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NCT02375542 Clinical Trial

Characterization of Aortic Tissue at Reoperation

Aortic Aneurysm Clinical Trial

Official title:
Clinical Observation and Pathological Characterization of Aortic Tissue at Reoperation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02375542
Other study ID # BIO1301.001M
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2015
Est. completion date January 2018

Study information
Verified date July 2018
Source CryoLife Europa
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date January 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy S.Orsola Malpighi Hospital Bologna

Sponsors (1)
Lead Sponsor Collaborator
CryoLife Europa

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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