the placebo arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Other: Sham CSR procedurePatients in this arm undergo a sham CSR procedure. |
| CSR arm | Experimental | Device: Coronary sinus reducerPatients in this arm undergo coronary sinus reducer implantation. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Coronary microvascular dysfunction in the left anterior descending coronary artery (LAD) as expressed by abnormal absolute coronary flow reserve (CFR<2.5) confirmed during the index study procedure using the continuous thermodilution technique and saline-induced coronary hyperaemia.
- Angina - Canadian Cardiovascular Society Class II-IV on at least two anti-anginals or maximally tolerated medical therapy if less than two.
- 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.
- Presence of hemodynamically significant epicardial stenoses based on both non- hyperaemic pressure ratio (NHPR; iFR≤0.89, or RFR≤0.89, or dFR/dPR≤0.89) or fractional flow reserve (FFR≤0.80) assessments.
- Prior positive acetylcholine provocation test with respect to epicardial vasospasm following the COVADIS criteria.
- Mean right atrial pressure ≥15 mmHg
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: reducerImplantation of a Coronary Sinus Reducer device | Device | CSR arm |
| Sham CSR procedureAlso: ShamPatients will undergo a complete sham CSR implantation procedure without actual deployment of the CSR. | Other | Sham |
Primary outcome
Change in coronary flow reserve
Time frame: 6 months
Change in coronary flow reserve from baseline to 6 months in the CSR-arm versus the placebo arm (measured by the continuous flow thermodilution technique using saline-induced coronary hyperaemia).
Angina episodes
Time frame: 6 months
Difference in number of daily episodes of angina recorded on the ORBITA-app at 6 month follow-up in the CSR-arm versus the placebo arm.
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 4 Dec 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary sinus reducer in people with Angina (Stable) and Coronary Microvascular Disease, run by UMC Utrecht at 2 sites in Netherlands.
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 3 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: enrolling by invitation, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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: 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 4 Dec 2025.