Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
100 participants
OBSERVATIONAL
2006-12-31
2012-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Medtronic Endovascular
INDUSTRY
Responsible Party
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Principal Investigators
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M. Thompson, Prof.
Role: PRINCIPAL_INVESTIGATOR
St George's Hospital
D. Gasparini, Dr.
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera "Santa Maria della Misericordia"
R. Fattori, Prof.
Role: PRINCIPAL_INVESTIGATOR
Ospedale Sant'Orsola Malpighi
P. Cao, Dr.
Role: PRINCIPAL_INVESTIGATOR
Unità di Chirurgia Vascolare, Ospedale R. Silvestrini
G. Garzón, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario La Paz
E. Ros, Prof.
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínico Universitario San Cecilio
B. Rylski, Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Freiburg
S. Huptas, Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Essen
I. Degrieck, Dr.
Role: PRINCIPAL_INVESTIGATOR
Onze-Lieve-Vrouw Ziekenhuis
D. Dai-DoDo, Prof.
Role: PRINCIPAL_INVESTIGATOR
Universitätsspital Bern, Inselspital
H. Roos, Dr.
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska University Hospital
R. Heijmen, Dr.
Role: PRINCIPAL_INVESTIGATOR
St. Antonius Hospital
N. Cheshire, Prof.
Role: PRINCIPAL_INVESTIGATOR
St Mary's NHS Trust
C. Nienaber, Dr
Role: PRINCIPAL_INVESTIGATOR
University School of Medicine Rostock
References
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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.
Other Identifiers
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MDTVIRTUE001
Identifier Type: -
Identifier Source: org_study_id