Valor II: The Valiant Thoracic Stent Graft System Clinical Study
NCT ID: NCT00413231
Last Updated: 2021-11-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
160 participants
INTERVENTIONAL
2006-12-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Valiant Thoracic Stent Graft System
160 subjects were enrolled into the study, including 157 subjects treated with the study device and three subjects classified as intent-to-treat who did not receive the study device.
There were no other arms for this study.
Valiant Thoracic Stent Graft System
Surgical procedure in which a device is implanted inside the aorta, isolating the diseased area (aneurysm).
Interventions
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Valiant Thoracic Stent Graft System
Surgical procedure in which a device is implanted inside the aorta, isolating the diseased area (aneurysm).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject must be considered a candidate for elective surgical repair of the TAA (i.e., low-to-moderate risk \[categories 0, 1, and 2\] per the modified SVS/AAVS scoring system at the time of implant). See Appendix B: Modified SVS/AAVS Medical Co-Morbidity Grading System
3. If subject is female of childbearing potential, she must have a negative pregnancy test within 7 days before the implant procedure.
4. Subject has a DTA that is:
1. A fusiform aneurysm with a maximum diameter of ≥ 5 cm OR is \> 2 times the diameter of the non-aneurysmal thoracic aorta;
AND/OR
2. Saccular aneurysm (penetrating atherosclerotic ulcer)
5. Subject's anatomy must meet all of the following anatomical criteria:
1. Subject's TAA must be ≥ 20 mm distal to the origin of the left common carotid artery and must be ≥ 20 mm proximal to the celiac artery;
2. Proximal and distal non-aneurysmal neck diameter measurements must be between 20 mm and 42 mm;
3. Proximal and distal non-aneurysmal neck must be ≥ 20 mm in length.
6. Thoracic aortic lesion is confirmed, at a minimum, by diagnostic contrast enhanced computerized tomography (CT) with optional 3-D reconstruction, and/or contrast enhanced Magnetic Resonance Angiogram obtained within four (4) months prior to the implant procedure.
7. Subject is able and willing to comply with the protocol and undergo follow-up requirements.
8. Subject or subject's legal representative understands and has signed an Informed Consent approved by the Sponsor and by the IRB for this study.
9. Subject has patent iliac or femoral arteries or can tolerate a vascular conduit that allows endovascular access to the aneurysmal site with the delivery system of the appropriate size device chosen for treatment.
Exclusion Criteria
2. Subject has a thoracic aneurysm with a contained rupture.
3. Subject has a connective tissue disease (e.g., Marfan's syndrome, aortic medial degeneration).
4. Subject has a mycotic aneurysm or is suspected of having systemic infection.
5. Subject has received a previous stent or stent graft or previous surgical repair in the DTA.
6. Subject requires treatment of an infra-renal aneurysm at the time of implant.
7. Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
8. Subject has had or plans to have a major surgical procedure within 30 days before or after the Valiant Stent Graft procedure. This does not include planned procedures that are needed for the safe and effective placement of the stent graft (i.e., carotid/subclavian transposition, carotid/subclavian bypass procedure).
9. Subject has had an MI or cerebral vascular accident (CVA) within 3 months.
10. Subject is currently participating in an investigational drug or device clinical trial.
11. Subject has a known allergy or intolerance to the device components.
12. Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
13. Subject has significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment sites that would compromise fixation and seal of the device.
14. Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude him or her from receiving this treatment and the procedures and evaluations pre- and post-treatment, or a limited life expectancy of less than 1 year.
18 Years
85 Years
ALL
No
Sponsors
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Medtronic Cardiovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Ronald Fairman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Southern California - Healthcare Consultation Center
Los Angeles, California, United States
Los Angeles Biomedical Research Institute @ Harbor-UCLA Medical Center
Torrance, California, United States
Hartford Hospital
Hartford, Connecticut, United States
University of Florida
Gainesville, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Loyola University Medical Center
Maywood, Illinois, United States
Union Memorial
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Minneapolis Vascular Physicians
Plymouth, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Advance Vascular Associates (Morristown Memorial Hospital)
Morristown, New Jersey, United States
Albany Medical Center
Albany, New York, United States
New York University Medical Center
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Shadyside Hospital - University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Baptist Memorial Hospital
Memphis, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
St. Luke's Episcopal Hospital - Houston
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Countries
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References
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Conrad MF, Tuchek J, Freezor R, Bavaria J, White R, Fairman R. Results of the VALOR II trial of the Medtronic Valiant Thoracic Stent Graft. J Vasc Surg. 2017 Aug;66(2):335-342. doi: 10.1016/j.jvs.2016.12.136. Epub 2017 Mar 30.
Other Identifiers
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Investigational Plan #078
Identifier Type: -
Identifier Source: org_study_id