CompletedNCT01092767RESCUEUpdated Oct 29, 2021Results posted

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

An interventional study of Valiant Thoracic Stent Graft with the Captivia Delivery System in Blunt Thoracic Aortic Injury, sponsored by Medtronic Cardiovascular. Completed at 25 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-29.

Sponsored by Medtronic Cardiovascular · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 50
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Blunt Thoracic Aortic Injury

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Keywords

Thoracic Aneurysm
Thoracic Transection
Endovascular Aortic Repair

In context

Aortic Dissection

386 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.

This study's enrollment of 50 is below the median of 84 across 198 interventional studies indexed under Aortic Dissection.

Browse Aortic Dissection studies →

Lead sponsor

Medtronic Cardiovascular is the lead sponsor of 66 studies on the registry; 7 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 50 participants (actual)

Study arms

Experimental
Valiant Thoracic Stent Graft with the Captivia Delivery System
Valiant Thoracic Stent Graft with the Captivia Delivery System
Device: Valiant Thoracic Stent Graft with the Captivia Delivery System

Interventions

DeviceValiant Thoracic Stent Graft with the Captivia Delivery System
All subjects will be implanted with this device

What researchers measure

Primary outcomes

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

Results

Posted Mar 28, 2014

Participant flow

A total of 25 investigational sites were activated and allowed to enroll in the RESCUE study in the US and Canada. A total of 50 subjects were enrolled at 20 of the 25 activated investigational sites, with the first enrollment on April 14, 2010 and the final enrollment on January 17, 2012.

Participant flow — Overall Study
Milestone	Valiant Thoracic Stent Graft With the Captivia Delivery System
Started	50
Completed	45
Not completed	5

Outcome measures

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

Time frame:: 30 days
Reported as:: Number · participants

All-cause Mortality Within 30-days of the Index Procedure
participants	Valiant Thoracic Stent Graft With the Captivia Delivery System
All-cause Mortality Within 30-days of the Index Procedure	4

Adverse events

Collected over 12 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
1. Rescue	—	8/50 (16%)	0/50 (0%)

Most frequent serious events

Most frequent serious events
Event	1. Rescue
ArrhythmiaCardiac disorders	1/50
Multiple InjuriesInjury, poisoning and procedural complications	1/50
Traumatic Brain InjuryInjury, poisoning and procedural complications	1/50
Anoxic EncephalopathyNervous system disorders	1/50
HaemothoraxRespiratory, thoracic and mediastinal disorders	1/50
Femoral Artery DissectionVascular disorders	1/50
Intermittent ClaudicationVascular disorders	1/50
Peripheral IschaemiaVascular disorders	1/50
InfectionInfections and infestations	0/50

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Valiant Thoracic Stent Graft With the Captivia Delivery System
<=18 years	0
Between 18 and 65 years	43
>=65 years	7

Age, Continuous
Age, Continuous(years)	Valiant Thoracic Stent Graft With the Captivia Delivery System
Mean	40.7 ± 17.4

Sex: Female, Male
Sex: Female, Male(Participants)	Valiant Thoracic Stent Graft With the Captivia Delivery System
Female	12
Male	38

Region of Enrollment
Region of Enrollment(participants)	Valiant Thoracic Stent Graft With the Captivia Delivery System
United States	48
Canada	2

Study locations

25 sites

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

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01092767
Lead sponsor: Medtronic Cardiovascular
Collaborators: Medtronic
Responsible party: Sponsor
First posted: Mar 25, 2010
Start date: Apr 2010
Primary completion: Apr 2012
Completion: May 2017
Results posted: Mar 28, 2014
Last update: Oct 29, 2021

Study contacts

Rodney White, MD, FACS

principal investigator · Harbor UCLA

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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