Study to Evaluate the Safety and Effectiveness of the Biosensors Microcatheter in Coronary Chronic Total Occlusions (CTO) - BIOMICS

Prospective, multi-center, open-label single-arm trial designed to enroll 100 patients undergoing attempted CTO-PCI at up to 10 centers in the United Kingdom and N. Ireland. For assessment of efficacy, the ability of the BM to successfully facilitate placement of a guidewire beyond the occluded coronary segment will be assessed. Patients will be followed up until hospital discharge or 7 days post index procedure, whichever comes first. For the assessment of safety, the incidence of in-hospital cardiac death or myocardial infarction will be assessed at hospital discharge or 7 days post index procedure, whichever comes first.

Inclusion criteria

• Adult aged > 18 years
• Patient understands and has signed the consent form.
• Patient has an angiographically documented chronic total occlusion (i.e. estimated to be >3 months duration) showing distal TIMI 0 flow. Occlusion with absence of antegrade flow through the lesion and with a presumed or documented duration of 3 months.
• Suitable candidate for non-emergent PCI
• Left ventricle ejection fraction > 25%

Exclusion criteria

• Patient unable to give informed consent.
• Current participation in another study with any investigational drug or device.
• Known or suspected contrast allergy.
• in-stent CTO.
• Planned treatment of a second CTO during the index procedure
• Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel or Prasugrel or Ticagrelor).
• Recent major cerebrovascular event (history of stroke or TIA within 1 month)
• Renal insufficiency (serum creatinine of > 200μmol/L)
• Active gastrointestinal bleeding
• Active infection or fever that may be due to infection
• Life expectancy < 2 years due to other illnesses
• Significant anaemia (haemoglobin < 10.0g/L)
• Severe uncontrolled systemic hypertension (> 240 mmHg within 1 month of procedure)
• Severe electrolyte imbalance
• Congestive heart failure [New York Heart Association (NYHA) Class III\\IV] CSA Class IV.
• Unstable angina requiring emergent PCI or coronary artery bypass graft (CABG)
• Recent myocardial infarction (MI) (within the past one week)
• Unwillingness or inability to comply with any protocol requirements
• Subject is pregnant or nursing. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
• Extensive prior dissection from a coronary guidewire use
• Drug abuse or alcoholism.
• Patients under custodial care.
• Bleeding diathesis or coagulation disorder
• Kawasaki's disease or other vasculitis