Blunt Thoracic Aortic InjuryRESCUENCT01092767

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

A study testing Valiant Thoracic Stent Graft with the Captivia Delivery System in people with Blunt Thoracic Aortic Injury, run by Medtronic Cardiovascular at 25 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Blunt Thoracic Aortic Injury
What is being tested?: Valiant Thoracic Stent Graft with the Captivia Delivery System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 25 sitesin 2 countries
Study dates: Apr 2010to May 2017
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

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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

Trial locations and contacts

25 sites in 2 countries.

Country

City, postcode or hospital

25 sites in 2 countries

United States23 sites

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

Other trials in United States

Canada2 sites

London Health Sciences Center
London, Ontario, N6A5W9
Laval Hospital
Québec, QCG1V

Other trials in Canada

About this study

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)

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.

Conditions: Blunt Thoracic Aortic Injury
Being tested: Valiant Thoracic Stent Graft with the Captivia Delivery System
Keywords: Thoracic Aneurysm, Thoracic Transection, Endovascular Aortic Repair
Medical subject headings: Aortic Aneurysm, Thoracic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Valiant Thoracic Stent Graft with the Captivia Delivery SystemDevice
All subjects will be implanted with this device

Study groups in NCT01092767
Study group	Role	What they receive
Valiant Thoracic Stent Graft with the Captivia Delivery System	Experimental	Valiant Thoracic Stent Graft with the Captivia Delivery System Receives: Device: Valiant Thoracic Stent Graft with the Captivia Delivery System

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010May 2017

First posted25 Mar 2010 (estimated)
Study startApr 2010
Primary completionApr 2012
Study completionMay 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Blunt Thoracic Aortic InjuryStudies of the same condition, open and under way.
More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01092767
Sponsor's protocol ID: Investigational Plan #117
Acronym: RESCUE
Status last verified: Oct 2021
First submitted: 16 Mar 2010
Last updated: 29 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 25439771
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.
PubMed 23384495