Study to Determine if the Valiant Stent Graft is Safe and Effective in Treating Patients Who Have a Blunt Thoracic Aortic Injury (RESCUE)

October 27, 2021 updated by: Medtronic Cardiovascular

Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System for the Endovascular Treatment of Blunt Thoracic Aortic Injuries (RESCUE)

The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a blunt thoracic aortic injury (BTAI). BTAI is when the aorta has been injured due to traumatic force to the chest area. It is commonly caused by motor vehicle accidents. In most cases it is life threatening and the standard treatment is surgery. Many times when a person has a BTAI they also have other injuries that can affect the results of the surgery.

Since stent grafting has been an effective way to treat other aortic conditions such as aneurysms (bulge in aorta wall), it is believed that the Valiant stent graft would be effective in treating BTAI. A stent graft is a woven polyester tube (graft) supported by a metal frame of strong but flexible nitinol (type of metal) springs (stent) that is placed in the aorta to help seal the injury and keep it from bleeding.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, QCG1V
        • Laval Hospital
    • Ontario
      • London, Ontario, Canada, N6A5W9
        • London Health Sciences Center
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Torrance, California, United States, 90502
        • Harbor UCLA
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Hospital
    • Florida
      • Gainesville, Florida, United States, 32608
        • University of Florida Shands Hospital
      • Miami, Florida, United States, 33136
        • University of Miami Jackson Memorial
      • Saint Petersburg, Florida, United States, 33709
        • Bayfront Medical Center
    • Maine
      • Portland, Maine, United States, 04105
        • Maine Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Health
      • Morristown, New Jersey, United States, 07960
        • Vascular Research Institute
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Toledo, Ohio, United States, 43606
        • Toledo Hospital / Jobst Vascular Center
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern
      • Houston, Texas, United States, 77030
        • Memorial Hermann Heart and Vascular Institute
      • San Antonio, Texas, United States, 78234
        • Brooke Army Medical Center
      • Temple, Texas, United States, 76508
        • Scott and White Memorial
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Vascular & Transplant Specialists
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin Froedtert Hospital

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

  • Subject had a blunt thoracic aortic injury which:
  • was confirmed, at a minimum, by diagnostic contrast-enhanced computerized tomography angiogram (CTA) and/or contrast-enhanced magnetic resonance angiogram (MRA)
  • occurred no more than 30 days prior to the stent implant procedure
  • Subject was ≥ 18 years of age
  • Subject or subject's legally authorized representative signed an IRB approved informed consent
  • Subject was hemodynamically stable
  • Subject's anatomy met all of the following anatomical criteria:
  • Aortic diameter (adventitia to adventitia) of the proximal and distal landing zones between 18 mm and 44 mm
  • Subject had patent iliac or femoral arteries or could tolerate an iliac conduit that allowed endovascular access to the injury site with the delivery system of the appropriate sized device
  • The centerline distance from the distal margin of left common carotid artery (LCC) to the injury was ≥ 20 mm

Exclusion Criteria

  • Planned placement of the COVERED portion of the stent graft over the celiac axis or the LCC, or in cases of bovine anatomy, innominate artery
  • Subject had systemic infection
  • Subject was pregnant
  • Subject had received a previous stent or stent graft or previous surgical repair in the DTA
  • Subject had a history of bleeding diathesis, coagulopathy, or refuses blood transfusion
  • Subject was participating in an investigational drug or device clinical trial which would interfere with the endpoints and/or follow-ups of this study
  • Subject had a known allergy or intolerance to the device components
  • Subject had a known hypersensitivity or contraindication to anticoagulants or contrast media, which was not amenable to pre-treatment
  • Subject was in extremis, defined as subject that had non-survivable injury/condition
  • Subject had a Cerebral Vascular Accident (CVA) within two (2) months prior to implant procedure

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 Thoracic Stent Graft with the Captivia Delivery System
Device: Valiant Thoracic Stent Graft with the Captivia Delivery System
All subjects will be implanted with this device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause Mortality Within 30-days of the Index Procedure
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

Medtronic Cardiovascular

Collaborators

Medtronic

Investigators

  • Principal Investigator: Rodney White, MD, FACS, Harbor UCLA

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 (Actual)

April 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

March 16, 2010

First Submitted That Met QC Criteria

March 23, 2010

First Posted (Estimate)

March 25, 2010

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Investigational Plan #117

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.

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