New mesh device aims to relieve chest pain when other treatments fail
NCT ID NCT07485985
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a small mesh device called a coronary sinus reducer in 25 people with severe chest pain from advanced coronary artery disease who cannot have stents or bypass surgery. The device is placed in a heart vein to increase pressure and improve blood flow. Researchers will measure changes in blood flow and chest pain episodes over 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 mesh device implanted in a heart vein)
- What this could lead to
- If it works, this could provide a new way to reduce chest pain and improve blood flow for people with advanced heart disease who cannot have standard treatments.
- What could go wrong
- This is a very small, early observational study with only 25 people, so results may not apply widely. The device is implanted and carries procedural 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 25 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 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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18 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: * 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. Exclusion Criteria: * 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. * 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.
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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 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.
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