Clinical trial NCT01915628: e-BioMatrix Canada Registry
Official title: A Canadian Pre-market Registry of the BioMatrix Flex™ Drug Eluting Stents.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Device Related MACE and Bleeding
Keywords: MACE
Safety
Efficacy
On label
Myocardial Infarction
Cardiac death
TVR
stent thrombosis
Lead sponsor: Biosensors Europe SA
Sponsor class: INDUSTRY
First posted: 2013-08-05
Enrollment: 535
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients eligible for percutaneous coronary intervention with lesions suitable for stent implantation will be included according to the inclusion and exclusion criteria specified below.

Brief summary: 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.

Detailed description: The purpose of this registry is to capture additional "on-label" clinical data of the CE-marked BioMatrix Flex™ (BA9™-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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
2. Presence of coronary artery stenosis in one or two native coronary arteries from 2.25 to 4.0 mm in diameter that can be each covered with one BioMatrix FlexTM stent
3. Up to two lesions in two separate vessels to be treated

Exclusion Criteria:

1. Inability to provide informed consent;
2. Life expectancy less than 2 years;
3. Staged procedure planned within index procedure hospitalization;
4. ST elevation myocardial infarction;
5. Angiographic evidence of thrombus;
6. EF \< 20%;
7. Coronary artery bypass graft-lesion incl SVG;
8. Chronic total occlusion of the target lesion;
9. In stent restenosis
10. Bifurcation requiring 2 or more stents;
11. Left Main lesion;
12. Renal insufficiency (serum creatinine \> 260 µmolmol/L or \> 2.95mg/dl)
13. Multi-vessel disease with more than two vessels affected;
14. Have known intolerance to aspirin, clopidogrel, heparin, stainless steel, Biolimus A9 (limus compounds), contrast material;
15. Currently participating in another study;
16. Planning to have surgery within 6 months (excluding surgery which DAPT is maintained throughout the peri-surgical period);
17. Woman of childbearing potential with a positive pregnancy test.

Primary outcomes:
measure: Registry device-related MACE
timeFrame: 12 months
Secondary outcomes:
measure: Primary and secondary stent thrombosis
timeFrame: 30days, 6 months, 12 months and 2 years
measure: Registry device oriented major adverse cardiac events (MACE) in the overall population
timeFrame: 30d, 6m and 2y
measure: Individual MACE components
timeFrame: 30d, 6m, 12m and 2y
measure: Bleeding per BARC criteria
timeFrame: 30d, 6m, 12m, 2y;
measure: Patient Oriented Composite Endpoint
timeFrame: 30d, 6m, 12m, 2y
measure: Death and MI
timeFrame: 30d, 6m, 12m, 2y
measure: Death and post-procedural MI
timeFrame: 30d, 6m, 12m, 2y
measure: Antiplatelet compliance
timeFrame: 30d, 6m, 12m, 2y
Other outcomes:
measure: Sub analyses
timeFrame: through 2y
Locations:
city: Victoria
country: Canada
facility: Victoria Heart Institute Foundation
state: British Columbia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: Royal Victoria Hospital, Montreal, Canada
name: Luc Bilodeau, MD
role: PRINCIPAL_INVESTIGATOR
References: