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Could a tiny mesh device ease stubborn chest pain?

NCT ID NCT06898541

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

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

40 years and older

Sex

Anyone

Healthy volunteers

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

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.

Angina Pectoris Angina, Stable coronary microvascular disorder intermediate coronary syndrome Microvascular Angina

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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

  • Maasstad Ziekenhuis

    Rotterdam, Netherlands

  • UMC Utrecht

    Utrecht, 3584CX, Netherlands

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