Could a tiny mesh device ease stubborn chest pain?
NCT ID NCT06898541
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a device called a coronary sinus reducer in 50 people with chest pain caused by coronary microvascular disease, a condition where small heart vessels don't work properly. The device is implanted to narrow a heart vein, which may improve blood flow. Half the participants get the real device, half get a sham procedure, and researchers will compare changes in blood flow and daily chest pain episodes after 6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Coronary sinus reducer (a small mesh device implanted in a heart vein)
- What this could lead to
- If it works, this could provide a new treatment option for people with chest pain caused by small heart vessel disease who have few other choices.
- What could go wrong
- This is a small early-stage trial with only 50 participants, so results may not apply to everyone. The procedure involves implanting a device, which carries risks like infection or vessel damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria 1. 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. 2. Angina - Canadian Cardiovascular Society Class II-IV on at least two anti-anginals or maximally tolerated medical therapy if less than two. 3. Patient understands the nature of the procedure and provides written informed consent for the study prior to enrolment. Exclusion criteria 1. Age \< 18 years. 2. Absence of symptoms reported on the ORBITA-app during the 2-week screening period. 3. 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. 4. Prior positive acetylcholine provocation test with respect to epicardial vasospasm following the COVADIS criteria. 5. Mean right atrial pressure ≥15 mmHg 6. Severe pulmonary hypertension. 7. Coronary sinus anatomy not suitable for CSR implantation. 8. Pregnancy or planned pregnancy within the next 12 months. 9. Recent acute coronary syndrome (within 3 months). 10. Recent revascularization with PCI (within 6 months). 11. Severe arrhythmias, including chronic atrial fibrillation with persistent rapid ventricular response (\>100bpm despite medication). 12. Indication for cardiac resynchronization therapy. 13. Severe left ventricular impairment (left ventricular ejection fraction \<35%). 14. NYHA class IV or decompensated heart failure or hospitalization due to heart failure within 90 days before the index procedure. 15. Recent implantation of a permanent pacemaker or defibrillator lead in the right ventricle or atrium (within 90 days before the index procedure). 16. Presence of a pacemaker lead in the coronary sinus. 17. Severe valvular heart disease. 18. History of tricuspid valve replacement or repair. 19. Contra-indication to short term dual antiplatelet therapy or lifelong aspirin treatment. 20. 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. 21. Known inability to tolerate contrast medium. 22. Life expectancy \<1 year.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Maasstad Ziekenhuis
Rotterdam, Netherlands
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UMC Utrecht
Utrecht, 3584CX, Netherlands
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Other studies related to the condition(s) this trial covers.
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