Valor II: The Valiant Thoracic Stent Graft System Clinical Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00413231
First received: December 15, 2006
Last updated: November 25, 2015
Last verified: October 2015
  Purpose
This study was designed to study safety and effectiveness of the Valiant Thoracic Stent Graft to treat thoracic aortic aneurysms.

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:
  • Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint) [ Time Frame: 0 through 1825 days post treatment ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint) [ 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).


  • Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > > [ 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, 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.



Secondary Outcome Measures:
  • Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant [ Time Frame: At implant ] [ Designated as safety issue: No ]
    Percentage of subjects that experienced successful deployment and delivery of the stent graft at implant. Successful deployment and delivery of the stent graft is used to measure effectiveness.

  • Percentage of Participants That Experienced Perioperative Mortality [ Time Frame: Within 30 days post treatment ] [ Designated as safety issue: Yes ]
    Percentage of subjects that experienced perioperative mortality. Perioperative morality is defined as all-cause mortality within 30 days after index procedure.

  • Percentage of Participants That Experienced Paraplegia [ Time Frame: Within 30 days post treatment ] [ Designated as safety issue: Yes ]
    Percentage of subjects that experienced paraplegia within 30 days post treatment

  • Percentage of Participants That Experienced Paraparesis [ Time Frame: Within 30 days post treatment ] [ Designated as safety issue: Yes ]
    Percentage of subjects that experienced paraparesis within 30 days post treatment

  • Percentage of Participants That Experienced Secondary Procedures Due to Endoleak After Discharge [ Time Frame: Within 30 days post treatment ] [ Designated as safety issue: Yes ]
    Percentage of subjects that experienced secondary procedures due to endoleak after discharge within 30 days post treatment

  • Percentage of Participants That Experienced One or More Major Adverse Events [ Time Frame: Within 30 days post treatment ] [ Designated as safety issue: Yes ]
    Percentage of subjects that experienced one or more major adverse events within 30 days post treatment, regardless of relatedness to study device

  • Percentage of Participants That Experienced Aneurysm-related Mortality [ Time Frame: Within 12 months post treatment ] [ Designated as safety issue: Yes ]
    Percentage of subjects that experienced aneurysm-related mortality within 12 months post treatment

  • Percentage of Participants That Experience Aneurysm Rupture [ Time Frame: Within 12 months post treatment ] [ Designated as safety issue: Yes ]
    Percentage of subjects that experience aneurysm rupture within 12 months post treatment

  • Percentage of Participants That Experienced Conversion to Open Surgical Repair [ Time Frame: Within 12 months post treatment ] [ Designated as safety issue: Yes ]
    Percentage of subjects that experienced conversion to open surgical repair within 12 months post treatment

  • Percentage of Participants That Experienced Endoleak(s) [ Time Frame: At 12 months ] [ Designated as safety issue: Yes ]
    Percentage of subjects that experienced endoleak(s) of any type at 12 months

  • Percentage of Participants That Experienced Secondary Endovascular Procedures Due to Endoleak [ Time Frame: Between 30 days and 12 months ] [ Designated as safety issue: Yes ]
    Percentage of subjects that experienced secondary endovascular procedures due to endoleak between 30 days and 12 months

  • Percentage of Participants That Experienced Stent Graft Migration [ Time Frame: Within 12 months post treatment ] [ Designated as safety issue: Yes ]
    Percentage of subjects that experienced stent graft migration within 12 months post treatment, as reported by the CEC. Of note, all migrations resulted from anatomical accommodation of the stent graft. All migrations were at the distal end of the stent graft, moving proximally. No endoleaks were associated to these migrations.

  • Percentage of Participants That Experience Loss of Stent Graft Patency [ Time Frame: Within 12 months post treatment ] [ Designated as safety issue: Yes ]
    Percentage of subjects that experience loss of stent graft patency within 12 months post treatment

  • Percentage of Participants That Experienced One or More Major Adverse Events [ Time Frame: Within 12 months post treatment ] [ Designated as safety issue: Yes ]
    Percentage of subjects that experienced one or more Major Adverse Events within 12 months post treatment

  • Percentage of Participants That Died (All-cause Mortality) [ Time Frame: 0 through 1825 days post treatment ] [ Designated as safety issue: Yes ]
    Percentage of subjects that died (all-cause mortality) five years post implant, regardless whether or not the cause of death was related to procedure, device, or condition treated

  • Percentage of Participants That Experienced Aneurysm-related Mortality [ Time Frame: 0 through 1825 days post treatment ] [ Designated as safety issue: Yes ]
    Percentage of subjects that experienced aneurysm-related within five years post implant

  • Percentage of Participants That Experienced Aneurysm Ruptures [ Time Frame: 0 through 1825 days post treatment ] [ Designated as safety issue: Yes ]
    Percentage of subjects that experienced aneurysm ruptures within five years post implant

  • Percentage of Participants That Experienced Conversions to Open Surgical Repair [ Time Frame: 0 through 1825 days post treatment ] [ Designated as safety issue: Yes ]
    Percentage of subjects that experienced conversions to open surgical repair within five years post implant

  • Percentage of Participants That Experienced Type I Endoleaks [ Time Frame: 0 through 1825 days post treatment ] [ Designated as safety issue: Yes ]
    Percentage of subjects that experienced type I endoleaks within five years post implant

  • Percentage of Participants That Experienced Type III Endoleaks [ Time Frame: 0 through 1825 days post treatment ] [ Designated as safety issue: Yes ]
    Percentage of subjects that experienced type III endoleaks within five years post implant

  • Percentage of Participants That Experienced Type IV Endoleaks [ Time Frame: 0 through 1825 days post treatment ] [ Designated as safety issue: Yes ]
    Percentage of subjects that experienced type IV endoleaks within five years post implant

  • Percentage of Participants That Experienced Secondary Endovascular Procedures [ Time Frame: 0 through 1825 days post treatment ] [ Designated as safety issue: Yes ]
    Percentage of subjects that experienced secondary endovascular procedures within five years post implant

  • Percentage of Participants That Experienced Stent Graft Migrations (Site Reported) [ Time Frame: 0 through 1825 days post treatment ] [ Designated as safety issue: Yes ]
    Percentage of subjects that experienced stent graft migrations within five years post implant, as reported by the clinical sites

  • Percentage of Participants That Experienced Loss of Stent Graft Patency [ Time Frame: 0 through 1825 days post treatment ] [ Designated as safety issue: Yes ]
    Percentage of subjects that experienced loss of stent graft patency within five years post implant


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.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

The following inclusion/exclusion criteria was obtained from the study protocol.

INCLUSION CRITERIA

To be eligible for enrollment, a subject must meet all of the following inclusion criteria:

  1. Subject is between the age of 18 and 85.
  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

To be eligible for enrollment, a subject cannot meet any of the following exclusion criteria:

  1. Planned placement of the COVERED portion of the stent graft requires implant to occur in zones 0 or 1.
  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.
  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

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: November 25, 2015
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 July 24, 2016