Valor II: The Valiant Thoracic Stent Graft System Clinical Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00413231
First received: December 15, 2006
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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
Estimated Study Completion Date: October 2014
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

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

Inclusion:

  • 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.

Exclusion:

  • 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 ClinicalTrials.gov identifier: NCT00413231

  Show 26 Study Locations
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Principal Investigator: Ronald Fairman, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov 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 3, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on August 26, 2014