Endovascular Repair for the Descending Thoracic Aorta (ERRATA)

University of Catanzaro

Status: Completed

Conditions: Aorta Thoracic; Traumatic Rupture

Treatments: Device: Valiant™ endoluminal procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT02376998

ERRATASTUDY

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Valiant™ endoluminal procedure

Experimental group

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.

Treatment:

Device: Valiant™ endoluminal procedure