Study to Determine if the Valiant Stent Graft is Safe and Effective in Treating Patients Who Have a Blunt Thoracic Aortic Injury (RESCUE)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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) |
- All patients are alive [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
| Estimated 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 |
Inclusion Criteria:
• Subject has a blunt thoracic aortic injury.
Exclusion Criteria:
- Subject has received a previous stent or stent graft or previous surgical repair in the descending thoracic artery (DTA).
- Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
- Subject has a known allergy or intolerance to the device components.
- Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
Contacts and Locations
Show 25 Study Locations| 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 |
| Last Updated: | January 25, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Medtronic Endovascular:
|
Thoracic Aneurysm Thoracic Transection Endovascular Aortic Repair |
ClinicalTrials.gov processed this record on June 13, 2013