The VIRTUE Post Marketing Surveillance Registry - VALIANT Thoracic Stent Graft Evaluation For the Treatment of Descending Thoracic Aortic Dissections
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Dissection
- Sponsor
- Medtronic Endovascular
- Enrollment
- 100
- Primary Endpoint
- Disease-, Procedure- or Device-related Mortality at 12 Months Post-procedure
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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 with the Xcelerant Delivery System in the treatment of descending thoracic aortic dissections.
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 Xcelerant Delivery System is designed to treat diseases of the descending thoracic aorta including but not limited to aneurysms and dissections. The VALIANT Stent Graft is designed to exclude the aneurysm, the false lumen or site of rupture and restore the blood flow through the stent graft lumen. The device is intended for use either in patients who are candidates for conventional surgical repair, and in patients who are not candidates for conventional surgical repair due to pre-existing risk factors. This registry is a prospective, non-randomized, single-arm, multi-center, European clinical registry with patients diagnosed with descending thoracic aortic dissection. For this registry standard hospital procedures with respect to patient interventional care for thoracic aortic diseases will be followed. This is a descriptive registry in which no specific hypotheses will be statistically tested.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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).
Outcomes
Primary Outcomes
Disease-, Procedure- or Device-related Mortality at 12 Months Post-procedure
Time Frame: 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.
Secondary Outcomes
- 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)
- Clinical Success(through 36 months)