Device Related MACE and BleedingNCT01915628
e-BioMatrix Canada Registry
An observational study of Device Related MACE and Bleeding, run by Biosensors Europe SA at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Device Related MACE and Bleeding
- What is being tested?
- BioMatrix Flex
- Type of treatment
- Medical device
- How many people
- 535 participants
- Where
- 4 sitesCanada
- Study dates
- May 2013to Sep 2017
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥18 years
- 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
- Up to two lesions in two separate vessels to be treated
Who cannot join
- Inability to provide informed consent;
- Life expectancy less than 2 years;
- Staged procedure planned within index procedure hospitalization;
- ST elevation myocardial infarction;
- Angiographic evidence of thrombus;
- EF < 20%;
Show all 17Show fewer
- Coronary artery bypass graft-lesion incl SVG;
- Chronic total occlusion of the target lesion;
- In stent restenosis
- Bifurcation requiring 2 or more stents;
- Left Main lesion;
- Renal insufficiency (serum creatinine > 260 µmolmol/L or > 2.95mg/dl)
- Multi-vessel disease with more than two vessels affected;
- Have known intolerance to aspirin, clopidogrel, heparin, stainless steel, Biolimus A9 (limus compounds), contrast material;
- Currently participating in another study;
- Planning to have surgery within 6 months (excluding surgery which DAPT is maintained throughout the peri-surgical period);
- Woman of childbearing potential with a positive pregnancy test.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
Sunnybrook Health Sciences
Toronto, Ontario, M4N 3M5
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Victoria Heart Institute Foundation
Victoria, British Columbia, V8R 4R2
About this study
Official title: 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.
Read the 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.
- Conditions
- Device Related MACE and Bleeding
- Being tested
- BioMatrix Flex
- Keywords
- MACE, Safety, Efficacy, On label, Myocardial Infarction, Cardiac death, TVR, stent thrombosis
- Medical subject headings
- Hemorrhage, Myocardial Infarction, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioMatrix FlexDevice
Percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| BioMatrix Flex | percutaneous coronary intervention Receives: Device: BioMatrix Flex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (8)
Primary and secondary stent thrombosis
definite and probable according to ARC definitions
Measured: 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
Measured: 30d, 6m and 2y
Individual MACE components
cardiac death, myocardial infarction, justified target vessel revascularization and bleeding events)
Measured: 30d, 6m, 12m and 2y
Bleeding per BARC criteria
BARC 3 to 5, all BARC, by vascular access site (femoral/radial)
Measured: 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;
Measured: 30d, 6m, 12m, 2y
Death and MI
Measured: 30d, 6m, 12m, 2y
Death and post-procedural MI
Measured: 30d, 6m, 12m, 2y
Antiplatelet compliance
Measured: 30d, 6m, 12m, 2y
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Device Related MACE and BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 535 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Biosensors Europe SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luc Bilodeau, MD, Principal investigator, Royal Victoria Hospital, Montreal, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915628
- Sponsor's protocol ID
- 11-EU-02
- Status last verified
- May 2019
- First submitted
- 30 Jul 2013
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Canadian Pre-market Registry of the BioMatrix Flex™ Drug Eluting Stents.
- ClinicalTrials.gov ID
- NCT01915628
- Acronym / sponsor ID
- 11-EU-02
- Conditions
- Device Related MACE and Bleeding
- Keywords
- MACE, Safety, Efficacy, On label, Myocardial Infarction, Cardiac death, TVR, stent thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- Biosensors Europe SAIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioMatrix Flex | – | Device: BioMatrix Flexpercutaneous coronary intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥18 years
- 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
- Up to two lesions in two separate vessels to be treated
Key exclusion criteria (17 listed)
- Inability to provide informed consent;
- Life expectancy less than 2 years;
- Staged procedure planned within index procedure hospitalization;
- ST elevation myocardial infarction;
- Angiographic evidence of thrombus;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioMatrix FlexPercutaneous coronary intervention | Device | BioMatrix Flex |
Primary outcome
Registry device-related MACE
Time frame: 12 months
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.
8 secondary outcomes
Primary and secondary stent thrombosis
Time frame: 30days, 6 months, 12 months and 2 years
Registry device oriented major adverse cardiac events (MACE) in the overall population
Time frame: 30d, 6m and 2y
Individual MACE components
Time frame: 30d, 6m, 12m and 2y
Bleeding per BARC criteria
Time frame: 30d, 6m, 12m, 2y;
Patient Oriented Composite Endpoint
Time frame: 30d, 6m, 12m, 2y
Death and MI
Time frame: 30d, 6m, 12m, 2y
Death and post-procedural MI
Time frame: 30d, 6m, 12m, 2y
Antiplatelet compliance
Time frame: 30d, 6m, 12m, 2y
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc Bilodeau, MD principal investigator
Royal Victoria Hospital, Montreal, Canada
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Device Related MACE and Bleeding, run by Biosensors Europe SA at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Registry device-related MACE (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019.