Clinical Observation and Pathological Characterization of Aortic Tissue at Reoperation

CryoLife Europa1 site in 1 country11 target enrollmentFebruary 2015

ConditionsAortic Aneurysm Aortic Dissection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Aneurysm
Sponsor: CryoLife Europa
Enrollment: 11
Locations: 1
Primary Endpoint: The microscopic evaluation of the presence of BioGlue on aortic tissue
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will analyse factors contributing to cardiac re-operation to determine causative effects

Detailed Description

This study will collect clinical data on the characteristics of aortic tissue on which BioGlue has been applied during a previous cardiovascular surgery. This is a post market surveillance study.

Registry

clinicaltrials.gov

Start Date

February 2015

End Date

January 2018

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

CryoLife Europa

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects undergoing an aortic re-operation
•Subject has had BioGlue used during previous aortic surgery
•Subject is willing and able to give written informed consent for participation

Exclusion Criteria

•Subject with a history of vasculitis
•Subject with active infection (endocarditis)
•Subject with a history of chronic inflammatory condition which may have led to ongoing tissue damage
•Subject with a history of auto immune disease

Outcomes

Primary Outcomes

The microscopic evaluation of the presence of BioGlue on aortic tissue

Time Frame: "participants will be followed for the duration of their surgery, an expected average of 5 hours

Secondary Outcomes

Observation and characterization of BioGlue usage during the reoperation procedure("participants will be followed for the duration of their surgery, an expected average of 5 hours)