Clinical Trials Logo
  1. Home
  2. Aortic Aneurysm
  3. NCT02375542
  4. Details
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
See also
  Status Clinical Trial Phase
Recruiting NCT04149600 - Identification of Genetic Causes of Calcific Aortic Valve Disease
Enrolling by invitation NCT04035356 - HAART Annuloplasty Device Valve Repair Registry
Recruiting NCT02729064 - Intraoperative Nasal Insulin Effect on Plasma and CSF Insulin Concentration and Blood Glucose Phase 1
Completed NCT02467062 - Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease. N/A
Completed NCT02283307 - Dual Energy CT Urography With Reduced Iodinated Contrast N/A
Completed NCT01678261 - X-chromosome Inactivation, Epigenetics and the Transcriptome N/A
Terminated NCT01055275 - Cook Iliac Branch Graft Post-market Registry N/A
Completed NCT00615888 - Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair N/A
Completed NCT03510793 - Microcirculation and Anesthesia in Vascular Surgery
Completed NCT03207568 - RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU) N/A
Recruiting NCT05073991 - Incidence of Mortality and Complications After Lung Surgery, Open Thoracic Aortic Repair, TEVAR, EVAR.
Completed NCT02000544 - Clinical Evaluation of a Modular Extracorporeal Circulation Circuit N/A
Not yet recruiting NCT01918982 - Circulating Endothelial Progenitor Cells and Aortic Aneurysm N/A
Not yet recruiting NCT01918969 - Reference Values of Circulating Endothelial Progenitor Cells N/A
Completed NCT01256372 - An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery Phase 2
Recruiting NCT00661518 - PET/CT Imaging of Aneurysm Wall Inflammation N/A
Completed NCT00094575 - Standard Open Surgery Versus Endovascular Repair of Abdominal Aortic Aneurysm (AAA) Phase 4
Recruiting NCT04471909 - NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness N/A
Recruiting NCT05603520 - Phenotyping Heterogeneity and Regionality of the Aorta
Completed NCT03727542 - Influence of Short AV Delay Permanent Pacing on Matrix Metalloproteinase Levels N/A