Status:
COMPLETED
The VIRTUE Post Marketing Surveillance Registry
Lead Sponsor:
Medtronic Endovascular
Conditions:
Aortic Dissection
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed Description
The patient device for use in this registry is the Medtronic VALIANT Thoracic Stent Graft System that received CE mark approval in March 2005. The Medtronic VALIANT Thoracic Stent Graft with Xceleran...
Eligibility Criteria
Inclusion
- Patient will be more than or equal to 18 years of age; or older if required by local regulations.
- Patient has an indication for treatment by either endovascular stent graft implantation for either an acute, sub-acute or chronic Type B dissection.
- Patient is amenable for stent-graft treatment (in accordance with the IFU).
- The patient is willing and able to cooperate with registry procedures and required follow-up visits.
- The patient or legal guardian has signed a patient informed consent form, including data privacy authorization (this criteria is not applicable for patients presenting in emergency with ruptured dissection and for whom legal representative is not available informed consent can be requested after surgical procedure).
Exclusion
- Patients with a thoracic dissection for which optimal treatment is observation and medical management.
- Patient with current - non aortic - medical condition with a life expectancy less than one year.
- The patient is participating in another device or drug study (patient must have completed the follow-up phase of any previous study at least 30 days prior to enrolment in this registry).
- Time interval between medical indication for surgical intervention and endovascular procedure exceeds 4 months (122 days).
Key Trial Info
Start Date :
December 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01213589
Start Date
December 1 2006
End Date
October 1 2012
Last Update
December 11 2013
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