N/A
N=100
The VIRTUE Post Marketing Surveillance Registry
Aortic Dissection
Bottom Line
View on ClinicalTrials.gov: NCT01213589 ↗Enrolled (actual)
100
Serious AEs
69.0%
Results posted
Dec 2013
Primary outcome: Primary: Disease-, Procedure- or Device-related Mortality at 12 Months Post-procedure — 9; 1; 1 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Endovascular
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease-, Procedure- or Device-related Mortality at 12 Months Post-procedure |
9; 1; 1 | — |
| SECONDARY Safety |
9; 1; 6 | — |
| SECONDARY Efficacy/Performance |
49; 24; 25 | — |
| SECONDARY Freedom of Re-intervention |
71.7; 68.8; 66.7 | — |
| SECONDARY Freedom From Disease-, Procedure- or Device-related Major Complications |
37.4; 41.3; 40.3 | — |
| SECONDARY Freedom From Disease-, Procedure-, or Device-related Severe Complications |
67.8; 75.0; 64.1 | — |
| SECONDARY Clinical Success |
18; 9; 8 | — |
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.
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).
Data sourced from ClinicalTrials.gov (NCT01213589). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.