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Can an Hourglass-Shaped device relieve chest pain when arteries Aren't blocked?

NCT ID NCT05492110

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This pilot trial is testing whether a device called the Coronary Sinus Reducer can help people with angina (chest pain) who have no significant blockages in their coronary arteries. The device, shaped like an hourglass, is placed into a vein in the heart to improve blood flow. The study will compare the device to a sham procedure and measure changes in heart blood flow and symptoms over six 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 device
What this could lead to
If effective, this device could offer a new treatment option for people with angina who have no blocked arteries, improving their symptoms and quality of life.
What could go wrong
This is a small pilot study, so results may not be definitive. The procedure is invasive and carries risks, and the device may not improve symptoms for everyone.

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

54 people

The number who actually took part.

Started

Apr 2023

Expected to finish

Aug 2026

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

18 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. Age \>18 years 2. Ongoing symptomatic angina, CCS Class II-IV, for ≥3 months despite background treatment with at least two anti-anginal drugs at the maximal tolerated dose. 3. Patients willing to consider no change in anti-anginal drug treatment for the duration of their participation in the trial. 4. Unobstructed coronary arteries with ≤50% epicardial stenoses demonstrated on coronary angiography. 5. Stress-induced hypoperfusion on CMR (Global MPR ≤ 2.2). 6. Willingness to comply with the specified follow-up evaluation and to be contactable during the period of the trial. 7. Understands the nature of the trial procedures and provides written informed consent. Exclusion Criteria: 1. Epicardial CAD in a main coronary artery (stenoses \>50%, RFR≤0.92 or FFR≤0.80), percutaneous coronary intervention (PCI; within previous 6 months, stent insertion for acute Type 1 MI or chronic total occlusion (CTO)), coronary artery bypass grafting, or confirmed Type 1 myocardial infarction (MI). 2. Abnormal coronary sinus anatomy (tortuosity, aberrant branch, persistent left superior vena cava) 3. Coronary sinus diameter unsuitable for device implantation at operator discretion 4. Mean right atrial pressure \>15mmHg at time of implantation 5. Structural heart disease including left ventricular hypertrophy with raised LV mass index; cardiomyopathy; severe valvular heart disease; previous valve replacement; significant myocardial bridge on angiography; LVEF\<45% by CMR. 6. Clinically or angiographically diagnosed coronary vasospasm 7. Previous hospitalisation for decompensated heart failure 8. Pacemaker or defibrillator electrode in the right atrium, right ventricle or coronary sinus 9. Documented arrhythmia requiring planned implantation of a permanent pacemaker or defibrillator 10. Chronic kidney disease (creatinine \>200 micromol/L; established on renal replacement therapy; functioning renal transplant) 11. Haemoglobin \<80g/L 12. Contraindications to receiving dual antiplatelet therapy 13. Severe chronic obstructive pulmonary disease (FEV1 \<55% predicted) 14. Moribund patients with life expectancy \< 1year 15. Known allergy to nickel or steel 16. Current enrolment in another investigational device or drug trial 17. Contraindications to CMR or receiving intravenous adenosine 18. Pregnancy

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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.

Contacts and locations

Locations

  • National Heart and Lung Institute (Brompton Campus), Imperial College London

    London, London, SW36NP, United Kingdom

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Other studies related to the condition(s) this trial covers.