A Prospective, Multi-Center, Non-randomized, Single Arm, Open Label, Study to Evaluate the Safety and Effectiveness of the Biosensors Microcatheter in Coronary Chronic Total Occlusions (CTO) - BIOMICS
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ischemic Heart Disease
- Sponsor
- Biosensors Europe SA
- Enrollment
- 101
- Locations
- 9
- Primary Endpoint
- Efficacy: Percentage of patients with device success
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Efficacy: Percentage of patients with device success
Time Frame: Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Device success defined as successful placement of a guidewire in the vessel across the occluded coronary segment
Safety: Percentage of patients with composite of in-hospital cardiac death or myocardial infarction.
Time Frame: Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Composite of in-hospital cardiac death or myocardial infarction.
Secondary Outcomes
- Percentage of patients with technical success(Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.)
- Percentage of patients with procedural success(Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.)
- Percentage of patients with crossing success(Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.)