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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02681341
Other study ID # 015-236
Secondary ID
Status Completed
Phase N/A
First received January 22, 2016
Last updated October 24, 2017
Start date February 2016
Est. completion date September 21, 2017

Study information

Verified date October 2017
Source Baylor Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective of this study is to confirm that properties of CardioCel provide operative benefit to surgeons when compared to Dacron, CorMatrix, and all other bovine pericardium not treated with proprietary ADAPT engineering.


Description:

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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States The Heart Hospital Baylor Plano Plano Texas

Sponsors (2)

Lead Sponsor Collaborator
Baylor Research Institute Admedus Regen Pty Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 6 Month Duplex US Report to Measure Material Quality The 6 month duplex US report will measure peak velocity and flow through the repaired carotid artery, caliber, and occlusion/lesion status as per normal parameters used in post-CEA scans. Up to 6 months post CEA
Secondary OR Data and Surgeon Feedback During the Procedure The OR data from the procedure including blood loss and how long it took to achieve hemostasis in addition to surgeon feedback on bleeding, handling, and suturing of the material will be collected on a source worksheet. procedure
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