Characterization of Aortic Tissue at Reoperation | NCT02375542

Studies
Characterization of Aortic Tissue at Reoperation

NCT02375542

Sponsor

CryoLife Europa

Status

Completed

Last Update Posted

Jul 19, 2018Actual

Enrollment

11Actual

Phase

Not provided

Conditions

Aortic Aneurysm
Aortic Dissection

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Jan 2018Actual

Completion Date

Jan 2018Actual

First Submitted Date

Aug 19, 2014

First Submission Date that Met QC Criteria

Feb 24, 2015

First Posted Date

Mar 2, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2018

Last Update Posted Date

Jul 19, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cardiac Reoperation		Patients who have previously undergone a cardiac operation with the use of BioGlue and are now undergoing a reoperation

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Prospective, Single center, single arm study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Davide Pacini, Dr	Cardiac Surgeon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
S.Orsola Malpighi Hospital		Bologna		40138	Italy

Condition Browse Module

MeSH Terms

ID	Term
D001014	Aortic Aneurysm
D000784	Aortic Dissection

Ancestor Terms

ID	Term
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001018	Aortic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided