Endovascular Repair for the Descending Thoracic Aorta (ERRATA)
Primary Purpose
Aorta Thoracic; Traumatic Rupture
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Valiant™ endoluminal procedure
Sponsored by
About this trial
This is an interventional treatment trial for Aorta Thoracic; Traumatic Rupture focused on measuring Thoracic Aorta, Trauma, Endovascular
Eligibility Criteria
Inclusion Criteria:
- patients with a diagnosis of acute transection of thoracic aorta;
- a time frame range from trauma of 1-10 hours.
Exclusion Criteria:
- Patients who do not fall into the above categories
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Valiant™ endoluminal procedure
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Participants With Major Adverse Events
Evaluation of mortality, renal failure, cerebrovascular accident.
Secondary Outcome Measures
Full Information
NCT ID
NCT02376998
First Posted
February 12, 2015
Last Updated
August 15, 2016
Sponsor
University of Catanzaro
1. Study Identification
Unique Protocol Identification Number
NCT02376998
Brief Title
Endovascular Repair for the Descending Thoracic Aorta
Acronym
ERRATA
Official Title
Endovascular Repair for Acute Traumatic Transection of the Descending Thoracic Aorta
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catanzaro
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Most blunt aortic injuries occur in the proximal proximal descending aorta causing acute transection of this vessel. Generally, surgical repair of the ruptured segment of aorta is associated with high rates of morbidity and mortality and in this view endovascular treatment seems to be a valid and safer alternative. Aim of this study is to review the experience of a single center with endovascular approach for the treatment of acute traumatic rupture of descending thoracic aorta
Detailed Description
From April 2002 to November 2014, patients referred to our Department with a diagnosis of acute transection of thoracic aorta will be studied by preoperative Computed Tomography (CT) evaluation in order to perform thoracic endovascular aortic repair (TEVAR) with left subclavian artery coverage. Then patients will be followed up with clinical and instrumental (CT, Duplex ultrasound) controls at discharge, 1, 3 and 6 months and yearly thereafter. We will evaluate the presence of major and minor neurological complications, episodes of left arm claudication, cardiovascular, respiratory and bleeding complications. Furthermore we will evaluate the technical success of the technique evaluating the onset of failure, collapse, leak or distal migration of the graft.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aorta Thoracic; Traumatic Rupture
Keywords
Thoracic Aorta, Trauma, Endovascular
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Valiant™ endoluminal procedure
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Valiant™ endoluminal procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Major Adverse Events
Description
Evaluation of mortality, renal failure, cerebrovascular accident.
Time Frame
from hospital discharge to 1 month after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with a diagnosis of acute transection of thoracic aorta;
a time frame range from trauma of 1-10 hours.
Exclusion Criteria:
Patients who do not fall into the above categories
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26590963
Citation
Serra R, de Franciscis S, Grande R, Butrico L, Perri P, Indolfi C, Mastroroberto P. Endovascular repair for acute traumatic transection of the descending thoracic aorta: experience of a single centre with a 12-years follow up. J Cardiothorac Surg. 2015 Nov 21;10:171. doi: 10.1186/s13019-015-0388-5.
Results Reference
derived
Learn more about this trial
Endovascular Repair for the Descending Thoracic Aorta
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