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OpenTrials
Completed

NCT Number: NCT02375542

Characterization of Aortic Tissue at Reoperation

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

Completed

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Key information

Conditions

Aortic Aneurysm Acute Aortic Syndrome Aneurysm Aortic Diseases Aortic Dissection Cardiovascular Diseases Dissection, Blood Vessel Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

S.Orsola Malpighi Hospital

Bologna, 40138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Observation and characterization of BioGlue usage during the reoperation procedure

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

Sponsors and collaborators

Lead sponsor

CryoLife Europa

Industry

Registry information

Official study title

Clinical Observation and Pathological Characterization of Aortic Tissue at Reoperation

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 2, 2015
Registry last updated
Jul 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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