Endovascular Repair for the Descending Thoracic Aorta (ERRATA)

August 15, 2016 updated by: Prof. Raffaele Serra, MD, Ph.D., University of Catanzaro

Endovascular Repair for Acute Traumatic Transection of the Descending Thoracic Aorta

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from hospital discharge to 1 month after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Catanzaro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 12, 2015

First Submitted That Met QC Criteria

February 25, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Estimate)

October 7, 2016

Last Update Submitted That Met QC Criteria

August 15, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERRATASTUDY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aorta Thoracic; Traumatic Rupture

Clinical Trials on Valiant™ endoluminal procedure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe