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

Biosensors Europe SA101 enrolled

Overview

Biosensors, the Sponsor would like to determine if the Biosensors Microcatheter is safe and effective in treating patients with CTO by assessing a composite of in-hospital cardiac death or myocardial infarction and device success (defined as successfully facilitate placement of a guidewire beyond the occluded coronary segment), respectively.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

101

Conditions

Ischemic Heart Disease

Interventions

MicrocatheterDEVICE

Only to be used if Biosensor Microcatheter does not perform accordingly

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult aged \> 18 years 2. Patient understands and has signed the consent form. 3. 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. 4. Suitable candidate for non-emergent PCI 5. Left ventricle ejection fraction \> 25% Exclusion Criteria: 1. Patient unable to give informed consent. 2. Current participation in another study with any investigational drug or device. 3. Known or suspected contrast allergy. 4. in-stent CTO. 5. Planned treatment of a second CTO during the index procedure 6. Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel or Prasugrel or Ticagrelor). 7. Recent major cerebrovascular event (history of stroke or TIA within 1 month) 8. Renal insufficiency (serum creatinine of \> 200μmol/L) 9. Active gastrointestinal bleeding 10. Active infection or fever that may be due to infection 11. Life expectancy \< 2 years due to other illnesses 12. Significant anaemia (haemoglobin \< 10.0g/L) 13. Severe uncontrolled systemic hypertension (\> 240 mmHg within 1 month of procedure) 14. Severe electrolyte imbalance 15. Congestive heart failure \[New York Heart Association (NYHA) Class III\\IV\] CSA Class IV. 16. Unstable angina requiring emergent PCI or coronary artery bypass graft (CABG) 17. Recent myocardial infarction (MI) (within the past one week) 18. Unwillingness or inability to comply with any protocol requirements 19. 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. 20. Extensive prior dissection from a coronary guidewire use 21. Drug abuse or alcoholism. 22. Patients under custodial care. 23. Bleeding diathesis or coagulation disorder 24. Kawasaki's disease or other vasculitis

Locations (9)

Basildon and Thurrock University

Basildon, Essex, United Kingdom

Golden Jubilee Hospital,

Clydebank, Glasgow, Scotland, United Kingdom

St George's Hospital, Blackshaw Road,

London, Tooting, United Kingdom

Royal Victoria Hospital

Outcomes

Primary Outcomes

Efficacy: Percentage of patients with device success

Device success defined as successful placement of a guidewire in the vessel across the occluded coronary segment