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The VIRTUE Post Marketing Surveillance Registry

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01213589
First received: October 1, 2010
Last updated: October 21, 2013
Last verified: October 2013

October 1, 2010
October 21, 2013
December 2006
October 2012   (final data collection date for primary outcome measure)
Disease-, Procedure- or Device-related Mortality at 12 Months Post-procedure [ Time Frame: 12 months post-procedure ] [ Designated as safety issue: Yes ]
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.
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.
Complete list of historical versions of study NCT01213589 on ClinicalTrials.gov Archive Site
  • 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 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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)

  • 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
Not Provided
Not Provided
 
The VIRTUE Post Marketing Surveillance Registry
The VIRTUE Post Marketing Surveillance Registry - VALIANT Thoracic Stent Graft Evaluation For the Treatment of Descending Thoracic Aortic Dissections

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation will be enrolled in the registry.

Aortic Dissection
Not Provided
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.
Virtue Registry Investigators. The VIRTUE Registry of type B thoracic dissections--study design and early results. Eur J Vasc Endovasc Surg. 2011 Feb;41(2):159-66. Epub 2010 Oct 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2012
October 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01213589
MDTVIRTUE001
Yes
Medtronic Endovascular
Medtronic Endovascular
Not Provided
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
Medtronic Endovascular
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP