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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06259019
Other study ID # 65112021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 14, 2023
Est. completion date July 2025

Study information

Verified date February 2024
Source PlaqueTec Ltd
Contact Clinical Project Manager
Phone 01223638000
Email papworth.biopattern@nhs.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date July 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 not for PCI 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 other 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. Target lesion requires PCI 3. In same vessel as lesion requiring PCI 4. Unsuitable coronary anatomy (vessel tortuosity [>45 degree bend], moderate/ severe calcification angiographically, ostial disease). 5. Presence of thrombus in the target vessel. 6. Prior PCI or stent in vessel identified for LBS sampling

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Liquid Biopsy System (LBS)
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.

Locations

Country Name City State
United Kingdom Royal Bournemouth Hospital Bournemouth
United Kingdom Bristol Heart Institute Bristol
United Kingdom Royal Papworth Hospital Cambridge
United Kingdom Norfolk and Norwich Hospital Norwich

Sponsors (2)

Lead Sponsor Collaborator
PlaqueTec Ltd Royal Papworth Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Incidence of adverse events in subjects in whom the LBS is used During intervention and subsequent 30 days
Primary Trans-plaque gradients (downstream value divided by upstream value) for LOX-1 and CXCL1 Single time point (time of intervention)
Primary 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 Correlations between primary outcome measure proteins and: patient subsets and lesion level data 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
Single time point (time of intervention)
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