The VIRTUE Post Marketing Surveillance Registry
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The VIRTUE Post Marketing Surveillance Registry - VALIANT Thoracic Stent Graft Evaluation For the Treatment of Descending Thoracic Aortic Dissections|
- Disease-, procedure- or device-related mortality at 12 months post-procedure [ Time Frame: 12 months post-procedure ] [ Designated as safety issue: No ]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.
- Health Economics [ Time Frame: Up to 6 months post-procedure ] [ Designated as safety issue: No ]Hospital and staff resources associated with the procedure and treatment up to six months post-procedure.
- Safety [ Time Frame: 30 days or at discharge, 3/6/12/24/36 months ] [ Designated as safety issue: Yes ]
- All causes mortality
- Disease-, procedure- or device-related mortality
- Efficacy/Performance [ Time Frame: 30 days or at discharge, 3/6/12/24/36 months ] [ Designated as safety issue: Yes ]
- Technical Success
- Freedom of re-intervention
- Freedom of disease-, stent- or procedure-related severe complications
- Freedom of disease-, stent- or procedure-related major complications
- Freedom of re-intervention and disease-, stent- or procedure-related severe complications
- Clinical Success
- Clinical Success and freedom of severe disease-, stent- or procedure-related complications
- Clinical Success and freedom of disease-, stent- or procedure-related major complications
|Study Start Date:||December 2006|
|Estimated Study Completion Date:||March 2013|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Descending thoracic aortic dissection
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.
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.
|Principal Investigator:||M. Thompson, Prof.||St George`s Hospital|
|Principal Investigator:||D. Gasparini, Dr.||Azienda Ospedaliera "Santa Maria della Misericordia"|
|Principal Investigator:||R. Fattori, Prof.||Ospedale Sant'Orsola Malpighi|
|Principal Investigator:||P. Cao, Dr.||Unità di Chirurgia Vascolare, Ospedale R. Silvestrini|
|Principal Investigator:||G. Garzón, Dr.||Hospital Universitario La Paz|
|Principal Investigator:||E. Ros, Prof.||Hospital Clínico Universitario San Cecilio|
|Principal Investigator:||B. Rylski, Dr.||Universitätsklinikum Freiburg|
|Principal Investigator:||S. Huptas, Dr.||Universitätsklinikum Essen|
|Principal Investigator:||I. Degrieck, Dr.||Onze-Lieve-Vrouw Ziekenhuis|
|Principal Investigator:||D. Dai-DoDo, Prof.||Universitätsspital Bern, Inselspital|
|Principal Investigator:||H. Roos, Dr.||Sahlgrenska University Hospital, Sweden|
|Principal Investigator:||R. Heijmen, Dr.||St. Antonius Ziekenhuis|
|Principal Investigator:||N. Cheshire, Prof.||St Mary's NHS Trust|
|Principal Investigator:||C. Nienaber, Dr||University School of Medicine Rostock|