New device captures heart artery clues for tailored therapies
NCT ID NCT06259019
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new device that collects blood samples directly from heart arteries in 300 people with coronary artery disease. Researchers will analyze these samples to find biomarkers that could help develop personalized treatments. The goal is to better understand the disease and improve future care.
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 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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: Stage 1 screening inclusion: 1. ≥18 years of age, have capacity and be willing to provide informed consent to participate 2. Clinical evidence of obstructive coronary artery disease and be scheduled for either: 1. Elective coronary angiography +/- proceed for stable angina OR 2. Elective PCI for stable angina with known bystander disease OR 3. Angiography +/- proceed for Troponin negative unstable angina Stage 2 screening inclusion: Suitable lesion identified meeting angiographic criteria for LBS deployment and Cardiologist comfortable to deploy OCT and LBS on study lesion before carrying out PCI on any lesion Exclusion Criteria: Stage 1 screening exclusion: 1. Myocardial Infarction within 30 days of procedure. 2. Chronic renal failure (eGFR\<30ml/min/1.73m2). 3. Contrast allergy. 4. Hypotension, shock or haemodynamic instability. 5. Ventricular arrhythmia. 6. Chronic Heart Failure (NYHA ≥ 3) or LVEF ≤ 30%. 7. Immunocompromised or receiving immunosuppressant therapy. 8. Any active disease that in the opinion of the investigator makes the subject unsuitable for the research procedure or subject life expectancy less than 1 year. 9. Active infection or sepsis (significant CRP elevation and/or requiring antibiotics). 10. Active systemic inflammatory condition. 11. Inability to receive anticoagulants or antiplatelets or uncorrected bleeding disorder or deranged platelet count. 12. Is pregnant. 13. Deemed high clinical risk or unsuitable for the procedure for any reason by the treating clinician. Stage 2 screening exclusion: 1. Target lesion is in the left main coronary artery. 2. Unsuitable coronary anatomy (vessel tortuosity \[\>45 degree bend\], moderate/ severe calcification angiographically, ostial disease). 3. Presence of thrombus in the target vessel. 4. Prior PCI or stent or graft in vessel identified for LBS sampling. 5. No clinical indication for either a PCI or a pressure wire assessment on any lesion.
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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
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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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Bristol Heart Institute
RECRUITINGBristol, United Kingdom
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Norfolk and Norwich Hospital
RECRUITINGNorwich, United Kingdom
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Royal Bournemouth Hospital
RECRUITINGBournemouth, United Kingdom
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Royal Papworth Hospital
RECRUITINGCambridge, United Kingdom
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Other studies related to the condition(s) this trial covers.
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