The VIRTUE Post Marketing Surveillance Registry

Aortic Dissection Clinical Trial

— VIRTUE  

Official title:

The VIRTUE Post Marketing Surveillance Registry - VALIANT Thoracic Stent Graft Evaluation For the Treatment of Descending Thoracic Aortic Dissections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01213589
• Other study ID #: MDTVIRTUE001
• Status: Completed
• Phase: N/A
• First received: October 1, 2010
• Last updated: October 21, 2013
• Start date: December 2006
• Est. completion date: October 2012

Study information

• Verified date: October 2013
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeGermany: Ethics CommissionItaly: Ethics CommitteeNetherlands: Medical Ethics Review Committee (METC)Spain: Ethics CommitteeSwitzerland: EthikkommissionSweden: Regional Ethical Review BoardUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Dissection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-, Procedure- or Device-related Mortality at 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.	12 months post-procedure	Yes
Secondary	Safety	All causes mortality; Disease-, procedure- or device-related mortality	30 days or at discharge, 3/6/12/24/36 months	Yes
Secondary	Efficacy/Performance	- 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	30 days or at discharge, 3/6/12/24/36 months	Yes
Secondary	Freedom of Re-intervention	Kaplan-Meier estimate of freedom from secondary procedures by clinical group.	30 days or at discharge, 3/6/12/24/36 months	Yes
Secondary	Freedom From Disease-, Procedure- or Device-related Major Complications	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.	through 36 months	Yes
Secondary	Freedom From Disease-, Procedure-, or Device-related Severe Complications	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	through 36 months	Yes
Secondary	Clinical Success	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)	through 36 months	Yes