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Prospective, multi-center registry to be conducted at 6 Canadian interventional cardiology centers. The e-BioMatrix data will be compared with a historical control group, the Cypher arm of the Biosensors Leaders study consisting of 313 patients. All patients will be followed for up to 2 years.
The purpose of this registry is to capture additional "on-label" clinical data of the CE-marked BioMatrix Flexâ„¢ (BA9â„¢-Eluting) stent system in relation to safety and effectiveness.
This prospective, multi-center registry will enroll a total of 533 patients. The BioMatrix FlexTM has been studied in randomized controlled trials and has been granted the CE mark. The data have been reviewed by Health Canada and no further randomized trials were requested. Prior to marketing approval, Health Canada requested that a registry be implemented to provide data in Canada on 'on label patients' to supplement the data already available from the Leaders trial, conducted on 'all comers' patients. The registry follows the normal medical practice for drug eluting stents in Canada. 100% informed consents will be checked, and at least all Major Adverse Cardiac Events up to 2 years will be source data verified. All MACEs developing in the patient population will be adjudicated by an independent Clinical Events Committee. The patients will be followed clinically for up to 2 years after stent implantation.
A third party Contract Research Organisation, Centre for Innovative Medicine has has been appointed to perform site monitoring and project management.
The appropriate Data Management and Validation, Statistical Analysis, Safety, Monitoring Plans and guidelines have been put into place to address quality and consistency of data.
A Clinical Event Committee (CEC) has been put in place for this registry, consisting of cardiologists not participating in the registry. The mandate of this CEC will be to review all Major Adverse Cardiac Events (MACE), to adjudicate and to classify them. In addition, and in order to protect study participants, there will be a regular review of all reported safety events by the sponsor Clinical Safety Officer and a weekly assessment of the incidence of the important risks pertaining to the registry in order to detect any safety signals.
The sites have been trained during the Site Initiation Visits on registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioMatrix Flex | percutaneous coronary intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioMatrix Flex | Device | Percutaneous coronary intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Registry device-related MACE | Registry device oriented major adverse cardiac events (MACE) plus bleeding events in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or justified target vessel revascularization at 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Primary and secondary stent thrombosis | definite and probable according to ARC definitions | 30days, 6 months, 12 months and 2 years |
| Registry device oriented major adverse cardiac events (MACE) in the overall population |
| Measure | Description | Time Frame |
|---|---|---|
| Sub analyses | Small vessel disease; Diabetic patients; Acute coronary syndrome versus no acute coronary syndrome | through 2y |
Inclusion Criteria:
Exclusion Criteria:
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Patients eligible for percutaneous coronary intervention with lesions suitable for stent implantation will be included according to the inclusion and exclusion criteria specified below.
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| Name | Affiliation | Role |
|---|---|---|
| Luc Bilodeau, MD | Royal Victoria Hospital, Montreal, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Victoria Heart Institute Foundation | Victoria | British Columbia | V8R 4R2 | Canada | ||
| Sunnybrook Health Sciences |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D009203 | Myocardial Infarction |
| D003643 | Death |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
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Defined as composite of cardiac death, myocardial infarction (Q- wave and non-Q-wave), or justified target vessel revascularization
| 30d, 6m and 2y |
| Individual MACE components | cardiac death, myocardial infarction, justified target vessel revascularization and bleeding events) | 30d, 6m, 12m and 2y |
| Bleeding per BARC criteria | BARC 3 to 5, all BARC, by vascular access site (femoral/radial) | 30d, 6m, 12m, 2y; |
| Patient Oriented Composite Endpoint | Defined as any cause mortality, MI (Q-wave and non-Q-wave), or any clinically driven target vessel revascularization; | 30d, 6m, 12m, 2y |
| Death and MI | 30d, 6m, 12m, 2y |
| Death and post-procedural MI | 30d, 6m, 12m, 2y |
| Antiplatelet compliance | 30d, 6m, 12m, 2y |
| Toronto |
| Ontario |
| M4N 3M5 |
| Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| Royal Victoria Hospital | Montreal | Quebec | H3A 1A1 | Canada |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |