Coronary Artery DiseaseBIOPATTERNNCT06259019
Liquid Biopsy System Intracoronary Blood Sampling and Analysis to Characterise Disease Biomarkers in Patients With Coronary Disease
A study testing Liquid Biopsy System (LBS) in people with Coronary Artery Disease, run by PlaqueTec Ltd at 4 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Liquid Biopsy System (LBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 14 Sep 2023to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
PlaqueTec General Manager contact
United Kingdom4 sites, 4 recruiting
- Recruiting
Royal Bournemouth Hospital
Bournemouth
Principal Investigator, peter.o'kane@uhd.nhs.uk
- Recruiting
Bristol Heart Institute
Bristol
Principal Investigator, tom.johnson@uhbw.nhs.uk
- Recruiting
Royal Papworth Hospital
Cambridge
Principal Investigator, steve.hoole@nhs.net
- Recruiting
Norfolk and Norwich Hospital
Norwich
Principal Investigator, alisdair.ryding@nnuh.nhs.uk
About this study
Official title: Site of Disease BIOmolecule Capture and Analysis in PATienTs With Established Coronary Disease undERgoing iNtracoronary Assessment
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
- Being tested
- Liquid Biopsy System (LBS)
- Keywords
- Liquid Biopsy System, Intracoronary, Biomarkers, PlaqueTec, BIOPATTERN
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid Biopsy System (LBS)Device
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Liquid Biopsy System | Other | Main trial arm, all recruited and enrolled patients will undergo intracoronary blood sampling using the Liquid Biospy System Device. Receives: Device: Liquid Biopsy System (LBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trans-plaque gradients (downstream value divided by upstream value) for LOX-1 and CXCL1
Measured: 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
Measured: Single time point (time of intervention)
Secondary outcomes (1)
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
Measured: Single time point (time of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start14 Sep 2023
- Primary completionDec 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PlaqueTec Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Royal Papworth Hospital
- Responsible party
- Sponsor
- Investigators
- Steve Hoole, Principal investigator, Papworth Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259019
- Sponsor's protocol ID
- 65112021
- Acronym
- BIOPATTERN
- Status last verified
- Mar 2026
- First submitted
- 12 Dec 2023
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Site of Disease BIOmolecule Capture and Analysis in PATienTs With Established Coronary Disease undERgoing iNtracoronary Assessment
- ClinicalTrials.gov ID
- NCT06259019
- Acronym / sponsor ID
- BIOPATTERN / 65112021
- Conditions
- Coronary Artery Disease
- Keywords
- Liquid Biopsy System, Intracoronary, Biomarkers, PlaqueTec, BIOPATTERN
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- PlaqueTec LtdIndustry (pharma, biotech, devices)
- Collaborators
- Royal Papworth Hospital
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liquid Biopsy System | Other | Device: Liquid Biopsy System (LBS)Main trial arm, all recruited and enrolled patients will undergo intracoronary blood sampling using the Liquid Biospy System Device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥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:
- 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
Key exclusion criteria (20 listed)
- Myocardial Infarction within 30 days of procedure.
- Chronic renal failure (eGFR<30ml/min/1.73m2).
- Contrast allergy.
- Hypotension, shock or haemodynamic instability.
- Ventricular arrhythmia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid Biopsy System (LBS)Also: LBSCoronary 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. | Device | Liquid Biopsy System |
Primary outcome
Trans-plaque gradients (downstream value divided by upstream value) for LOX-1 and CXCL1
Time frame: Single time point (time of intervention)
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
1 secondary outcome
Correlations between primary outcome measure proteins and: patient subsets and lesion level data
Time frame: Single time point (time of intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
PlaqueTec General Manager contact
Steve Hoole principal investigator
Papworth Hospital NHS Foundation Trust
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid Biopsy System (LBS) in people with Coronary Artery Disease, run by PlaqueTec Ltd at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Project Manager (01223638000, papworth.biopattern@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trans-plaque gradients (downstream value divided by upstream value) for LOX-1 and CXCL1 (time frame: Single time point (time of intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.