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
  Purpose

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.


Condition
Aortic Dissection

Study Type: Observational
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

Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)



Enrollment: 100
Study Start Date: December 2006
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01213589

Sponsors and Collaborators
Medtronic Endovascular
Investigators
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
  More Information

Publications:
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01213589     History of Changes
Other Study ID Numbers: MDTVIRTUE001
Study First Received: October 1, 2010
Results First Received: October 21, 2013
Last Updated: October 21, 2013
Health Authority: Belgium: Ethics Committee
Germany: Ethics Commission
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Spain: Ethics Committee
Switzerland: Ethikkommission
Sweden: Regional Ethical Review Board
United Kingdom: Research Ethics Committee

Keywords provided by Medtronic Endovascular:
descending
thoracic
aortic
dissection
Valiant
Medtronic
Type B
VIRTUE
stent

ClinicalTrials.gov processed this record on October 22, 2014