Endovascular Repair for the Descending Thoracic Aorta

Not Applicable

Completed

• Conditions: Aorta Thoracic; Traumatic Rupture
• Interventions: Device: Valiant™ endoluminal procedure

• Registration Number: NCT02376998
• Lead Sponsor: 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

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.

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2014-11
• Study Completion: 2015-02
• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-02-25
• Study First Posted: 2015-03-03
• Results First Submitted: 2016-05-24
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-15
• Last Update Submitted: 2016-08-15
• Results First Posted: 2016-10-07
• Last Update Posted: 2016-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Valiant™ endoluminal procedure	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Major Adverse Events	from hospital discharge to 1 month after the procedure	Evaluation of mortality, renal failure, cerebrovascular accident.