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

Blunt Thoracic Aortic Injury Clinical Trial

— RESCUE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01092767
• Other study ID #: Investigational Plan #117
• Status: Completed
• Phase: N/A
• Start date: April 2010
• Est. completion date: May 2017

Study information

• Verified date: October 2021
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2017
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Blunt Thoracic Aortic Injury
• Wounds and Injuries

Intervention

Device:
• Valiant Thoracic Stent Graft with the Captivia Delivery System
All subjects will be implanted with this device

Locations

Country	Name	City	State
Canada	London Health Sciences Center	London	Ontario
Canada	Laval Hospital	Quebec
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Alabama	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Cooper Health	Camden	New Jersey
United States	University Of Virginia	Charlottesville	Virginia
United States	UT Southwestern	Dallas	Texas
United States	Denver Health	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Florida Shands Hospital	Gainesville	Florida
United States	Memorial Hermann Heart and Vascular Institute	Houston	Texas
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	University of Miami Jackson Memorial	Miami	Florida
United States	Medical College of Wisconsin Froedtert Hospital	Milwaukee	Wisconsin
United States	Vascular Research Institute	Morristown	New Jersey
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Sentara Norfolk General Vascular & Transplant Specialists	Norfolk	Virginia
United States	Maine Medical Center	Portland	Maine
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Bayfront Medical Center	Saint Petersburg	Florida
United States	Brooke Army Medical Center	San Antonio	Texas
United States	Scott and White Memorial	Temple	Texas
United States	Toledo Hospital / Jobst Vascular Center	Toledo	Ohio
United States	Harbor UCLA	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Cardiovascular	Medtronic

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Mortality Within 30-days of the Index Procedure		30 days