NCT01915628

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
535

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

3.3 years

First QC Date

July 30, 2013

Last Update Submit

May 3, 2019

Conditions

Device Related MACE and Bleeding

Keywords

MACESafetyEfficacyOn labelMyocardial InfarctionCardiac deathTVRstent thrombosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Primary and secondary stent thrombosis

    30days, 6 months, 12 months and 2 years

  • Registry device oriented major adverse cardiac events (MACE) in the overall population

    30d, 6m and 2y

  • Individual MACE components

    30d, 6m, 12m and 2y

  • Bleeding per BARC criteria

    30d, 6m, 12m, 2y;

  • Patient Oriented Composite Endpoint

    30d, 6m, 12m, 2y

  • +3 more secondary outcomes

Other Outcomes (1)

  • Sub analyses

    through 2y

Study Arms (1)

BioMatrix Flex

percutaneous coronary intervention

Device: BioMatrix Flex

Interventions

BioMatrix FlexDEVICE

Percutaneous coronary intervention

BioMatrix Flex

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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%;
  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Victoria Heart Institute Foundation

Victoria, British Columbia, V8R 4R2, Canada

Location

Sunnybrook Health Sciences

Toronto, Ontario, M4N 3M5, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Conditions

HemorrhageMyocardial InfarctionDeath

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaNecrosis

Study Officials

  • Luc Bilodeau, MD

    Royal Victoria Hospital, Montreal, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2013

First Posted

August 5, 2013

Study Start

May 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2017

Last Updated

May 7, 2019

Record last verified: 2019-05

Locations

CA(4)