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Endovascular Repair for the Descending Thoracic Aorta (ERRATA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02376998
Recruitment Status : Completed
First Posted : March 3, 2015
Results First Posted : October 7, 2016
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):
Prof. Raffaele Serra, MD, Ph.D., University of Catanzaro

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

Condition or disease Intervention/treatment Phase
Aorta Thoracic; Traumatic Rupture Device: Valiant™ endoluminal procedure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Raffaele Serra, MD, Ph.D., Prof. Raffaele Serra, University of Catanzaro
ClinicalTrials.gov Identifier: NCT02376998    
Other Study ID Numbers: ERRATASTUDY
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
Keywords provided by Prof. Raffaele Serra, MD, Ph.D., University of Catanzaro:
Thoracic Aorta
Trauma
Endovascular
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries