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

Prior treatment

• Immunocompromised or receiving immunosuppressant therapy.
• Prior PCI or stent or graft in vessel identified for LBS sampling.

Other illness

• Myocardial Infarction within 30 days of procedure.
• Contrast allergy.
• Ventricular arrhythmia.
• 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.
• Unsuitable coronary anatomy (vessel tortuosity \[\>45 degree bend\], moderate/ severe calcification angiographically, ostial disease).

Lab values

• Chronic renal failure (eGFR\<30ml/min/1.73m2).
• Chronic Heart Failure (NYHA ≥ 3) or LVEF ≤ 30%.
• Inability to receive anticoagulants or antiplatelets or uncorrected bleeding disorder or deranged platelet count.

Other

• Stage 1 screening exclusion:
• Hypotension, shock or haemodynamic instability.
• 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.
• Presence of thrombus in the target vessel.
• No clinical indication for either a PCI or a pressure wire assessment on any lesion.

• 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