Blunt Thoracic Aortic InjuryRESCUENCT01092767
Study to Determine if the Valiant Stent Graft is Safe and Effective in Treating Patients Who Have a Blunt Thoracic Aortic Injury
A study testing Valiant Thoracic Stent Graft with the Captivia Delivery System in people with Blunt Thoracic Aortic Injury, run by Medtronic Cardiovascular at 25 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blunt Thoracic Aortic Injury
- What is being tested?
- Valiant Thoracic Stent Graft with the Captivia Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Apr 2010to May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States23 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Alabama
Birmingham, Alabama, 35294
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Cooper Health
Camden, New Jersey, 08103
University Of Virginia
Charlottesville, Virginia, 22908
UT Southwestern
Dallas, Texas, 75390
Denver Health
Denver, Colorado, 80204
Duke University Medical Center
Durham, North Carolina, 27710
University of Florida Shands Hospital
Gainesville, Florida, 32608
Memorial Hermann Heart and Vascular Institute
Houston, Texas, 77030
Cedars Sinai Medical Center
Los Angeles, California, 90048
University of Miami Jackson Memorial
Miami, Florida, 33136
Medical College of Wisconsin Froedtert Hospital
Milwaukee, Wisconsin, 53226
Vascular Research Institute
Morristown, New Jersey, 07960
Yale New Haven Hospital
New Haven, Connecticut, 06510
Sentara Norfolk General Vascular & Transplant Specialists
Norfolk, Virginia, 23507
Maine Medical Center
Portland, Maine, 04105
William Beaumont Hospital
Royal Oak, Michigan, 48073
Brooke Army Medical Center
San Antonio, Texas, 78234
Bayfront Medical Center
St. Petersburg, Florida, 33709
Scott and White Memorial
Temple, Texas, 76508
Toledo Hospital / Jobst Vascular Center
Toledo, Ohio, 43606
Harbor UCLA
Torrance, California, 90502
Canada2 sites
London Health Sciences Center
London, Ontario, N6A5W9
Laval Hospital
Québec, QCG1V
About this study
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)
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.
- Conditions
- Blunt Thoracic Aortic Injury
- Being tested
- Valiant Thoracic Stent Graft with the Captivia Delivery System
- Keywords
- Thoracic Aneurysm, Thoracic Transection, Endovascular Aortic Repair
- Medical subject headings
- Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valiant Thoracic Stent Graft with the Captivia Delivery SystemDevice
All subjects will be implanted with this device
| Study group | Role | What they receive |
|---|---|---|
| Valiant Thoracic Stent Graft with the Captivia Delivery System | Experimental | Valiant Thoracic Stent Graft with the Captivia Delivery System Receives: Device: Valiant Thoracic Stent Graft with the Captivia Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause Mortality Within 30-days of the Index Procedure
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2012
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blunt Thoracic Aortic InjuryStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Rodney White, MD, FACS, Principal investigator, Harbor UCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092767
- Sponsor's protocol ID
- Investigational Plan #117
- Acronym
- RESCUE
- Status last verified
- Oct 2021
- First submitted
- 16 Mar 2010
- Last updated
- 29 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 25439771Khoynezhad 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.
PubMed 23384495
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01092767
- Acronym / sponsor ID
- RESCUE / Investigational Plan #117
- Conditions
- Blunt Thoracic Aortic Injury
- Keywords
- Thoracic Aneurysm, Thoracic Transection, Endovascular Aortic Repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Apr 2010 (actual)
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 25 Mar 2010 (estimated)
- Results
- Posted 28 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valiant Thoracic Stent Graft with the Captivia Delivery System | Experimental | Device: Valiant Thoracic Stent Graft with the Captivia Delivery SystemValiant Thoracic Stent Graft with the Captivia Delivery System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valiant Thoracic Stent Graft with the Captivia Delivery SystemAll subjects will be implanted with this device | Device | Valiant Thoracic Stent Graft with the Captivia Delivery System |
Primary outcome
All-cause Mortality Within 30-days of the Index Procedure
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25439771Khoynezhad 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.
- Derived from this study: PubMed 23384495Khoynezhad 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.
Related trials for Blunt Thoracic Aortic Injury
Active, not recruitingObservational study
Blunt Traumatic Aortic Injury
Blunt Traumatic Aortic Injury, BTAI
RecruitingObservational study
Transesophageal Echocardiography To Diagnose Blunt Traumatic Aortic Injury Traumatic Aortic Injury
Trauma Chest
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodney White, MD, FACS principal investigator
Harbor UCLA
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valiant Thoracic Stent Graft with the Captivia Delivery System in people with Blunt Thoracic Aortic Injury, run by Medtronic Cardiovascular at 25 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause Mortality Within 30-days of the Index Procedure (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01092767, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.