Clinical trial NCT01213589: The VIRTUE Post Marketing Surveillance Registry
Official title: The VIRTUE Post Marketing Surveillance Registry - VALIANT Thoracic Stent Graft Evaluation For the Treatment of Descending Thoracic Aortic Dissections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Dissection
Keywords: descending
thoracic
aortic
dissection
Valiant
Medtronic
Type B
VIRTUE
stent
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2010-10-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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 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).

Primary outcomes:
measure: Disease-, Procedure- or Device-related Mortality at 12 Months Post-procedure
timeFrame: 12 months post-procedure
Secondary outcomes:
measure: Safety
timeFrame: 30 days or at discharge, 3/6/12/24/36 months
measure: Efficacy/Performance
timeFrame: 30 days or at discharge, 3/6/12/24/36 months
measure: Freedom of Re-intervention
timeFrame: 30 days or at discharge, 3/6/12/24/36 months
measure: Freedom From Disease-, Procedure- or Device-related Major Complications
timeFrame: through 36 months
measure: Freedom From Disease-, Procedure-, or Device-related Severe Complications
timeFrame: through 36 months
measure: Clinical Success
timeFrame: through 36 months
Other outcomes:
Locations:
Study officials:
affiliation: St George's Hospital
name: M. Thompson, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera "Santa Maria della Misericordia"
name: D. Gasparini, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Sant'Orsola Malpighi
name: R. Fattori, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Unità di Chirurgia Vascolare, Ospedale R. Silvestrini
name: P. Cao, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario La Paz
name: G. Garzón, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico Universitario San Cecilio
name: E. Ros, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Freiburg
name: B. Rylski, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Essen
name: S. Huptas, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Onze-Lieve-Vrouw Ziekenhuis
name: I. Degrieck, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsspital Bern, Inselspital
name: D. Dai-DoDo, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sahlgrenska University Hospital
name: H. Roos, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Antonius Hospital
name: R. Heijmen, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: St Mary's NHS Trust
name: N. Cheshire, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University School of Medicine Rostock
name: C. Nienaber, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.ejvs.2010.08.016. Epub 2010 Oct 16.