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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01092767
Recruitment Status : Completed
First Posted : March 25, 2010
Results First Posted : March 28, 2014
Last Update Posted : February 7, 2018
Information provided by (Responsible Party):
Medtronic Endovascular

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.

Condition or disease Intervention/treatment Phase
Blunt Thoracic Aortic Injury Device: Valiant Thoracic Stent Graft with the Captivia Delivery System Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : April 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : May 2017

Arm Intervention/treatment
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
All subjects will be implanted with this device

Primary Outcome Measures :
  1. All-cause Mortality Within 30-days of the Index Procedure [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01092767

  Show 25 Study Locations
Sponsors and Collaborators
Medtronic Endovascular
Principal Investigator: Rodney White, MD, FACS Harbor UCLA

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medtronic Endovascular Identifier: NCT01092767     History of Changes
Other Study ID Numbers: Investigational Plan #117
First Posted: March 25, 2010    Key Record Dates
Results First Posted: March 28, 2014
Last Update Posted: February 7, 2018
Last Verified: February 2018

Keywords provided by Medtronic Endovascular:
Thoracic Aneurysm
Thoracic Transection
Endovascular Aortic Repair

Additional relevant MeSH terms:
Wounds and Injuries