Ischemic Heart Disease
Conditions
Keywords
Chronic Total Occlusion (CTO), Microcatheter, CTO-PCI
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.
Interventions
DEVICEMicrocatheter
Only to be used if Biosensor Microcatheter does not perform accordingly
Sponsors
Biosensors Europe SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Percentage of patients with device success | 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with crossing success | Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first. | Crossing success defined as the BM crossing the lesion |
| Percentage of patients with procedural success | Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first. | Procedural success defined as technical success plus the absence of in-hospital MACE (death, myocardial infarction or clinically-driven target vessel revascularization (cd TVR) |
| Percentage of patients with technical success | Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first. | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with device-related perforation | Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first. | Device-related perforation at the site of target coronary lesion and/or its proximal reference segment including donor artery or collateral |
| Percentage of patients with device failure | Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first. | Device failure is defined as: * any evidence of fracture of any part of the microcatheter, * evidence of wire puncture of any part of the device * and/or evidence of a fragment being retained in the body of the patient after a procedure. |
Countries
United Kingdom
Outcome results
None listed