The VIRTUE Post Marketing Surveillance Registry (VIRTUE)
|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 ]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.
- Safety [ Time Frame: 30 days or at discharge, 3/6/12/24/36 months ]
- All causes mortality
- Disease-, procedure- or device-related mortality
- Efficacy/Performance [ Time Frame: 30 days or at discharge, 3/6/12/24/36 months ]- Technical Success Technical success, defined as a composite of (i) successful introduction and deployment of at least one Valiant Thoracic Stent Graft at the intended location, (ii) successful coverage of the proximal entry tear, (iii) no immediate conversion to open surgery during the same intervention, (iv) absence of death within 24 hours post-procedure, and (v) the absence of significant graft twist, kink or obstruction by intra-operative measurements
- Freedom of Re-intervention [ Time Frame: 30 days or at discharge, 3/6/12/24/36 months ]Kaplan-Meier estimate of freedom from secondary procedures by clinical group.
- Freedom From Disease-, Procedure- or Device-related Major Complications [ Time Frame: through 36 months ]
Complications were assigned a severity score (according SVS scores) so that degrees of morbidity can be assessed and compared. A moderate complication indicates the need for significant intervention, prolongation of hospitalization more than 24 hours, and at most, minor permanent disability that does not preclude normal daily activity. A severe complication necessitates major surgical or medical intervention, may be associated with prolonged convalescence, is usually accompanied by prolonged or permanent disability, and may result in death. Both moderate and severe complications are considered as major complications.
Kaplan-Meier estimate of freedom from disease-, procedure-, or device-related major complications by clinical group.
- Freedom From Disease-, Procedure-, or Device-related Severe Complications [ Time Frame: through 36 months ]
Complications were assigned a severity score (according SVS scores) so that degrees of morbidity can be assessed and compared. A severe complication necessitates major surgical or medical intervention, may be associated with prolonged convalescence, is usually accompanied by prolonged or permanent disability, and may result in death.
Kaplan-Meier estimate of freedom from disease-, procedure-, or device-related severe complications
- Clinical Success [ Time Frame: through 36 months ]
Clinical success was defined as: (i) successful introduction and deployment of the Valiant Thoracic Stent Graft at the intended location; (ii) successful coverage of the proximal entry tear; (iii) no immediate conversion to open surgery;(iv) absence of surgical open repair or endovascular re-intervention; (v) absence of death related to aortic disease or treatment; (vi) absence of graft thrombosis, obstructions, twists or kinks; (vii) absence of graft migration;(viii) absence of graft integrity failure; (ix) at the level of the ostium of the LSA, the more proximal entry tear of the dissection, the largest section of the thoracic aorta, and at the first image/slice available with upper part of the liver:
Absence of true lumen decrease in diameter (≥ 5 mm is significant) Absence of increase in total aortic diameter (≥ 5 mm is significant)
|Study Start Date:||December 2006|
|Study Completion Date:||October 2012|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01213589
|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|