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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
University of Catanzaro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aorta Thoracic; Traumatic Rupture focused on measuring Thoracic Aorta, Trauma, Endovascular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    February 12, 2015
    Last Updated
    August 15, 2016
    Sponsor
    University of Catanzaro
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    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

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    Endovascular Repair for the Descending Thoracic Aorta

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