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

NCT06259019 | Active Not Recruiting DMC

• 1 other identifier: 65112021
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Liquid Biopsy System; Intracoronary; Biomarkers; PlaqueTec; BIOPATTERN

Outcome Measures

Primary Outcomes (2)

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

  Single time point (time of intervention)

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

  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

  Single time point (time of intervention)

Secondary Outcomes (1)

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

  Single time point (time of intervention)

Other Outcomes (1)

• Incidence of adverse events in subjects in whom the LBS is used

  During intervention and subsequent 30 days

Study Arms (1)

Liquid Biopsy System

OTHER

Main trial arm, all recruited and enrolled patients will undergo intracoronary blood sampling using the Liquid Biospy System Device.

Device: Liquid Biopsy System (LBS)

Interventions

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.

Also known as: LBS

Liquid Biopsy System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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 not for PCI OR
• Angiography +/- proceed for Troponin negative unstable angina
• 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 other lesion

You may not qualify if:

• 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.
• Target lesion is in the left main coronary artery.
• Target lesion requires PCI

Sponsors & Collaborators

• PlaqueTec Ltd: lead
• Royal Papworth Hospital: collaborator

Study Sites (4)

Royal Bournemouth Hospital

Bournemouth, United Kingdom

Location

Bristol Heart Institute

Bristol, United Kingdom

Location

Royal Papworth Hospital

Cambridge, United Kingdom

Location

Norfolk and Norwich Hospital

Norwich, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Steve Hoole

  Royal Papworth Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: February 14, 2024
• Study Start: September 14, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)