The VIRTUE Post Marketing Surveillance Registry

NCT01213589 | Completed Results DMC

• 1 other identifier: MDTVIRTUE001
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aortic Dissection

Keywords

descending; thoracic; aortic; dissection; Valiant; Medtronic; Type B; VIRTUE; stent

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Safety

  30 days or at discharge, 3/6/12/24/36 months

• Efficacy/Performance

  30 days or at discharge, 3/6/12/24/36 months

• Freedom of Re-intervention

  30 days or at discharge, 3/6/12/24/36 months

• Freedom From Disease-, Procedure- or Device-related Major Complications

  through 36 months

• Freedom From Disease-, Procedure-, or Device-related Severe Complications

  through 36 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medtronic Endovascular: lead

Related 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.

  PMID: 20952217 RESULT

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Results Point of Contact

• Title: Richard Jonkers, PhD
• Organization: Medtronic

richard.jonkers@medtronic.com

800-217-1617

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• R. Heijmen, Dr.

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

• N. Cheshire, Prof.

  St Mary's NHS Trust

  PRINCIPAL INVESTIGATOR

• C. Nienaber, Dr

  University School of Medicine Rostock

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 4, 2010
• Study Start: December 1, 2006
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 11, 2013
• Results First Posted: December 11, 2013

Record last verified: 2013-10