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

Covidien

Status

Completed

Conditions

Blunt Thoracic Aortic Injury

Treatments

Device: Valiant Thoracic Stent Graft with the Captivia Delivery System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01092767

Investigational Plan #117

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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