NCT01213589|CompletedResultsDMC
The VIRTUE Post Marketing Surveillance Registry
VIRTUE
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Sponsor study identifier
observational
100
0 countries
N/A
Study Start
December 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
Actual (reported)The purpose of this post-market release registry is to collect additional information concerning safety, performance and health economic data with respect to the Medtronic VALIANT Thoracic Stent Graft with the Xcelerant Delivery System in the treatment of descending thoracic aortic dissections.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2006
Date type not reportedThis date has not been verified as actual or estimated.
October 1, 2010
Actual (reported)October 4, 2010
Actual (reported)October 2012
Actual (reported)October 2012
Actual (reported)December 11, 2013
Actual (reported)Disease-, Procedure- or Device-related Mortality at 12 Months Post-procedure
Disease, device or procedure-related mortality at 12 months post-procedure, defined as any death related to the device, to the disease or to the surgical procedure occurring in the period of 365 days following the day of the implant procedure.
12 months post-procedure
Safety
30 days or at discharge, 3/6/12/24/36 months
Efficacy/Performance
30 days or at discharge, 3/6/12/24/36 months
Freedom of Re-intervention
30 days or at discharge, 3/6/12/24/36 months
Freedom From Disease-, Procedure- or Device-related Major Complications
through 36 months
Freedom From Disease-, Procedure-, or Device-related Severe Complications
through 36 months
Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for either an acute, sub-acute or chronic Type B dissection.
Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation will be enrolled in the registry.
Virtue Registry Investigators. The VIRTUE Registry of type B thoracic dissections--study design and early results. Eur J Vasc Endovasc Surg. 2011 Feb;41(2):159-66. doi: 10.1016/j.ejvs.2010.08.016. Epub 2010 Oct 16.
M. Thompson, Prof.
St George's Hospital
D. Gasparini, Dr.
Azienda Ospedaliera "Santa Maria della Misericordia"
R. Fattori, Prof.
Ospedale Sant'Orsola Malpighi
P. Cao, Dr.
Unità di Chirurgia Vascolare, Ospedale R. Silvestrini
100 participants (actual enrollment reported by the registry).
First Submitted
October 1, 2010
First Posted
October 4, 2010
Study Start
December 2006
Date type not reportedThis date has not been verified as actual or estimated.
Safety and Efficacy Study Of The Thoracic Aortic Stent Graft System Treating Aortic Dissection
Logistic Regression of Risk Factor for the 5-year Mortality of Aortic Dissection
Contact the study team to confirm eligibility.
G. Garzón, Dr.
Hospital Universitario La Paz
E. Ros, Prof.
Hospital Clínico Universitario San Cecilio
B. Rylski, Dr.
University Hospital Freiburg
S. Huptas, Dr.
Universitätsklinikum Essen
I. Degrieck, Dr.
Onze-Lieve-Vrouw Ziekenhuis
D. Dai-DoDo, Prof.
Universitätsspital Bern, Inselspital
H. Roos, Dr.
Sahlgrenska University Hospital
R. Heijmen, Dr.
St. Antonius Hospital
N. Cheshire, Prof.
St Mary's NHS Trust
C. Nienaber, Dr
University School of Medicine Rostock
Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
Actual (reported)Last Updated
December 11, 2013
Results First Posted
December 11, 2013
Record last verified: 2013-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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