Characterization of Aortic Tissue at Reoperation

Clinical Observation and Pathological Characterization of Aortic Tissue at Reoperation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02375542

Enrollment

Registered

2015-03-02

Start date

2015-02-28

Completion date

2018-01-31

Last updated

2018-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Aneurysm, Aortic Dissection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The microscopic evaluation of the presence of BioGlue on aortic tissue	participants will be followed for the duration of their surgery, an expected average of 5 hours

Secondary

Measure	Time frame
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

Countries

Italy

Outcome results