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: July 28, 2014
Last verified: July 2014

March 16, 2010
July 28, 2014
April 2010
April 2012   (final data collection date for primary outcome measure)
All-cause Mortality Within 30-days of the Index Procedure [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
All patients are alive [ Time Frame: Up to 30 days after implant ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01092767 on ClinicalTrials.gov Archive Site
Not Provided
  • Successful delivery and deployment of the stent graft [ Time Frame: 30 days after implant ] [ Designated as safety issue: Yes ]
  • Device, procedure and/or aortic related adverse events [ Time Frame: Up to 30 days after implant ] [ Designated as safety issue: Yes ]
  • Aortic related mortality (defined as: death caused by the underlying thoracic aortic injury and/or from any procedure intended to treat the aortic injury) [ Time Frame: Up to 30 days after implant ] [ Designated as safety issue: Yes ]
  • Any procedure, conducted in addition to the initial procedure, based on the judgement of the physician. [ Time Frame: Up to 60 months after implant ] [ Designated as safety issue: Yes ]
  • Device, procedure and/or aortic related serious adverse events [ Time Frame: Up to 60 months after implant ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: Up to 60 months after implant ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study to Determine if the Valiant Stent Graft is Safe and Effective in Treating Patients Who Have a Blunt Thoracic Aortic Injury
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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Blunt Thoracic Aortic Injury
Device: Valiant Thoracic Stent Graft with the Captivia Delivery System
All subjects will be implanted with this device
Experimental: Valiant Thoracic Stent Graft with the Captivia Delivery System
Intervention: Device: Valiant Thoracic Stent Graft with the Captivia Delivery System
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
May 2017
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01092767
Investigational Plan #117
Yes
Medtronic Endovascular
Medtronic Endovascular
Medtronic
Principal Investigator: Rodney White, M.D., F.A.C.S. Harbor UCLA
Medtronic Endovascular
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP