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NCT Number: NCT06259019

Liquid Biopsy System Intracoronary Blood Sampling and Analysis to Characterise Disease Biomarkers in Patients With Coronary Disease

The aim of this research, proposed and funded by PlaqueTec and co-ordinated by Papworth Trials Unit Collaboration, is to demonstrate the performance of the coronary artery blood sampling device (Liquid Biospy System, LBS) and establish its usefulness to collect a range of disease biomolecules from the coronary artery of interest. Using the data generated from extensive analysis of the blood samples, key biomarker data will be generated that will close a knowledge gap and facilitate the development of tailored treatments for coronary artery disease.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Bournemouth Hospital, Bournemouth, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Stage 1 screening inclusion:

  • ≥18 years of age, have capacity and be willing to provide informed consent to participate
  • Clinical evidence of obstructive coronary artery disease and be scheduled for either:
  • Elective coronary angiography +/- proceed for stable angina OR
  • Elective PCI for stable angina with known bystander disease OR
  • 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:

  • Myocardial Infarction within 30 days of procedure.
  • Chronic renal failure (eGFR<30ml/min/1.73m2).
  • Contrast allergy.
  • Hypotension, shock or haemodynamic instability.
  • Ventricular arrhythmia.
  • Chronic Heart Failure (NYHA ≥ 3) or LVEF ≤ 30%.
  • Immunocompromised or receiving immunosuppressant therapy.
  • 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.
  • Active infection or sepsis (significant CRP elevation and/or requiring antibiotics).
  • Active systemic inflammatory condition.
  • Inability to receive anticoagulants or antiplatelets or uncorrected bleeding disorder or deranged platelet count.
  • Is pregnant.
  • Deemed high clinical risk or unsuitable for the procedure for any reason by the treating clinician.

Stage 2 screening exclusion:

  • Target lesion is in the left main coronary artery.
  • Unsuitable coronary anatomy (vessel tortuosity [>45 degree bend], moderate/ severe calcification angiographically, ostial disease).
  • Presence of thrombus in the target vessel.
  • Prior PCI or stent or graft in vessel identified for LBS sampling.
  • No clinical indication for either a PCI or a pressure wire assessment on any lesion.

Treatment and study plan

Liquid Biopsy System (LBS)

Device

Coronary artery catheter designed to mix intra-arterial flow and simultaneously extract multiple blood samples from around the site of coronary disease within a vessel of interest.

Other names: LBS

Primary outcomes

  1. Trans-plaque gradients (downstream value divided by upstream value) for LOX-1 and CXCL1

    Time frame: Single time point (time of intervention)

  2. Liquid Biopsy System (LBS) performance: successful positioning and successful intracoronary sampling

    Time frame: Single time point (time of intervention)

    Success define as confirmed adequate positioning of the device across the identified lesion of interest and collection of sufficient whole blood from each functional port to generate >100µl plasma once processed

Secondary outcomes

  1. Correlations between primary outcome measure proteins and: patient subsets and lesion level data

    Time frame: Single time point (time of intervention)

    Patient level subsets:

    • With and without type 2 diabetes mellitus
    • Prior/no prior history of Myocardial Infarction (MI)

    Lesion level data:

    • Coronary fibroatheroma cap thickness and lipid arc as measured by OCT image analysis

Other outcomes

  1. Incidence of adverse events in subjects in whom the LBS is used

    Time frame: During intervention and subsequent 30 days

  2. Incidence of Major Adverse Cardiovascular Events

    Time frame: From enrolment to end of observation period at 4 years

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Project Manager

CONTACT

[email protected]

01223638000

PlaqueTec General Manager

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

PlaqueTec Ltd

Industry

Collaborators

  • Royal Papworth Hospital

Registry information

Official study title

Site of Disease BIOmolecule Capture and Analysis in PATienTs With Established Coronary Disease undERgoing iNtracoronary Assessment

Acronym: BIOPATTERN

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Feb 14, 2024
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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