Characterization of Aortic Tissue at Reoperation

July 18, 2018 updated by: CryoLife Europa

Clinical Observation and Pathological Characterization of Aortic Tissue at Reoperation

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • S.Orsola Malpighi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Prospective, Single center, single arm study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cardiac Reoperation
Patients who have previously undergone a cardiac operation with the use of BioGlue and are now undergoing a reoperation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CryoLife Europa

Investigators

  • Principal Investigator: Davide Pacini, Dr, Cardiac surgeon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (ACTUAL)

January 1, 2018

Study Completion (ACTUAL)

January 1, 2018

Study Registration Dates

First Submitted

August 19, 2014

First Submitted That Met QC Criteria

February 24, 2015

First Posted (ESTIMATE)

March 2, 2015

Study Record Updates

Last Update Posted (ACTUAL)

July 19, 2018

Last Update Submitted That Met QC Criteria

July 18, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIO1301.001M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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