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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Device: Microcatheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biosensors Microcatheter (BM)<br>Use of Biosensors Microcatheter | Device: Microcatheter<br>* Only to be used if Biosensor Microcatheter does not perform accordingly<br>* Other names: Standard hospital Microcatheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Percentage of patients with device success | Device success defined as successful placement of a guidewire in the vessel across the occluded coronary segment | Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first. | 
| Safety: Percentage of patients with composite of in-hospital cardiac death or myocardial infarction. | Composite of in-hospital cardiac death or myocardial infarction. | Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with technical success | Technical success is defined as achievement of TIMI grade 2 antegrade flow with less than 50% residual stenosis of the target CTO lesion at procedure end | Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first. | 
| Percentage of patients with procedural success | Procedural success defined as technical success plus the absence of in-hospital MACE (death, myocardial infarction or clinically-driven target vessel revascularization (cd TVR) | Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first. | 
| Percentage of patients with crossing success | Crossing success defined as the BM crossing the lesion | Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Total Occlusion (CTO), Microcatheter, CTO-PCI