A Post Market Observational Study to Obtain Additional Information on the Use of Cormatrix® Cangaroo ECM® Envelope

Aziyo Biologics, Inc.39 sites in 1 country1,025 target enrollmentOctober 2015

ConditionsCardiovascular Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cardiovascular Disease
Sponsor: Aziyo Biologics, Inc.
Enrollment: 1025
Locations: 39
Primary Endpoint: Proportion of Subjects With ECM Related Adverse Events
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of the SECURE Study is to actively gather additional information on the use of the CorMatrix® CanGaroo ECM® Envelope in a post market observational study.

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

April 2018

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Aziyo Biologics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who have received CorMatrix® CanGaroo ECM® Envelope for an implantable electronic device placement.

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Proportion of Subjects With ECM Related Adverse Events

Time Frame: Participants were followed for an average of 235.0 days.

ECM related adverse events were collected at all study visits.

Number of Participants With Major Pocket Infections

Time Frame: Participants were followed for an average of 235.0 days.

Incidence of major pocket infection included those with cellulitis in the region of the CIED pocket with wound dehiscence, erosion or purulent drainage, 2) deep incisional or organ/space (pocket) surgical site infection, 3) persistent bacteremia or 4) endocarditis.