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| Name | Class |
|---|---|
| Royal Papworth Hospital | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liquid Biopsy System | Other | Main trial arm, all recruited and enrolled patients will undergo intracoronary blood sampling using the Liquid Biospy System Device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Correlations between primary outcome measure proteins and: patient subsets and lesion level data | Patient level subsets:
Lesion level data: - Coronary fibroatheroma cap thickness and lipid arc as measured by OCT image analysis | Single time point (time of intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events in subjects in whom the LBS is used | During intervention and subsequent 30 days | |
| Incidence of Major Adverse Cardiovascular Events | From enrolment to end of observation period at 4 years |
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:
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:
Stage 2 screening exclusion:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Contact | 01223638000 | papworth.biopattern@nhs.net | |
| PlaqueTec General Manager | Contact | simon@plaquetec.com |
| Name | Affiliation | Role |
|---|---|---|
| Steve Hoole | Royal Papworth Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Bournemouth Hospital | Recruiting | Bournemouth | United Kingdom |
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| Bristol Heart Institute | Recruiting | Bristol | United Kingdom |
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| Royal Papworth Hospital | Recruiting | Cambridge | United Kingdom |
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| Norfolk and Norwich Hospital | Recruiting | Norwich | United Kingdom |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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