Valor II: The Valiant Thoracic Stent Graft System Clinical Study

This study has been completed.
Information provided by (Responsible Party):
Medtronic Endovascular Identifier:
First received: December 15, 2006
Last updated: July 30, 2015
Last verified: July 2015
The aorta is a large blood vessel that carries blood away from the heart to the organs in the rest of the body. An aneurysm is a weakening in the artery wall that will become a bulge in the aorta. If left untreated, this bulge may continue to grow larger and may rupture (break open) with fatal consequences. In this research study we are investigating a device that can be placed in the aorta to exclude the weakened part of the artery wall and restore blood flow. Information will be collected on the performance of the device for 5 years.

Condition Intervention
Thoracic Aortic Aneurysm
Device: Valiant Thoracic Stent Graft System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • Primary Effectiveness Endpoint: Percentage of Participants With Successful Aneurysm Treatment. [ Time Frame: At 12-month post procedure ] [ Designated as safety issue: No ]

    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).

  • Primary Safety Endpoint: All-Cause Mortality. > > The Percentage of Participants Who Died of All Causes. [ Time Frame: Within 12-months post treatment ] [ Designated as safety issue: Yes ]

    The percentage of participants who died within 12-months of the initial procedure, regardless of the cause of death.


    > 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.

Secondary Outcome Measures:
  • Secondary Endpoints, Within 30 Days Post Treatment [ Time Frame: within 30 days post treatment ] [ Designated as safety issue: Yes ]
    • Peri-Operative Mortality
    • Paraplegia
    • Paraparesis
    • Secondary procedures due to an endoleak after discharge
    • One (1) or more Major Adverse Event(s) (MAE)

  • Secondary Endpoints, Within 12 Months Post Treatment [ Time Frame: Within 12 months post treatment ] [ Designated as safety issue: Yes ]
    • Aneurysm-Related Mortality
    • Secondary Endovascular Procedures due to an endoleak after 30 days post treatment
    • Conversion to open surgical repair
    • Migration of the stent graft
    • Loss of patency of the stent graft
    • Aneurysm rupture
    • Endoleaks
    • One (1) or more Major Adverse Event(s) (MAE)

  • Successful Deployment and Delivery of the Stent Graft [ Time Frame: N/A (at implant) ] [ Designated as safety issue: No ]
    Successful deployment and delivery of the stent graft is used to measure effectiveness

Enrollment: 160
Study Start Date: December 2006
Study Completion Date: October 2014
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Device: Valiant Thoracic Stent Graft System
Surgical procedure in which a device is implanted inside the aorta, isolating the diseased area (aneurysm).
Other Name: Valiant device; Valiant stent graft.


Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Subject is between the age of 18 and 85.
  • Subject must be considered a candidate for elective surgical repair of the thoracic aortic aneurysm (i.e., low-to-moderate risk at the time of implant.
  • If Subject is female of childbearing potential she must have a negative pregnancy test within 7 days befor0e the implanting procedure.
  • Subject has a Descending Thoracic Aneurysm that is: with a maximum diameter of 5 cm or larger; or is > 2 times the diameter of the non-aneurysmal thoracic aorta; or
  • Subject's anatomy must meet the protocol parameters
  • 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 the previous four (4) months prior to screening.
  • 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.


  • History of thoracic aneurysm with a contained rupture.
  • History of connective tissue disease
  • Systemic infection
  • Previous stent or stent graft or previous surgical repair in the descending thoracic aorta.
  • History of treatment of an infra-renal aneurysm
  • History of bleeding
  • Subject has had or plans to have a major surgical procedure within 30 days before or after the Valiant Stent Graft System implantation. This does not include planned procedures that are needed for the safe and effective placement of the stent graft.(i.e., carotid/subclavian transposition, bypass procedure).
  • Subject has had a recent MI or cerebral vascular accident (CVA) (within 3 months).
  • Subject is currently participating in an investigational drug or device clinical trial.
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00413231

  Hide Study Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of Southern California - Healthcare Consultation Center
Los Angeles, California, United States, 90033
Los Angeles Biomedical Research Institute @ Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06106
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
University of South Florida
Tampa, Florida, United States, 33606
United States, Georgia
Emory University Hospital
Altanta, Georgia, United States, 30322
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Maryland
Union Memorial
Baltimore, Maryland, United States, 21218
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Minneapolis Vascular Physicians
Plymouth, Minnesota, United States, 55441
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New Jersey
Advance Vascular Associates (Morristown Memorial Hospital)
Morristown, New Jersey, United States, 07960
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Mount Sinai School of Medicine
New York, New York, United States, 10029
New York University Medical Center
New York, New York, United States, 10016
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Shadyside Hospital - University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Baptist Memorial Hospital
Memphis, Tennessee, United States, 38120
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
St. Luke's Episcopal Hospital - Houston
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Medtronic Endovascular
Principal Investigator: Ronald Fairman, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Medtronic Endovascular Identifier: NCT00413231     History of Changes
Other Study ID Numbers: Investigational Plan #078
Study First Received: December 15, 2006
Results First Received: December 23, 2011
Last Updated: July 30, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Endovascular:
Thoracic Aneurysm
Endovascular Aortic Repair (EVAR)
Endovascular Stent Graft
Thoracic Aortic Aneurysm
Endovascular procedure
Descending Thoracic Aneurysm
Valiant Stent Graft System

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases processed this record on November 27, 2015