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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valiant Thoracic Stent Graft with the Captivia Delivery System | Experimental | Valiant Thoracic Stent Graft with the Captivia Delivery System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valiant Thoracic Stent Graft with the Captivia Delivery System | Device | All subjects will be implanted with this device |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality Within 30-days of the Index Procedure | 30 days |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Rodney White, MD, FACS | Harbor UCLA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| Cedars Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25439771 | Derived | Khoynezhad A, Donayre CE, Azizzadeh A, White R; RESCUE investigators. One-year results of thoracic endovascular aortic repair for blunt thoracic aortic injury (RESCUE trial). J Thorac Cardiovasc Surg. 2015 Jan;149(1):155-61.e4. doi: 10.1016/j.jtcvs.2014.09.026. Epub 2014 Sep 19. | |
| 23384495 | Derived | 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. |
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All 50 subjects enrolled were implanted with the device (Valiant Thoracic Stent Graft with the Captivia Delivery System ).
A total of 25 investigational sites were activated and allowed to enroll in the RESCUE study in the US and Canada. A total of 50 subjects were enrolled at 20 of the 25 activated investigational sites, with the first enrollment on April 14, 2010 and the final enrollment on January 17, 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Valiant Thoracic Stent Graft With the Captivia Delivery System | Valiant Thoracic Stent Graft with the Captivia Delivery System : All subjects will be implanted with this device |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Los Angeles |
| California |
| 90048 |
| United States |
| Harbor UCLA | Torrance | California | 90502 | United States |
| Denver Health | Denver | Colorado | 80204 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| University of Florida Shands Hospital | Gainesville | Florida | 32608 | United States |
| University of Miami Jackson Memorial | Miami | Florida | 33136 | United States |
| Bayfront Medical Center | St. Petersburg | Florida | 33709 | United States |
| Maine Medical Center | Portland | Maine | 04105 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Cooper Health | Camden | New Jersey | 08103 | United States |
| Vascular Research Institute | Morristown | New Jersey | 07960 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Toledo Hospital / Jobst Vascular Center | Toledo | Ohio | 43606 | United States |
| UT Southwestern | Dallas | Texas | 75390 | United States |
| Memorial Hermann Heart and Vascular Institute | Houston | Texas | 77030 | United States |
| Brooke Army Medical Center | San Antonio | Texas | 78234 | United States |
| Scott and White Memorial | Temple | Texas | 76508 | United States |
| University Of Virginia | Charlottesville | Virginia | 22908 | United States |
| Sentara Norfolk General Vascular & Transplant Specialists | Norfolk | Virginia | 23507 | United States |
| Medical College of Wisconsin Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| London Health Sciences Center | London | Ontario | N6A5W9 | Canada |
| Laval Hospital | Québec | QCG1V | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Valiant Thoracic Stent Graft With the Captivia Delivery System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | All-cause Mortality Within 30-days of the Index Procedure | Posted | Number | participants | 30 days |
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12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1. Rescue | Rescue | 8 | 50 | 0 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Multiple Injuries | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Traumatic Brain Injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Anoxic Encephalopathy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Femoral Artery Dissection | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Intermittent Claudication | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Peripheral Ischaemia | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
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The Principal Investigator (PI) and institution agree not to publish the results of the study until after the earliest of the following: a)conclusion of the study, b)the early termination of the study, c)at discretion and approval of the sponsor, or d)after sponsor confirms there will be no multicenter study publication, whichever occurs first. PI and institution further agree to submit to sponsor copies of any proposed publication or public presentation at least sixty days before dissemination.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Regan, MPH - Study Lead | Medtronic, Inc., Aortic and Peripheral Vascular | 707-591-2743 | laura.e.regan@medtronic.com |
| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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