Valor II: The Valiant Thoracic Stent Graft System Clinical Study
The Valiant Thoracic Stent Graft System. The Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft System in the Treatment of Descending Thoracic Aneurysms of Degenerative Etiology in Subjects Who Are Candidates for Endovascular Repair.
1 other identifier
interventional
160
1 country
26
Brief Summary
This study was designed to study safety and effectiveness of the Valiant Thoracic Stent Graft to treat thoracic aortic aneurysms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2006
Longer than P75 for not_applicable
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 15, 2006
CompletedFirst Posted
Study publicly available on registry
December 19, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedResults Posted
Study results publicly available
April 5, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedNovember 3, 2021
October 1, 2021
3.7 years
December 15, 2006
December 23, 2011
October 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint)
Evaluation of the ARM-free rate in subjects implanted with the Valiant Thoracic Stent Graft five years post-implantation by comparing it to a pre-defined performance goal (PG) based on an analysis of ARM-free rates from TEVAR data and on results from the VALOR (Talent Thoracic Endoluminal Stent Graft, IDE G980116) clinical study.
0 through 1825 days post treatment
Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint)
Percentage of subjects with absence of both: a) aneurysm growth of more than 5 mm at the 12-month visit relative to the 1-month visit; and b) secondary procedure due to type I or III endoleak performed or recommended at or before the 12-month visit. Success means a subject experienced neither a nor b. Type I: endoleak in continuity with the proximal anchoring site(proximal endoleak) or the distal anchoring site(distal endoleak)of the device. Type III: endoleak is present in the mid-graft region due to defect of fabric or between the segments of the modular graft (junctional endoleak).
At 12-month post procedure
Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > >
The percentage of participants who died within 12-months of the initial procedure, whether or not the cause of death was related to the study device, procedure, or condition treated. \> \> Note: All-cause mortality endpoint is not directly related to successful aneurysm treatment, which pertains to the absence of aneurysm growth and secondary procedure due to Type I and III endoleaks.
Within 12-months post treatment
Secondary Outcomes (24)
Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant
At implant
Percentage of Participants That Experienced Perioperative Mortality
Within 30 days post treatment
Percentage of Participants That Experienced Paraplegia
Within 30 days post treatment
Percentage of Participants That Experienced Paraparesis
Within 30 days post treatment
Percentage of Participants That Experienced Secondary Procedures Due to Endoleak After Discharge
Within 30 days post treatment
- +19 more secondary outcomes
Study Arms (1)
Valiant Thoracic Stent Graft System
EXPERIMENTAL160 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.
Interventions
Surgical procedure in which a device is implanted inside the aorta, isolating the diseased area (aneurysm).
Eligibility Criteria
You may not qualify if:
- Subject is between the age of 18 and 85.
- 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
- If subject is female of childbearing potential, she must have a negative pregnancy test within 7 days before the implant procedure.
- Subject has a DTA that is:
- A fusiform aneurysm with a maximum diameter of ≥ 5 cm OR is \> 2 times the diameter of the non-aneurysmal thoracic aorta;
- AND/OR
- Saccular aneurysm (penetrating atherosclerotic ulcer)
- Subject's anatomy must meet all of the following anatomical criteria:
- 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;
- Proximal and distal non-aneurysmal neck diameter measurements must be between 20 mm and 42 mm;
- Proximal and distal non-aneurysmal neck must be ≥ 20 mm in length.
- 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.
- Subject is able and willing to comply with the protocol and undergo follow-up requirements.
- Subject or subject's legal representative understands and has signed an Informed Consent approved by the Sponsor and by the IRB for this study.
- 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.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of Southern California - Healthcare Consultation Center
Los Angeles, California, 90033, United States
Los Angeles Biomedical Research Institute @ Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Hartford Hospital
Hartford, Connecticut, 06106, United States
University of Florida
Gainesville, Florida, 32610, United States
University of South Florida
Tampa, Florida, 33606, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Union Memorial
Baltimore, Maryland, 21218, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Minneapolis Vascular Physicians
Plymouth, Minnesota, 55441, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Advance Vascular Associates (Morristown Memorial Hospital)
Morristown, New Jersey, 07960, United States
Albany Medical Center
Albany, New York, 12208, United States
New York University Medical Center
New York, New York, 10016, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Shadyside Hospital - University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Baptist Memorial Hospital
Memphis, Tennessee, 38120, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
St. Luke's Episcopal Hospital - Houston
Houston, Texas, 77030, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Related Publications (1)
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.
PMID: 28366302DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Adverse Events and Serious Adverse Events listed in ClinicalTrials.gov were re-coded, using MedDRA 13.1. To do so, events were reclassified. As a result, data in listings may not match those in Clinical Update reports, SSEDs, or Instructions for Use.
Results Point of Contact
- Title
- PJ Belmont, Clinical Research Specialist
- Organization
- Medtronic Vascular, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald Fairman, MD
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2006
First Posted
December 19, 2006
Study Start
December 1, 2006
Primary Completion
August 1, 2010
Study Completion
October 1, 2014
Last Updated
November 3, 2021
Results First Posted
April 5, 2012
Record last verified: 2021-10