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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01092767
First received: March 16, 2010
Last updated: February 13, 2014
Last verified: January 2014
  Purpose

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 Intervention
Blunt Thoracic Aortic Injury
Device: Valiant Thoracic Stent Graft with the Captivia Delivery System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • All-cause Mortality Within 30-days of the Index Procedure [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: April 2010
Estimated Study Completion Date: May 2017
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01092767

  Show 25 Study Locations
Sponsors and Collaborators
Medtronic Endovascular
Medtronic
Investigators
Principal Investigator: Rodney White, M.D., F.A.C.S. Harbor UCLA
  More Information

No publications provided by Medtronic Endovascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01092767     History of Changes
Other Study ID Numbers: Investigational Plan #117
Study First Received: March 16, 2010
Results First Received: February 13, 2014
Last Updated: February 13, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on April 23, 2014