Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06259019

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

Led by PlaqueTec Ltd · Updated on 2026-04-03

300

Participants Needed

4

Research Sites

228 weeks

Total Duration

On this page

Sponsors

P

PlaqueTec Ltd

Lead Sponsor

R

Royal Papworth Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older and able to provide informed consent
  • Clinical evidence of obstructive coronary artery disease
  • Scheduled for elective coronary angiography with or without proceeding for stable angina
  • Scheduled for elective PCI for stable angina with known bystander disease
  • Scheduled for angiography with or without proceeding for troponin-negative unstable angina
  • Suitable lesion identified that meets angiographic criteria for LBS deployment
  • Cardiologist comfortable to deploy OCT and LBS on study lesion before PCI on any lesion
Not Eligible

You will not qualify if you...

  • Myocardial infarction within 30 days of procedure
  • Chronic renal failure with eGFR less than 30 ml/min/1.73m2
  • Allergy to contrast dye
  • Hypotension, shock, or hemodynamic instability
  • Ventricular arrhythmia
  • Chronic heart failure NYHA class 3 or higher or left ventricular ejection fraction 30% or less
  • Immunocompromised or receiving immunosuppressant therapy
  • Any active disease making the subject unsuitable or life expectancy less than 1 year
  • Active infection or sepsis requiring antibiotics or significant CRP elevation
  • Active systemic inflammatory condition
  • Inability to receive anticoagulants or antiplatelets or bleeding disorder
  • Pregnancy
  • High clinical risk or deemed unsuitable for the procedure by treating clinician
  • Target lesion in left main coronary artery
  • Unsuitable coronary anatomy including vessel tortuosity over 45 degrees, moderate/severe calcification, or ostial disease
  • Presence of thrombus in the target vessel
  • Prior PCI, stent, or graft in the vessel identified for LBS sampling
  • No clinical indication for PCI or pressure wire assessment on any lesion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Royal Bournemouth Hospital

Bournemouth, United Kingdom

Actively Recruiting

2

Bristol Heart Institute

Bristol, United Kingdom

Actively Recruiting

3

Royal Papworth Hospital

Cambridge, United Kingdom

Actively Recruiting

4

Norfolk and Norwich Hospital

Norwich, United Kingdom

Actively Recruiting

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Research Team

C

Clinical Project Manager

CONTACT

P

PlaqueTec General Manager

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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