e-BioMatrix Canada Registry

A Canadian Pre-market Registry of the BioMatrix Flex™ Drug Eluting Stents.

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.

Study Overview

• Status: Completed
• Conditions: Device Related MACE and Bleeding
• Intervention / Treatment: Device: BioMatrix Flex

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.

• Study Type: Observational
• Enrollment (Actual): 535

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Victoria, British Columbia, Canada, V8R 4R2
      • Victoria Heart Institute Foundation
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences
  • Quebec
    • Montreal, Quebec, Canada, H3A 1A1
      • Royal Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BioMatrix Flex; percutaneous coronary intervention	Device: BioMatrix Flex; Percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sub analyses	Small vessel disease; Diabetic patients; Acute coronary syndrome versus no acute coronary syndrome	through 2y

Collaborators and Investigators

• Sponsor: Biosensors Europe SA
• Investigators: Principal Investigator: Luc Bilodeau, MD, Royal Victoria Hospital, Montreal, Canada

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: July 30, 2013
• First Submitted That Met QC Criteria: August 2, 2013
• First Posted (Estimate): August 5, 2013

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 3, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Myocardial Infarction; stent thrombosis; MACE; TVR; On label; Cardiac death
• Other Study ID Numbers: 11-EU-02