Characterization of Aortic Tissue at Reoperation

Completed

• Conditions: Aortic Aneurysm; Aortic Dissection

• Registration Number: NCT02375542
• Lead Sponsor: CryoLife Europa

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.

Study Timeline

• Study First Submitted: 2014-08-19
• Study Start: 2015-02
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-03-02
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-18
• Last Update Posted: 2018-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

S.Orsola Malpighi Hospital; 🇮🇹 Bologna, Italy