Endovascular Repair for the Descending Thoracic Aorta (ERRATA)
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|ClinicalTrials.gov Identifier: NCT02376998|
Recruitment Status : Completed
First Posted : March 3, 2015
Results First Posted : October 7, 2016
Last Update Posted : October 7, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Aorta Thoracic; Traumatic Rupture||Device: Valiant™ endoluminal procedure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endovascular Repair for Acute Traumatic Transection of the Descending Thoracic Aorta|
|Study Start Date :||November 2002|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||February 2015|
Experimental: Valiant™ endoluminal procedure
Data from early and long term complications following endoluminal stent-graft placement for thoracic endovascular aortic repair (TEVAR) procedure (Valiant™ endoluminal procedure) will be collected.
Device: Valiant™ endoluminal procedure
Thoracic endovascular aortic repair with Endoluminal stent-graft placement (Valiant™ endoluminal stent-graft systems (Medtronic Inc., Santa Rosa, CA, USA) will be performed as follows:
The diameter of the stent graft will be calculated from the largest diameter of the proximal/distal neck with an oversizing factor of 10-20%. The procedures will be done with local or general anaesthesia in case of unstable pre-operative hemodynamic conditions.
After the procedure will be completed, a digital subtraction angiography and echocardiography with color-flow mapping were performed to verify the correct positioning of the stent and to detect any primary endoleak.
- Number of Participants With Major Adverse Events [ Time Frame: from hospital discharge to 1 month after the procedure ]Evaluation of mortality, renal failure, cerebrovascular accident.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- patients with a diagnosis of acute transection of thoracic aorta;
- a time frame range from trauma of 1-10 hours.
- Patients who do not fall into the above categories
|Responsible Party:||Prof. Raffaele Serra, MD, Ph.D., Prof. Raffaele Serra, University of Catanzaro|
|Other Study ID Numbers:||
|First Posted:||March 3, 2015 Key Record Dates|
|Results First Posted:||October 7, 2016|
|Last Update Posted:||October 7, 2016|
|Last Verified:||August 2016|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Wounds and Injuries