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

Primary Purpose

Blunt Thoracic Aortic Injury

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Valiant Thoracic Stent Graft with the Captivia Delivery System
Sponsored by
Medtronic Cardiovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blunt Thoracic Aortic Injury focused on measuring Thoracic Aneurysm, Thoracic Transection, Endovascular Aortic Repair

Eligibility Criteria

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

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

Sites / Locations

  • University of Alabama
  • Cedars Sinai Medical Center
  • Harbor UCLA
  • Denver Health
  • Yale New Haven Hospital
  • University of Florida Shands Hospital
  • University of Miami Jackson Memorial
  • Bayfront Medical Center
  • Maine Medical Center
  • Beth Israel Deaconess Medical Center
  • University of Michigan
  • William Beaumont Hospital
  • Cooper Health
  • Vascular Research Institute
  • Duke University Medical Center
  • Toledo Hospital / Jobst Vascular Center
  • UT Southwestern
  • Memorial Hermann Heart and Vascular Institute
  • Brooke Army Medical Center
  • Scott and White Memorial
  • University Of Virginia
  • Sentara Norfolk General Vascular & Transplant Specialists
  • Medical College of Wisconsin Froedtert Hospital
  • London Health Sciences Center
  • Laval Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Valiant Thoracic Stent Graft with the Captivia Delivery System

Arm Description

Valiant Thoracic Stent Graft with the Captivia Delivery System

Outcomes

Primary Outcome Measures

All-cause Mortality Within 30-days of the Index Procedure

Secondary Outcome Measures

Full Information

First Posted
March 16, 2010
Last Updated
October 27, 2021
Sponsor
Medtronic Cardiovascular
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT01092767
Brief Title
Study to Determine if the Valiant Stent Graft is Safe and Effective in Treating Patients Who Have a Blunt Thoracic Aortic Injury
Acronym
RESCUE
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 2010 (Actual)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blunt Thoracic Aortic Injury
Keywords
Thoracic Aneurysm, Thoracic Transection, Endovascular Aortic Repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Valiant Thoracic Stent Graft with the Captivia Delivery System
Arm Type
Experimental
Arm Description
Valiant Thoracic Stent Graft with the Captivia Delivery System
Intervention Type
Device
Intervention Name(s)
Valiant Thoracic Stent Graft with the Captivia Delivery System
Intervention Description
All subjects will be implanted with this device
Primary Outcome Measure Information:
Title
All-cause Mortality Within 30-days of the Index Procedure
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodney White, MD, FACS
Organizational Affiliation
Harbor UCLA
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Harbor UCLA
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Denver Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
University of Florida Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
University of Miami Jackson Memorial
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Bayfront Medical Center
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04105
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Cooper Health
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Vascular Research Institute
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Toledo Hospital / Jobst Vascular Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
UT Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Memorial Hermann Heart and Vascular Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Brooke Army Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Scott and White Memorial
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
University Of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Sentara Norfolk General Vascular & Transplant Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Medical College of Wisconsin Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
London Health Sciences Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5W9
Country
Canada
Facility Name
Laval Hospital
City
Quebec
ZIP/Postal Code
QCG1V
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25439771
Citation
Khoynezhad A, Donayre CE, Azizzadeh A, White R; RESCUE investigators. One-year results of thoracic endovascular aortic repair for blunt thoracic aortic injury (RESCUE trial). J Thorac Cardiovasc Surg. 2015 Jan;149(1):155-61.e4. doi: 10.1016/j.jtcvs.2014.09.026. Epub 2014 Sep 19.
Results Reference
derived
PubMed Identifier
23384495
Citation
Khoynezhad A, Azizzadeh A, Donayre CE, Matsumoto A, Velazquez O, White R; RESCUE investigators. Results of a multicenter, prospective trial of thoracic endovascular aortic repair for blunt thoracic aortic injury (RESCUE trial). J Vasc Surg. 2013 Apr;57(4):899-905.e1. doi: 10.1016/j.jvs.2012.10.099. Epub 2013 Feb 4.
Results Reference
derived

Learn more about this trial

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

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