Clinical Trial: Valor II: The Valiant Thoracic Stent Graft System Clinical Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: This study was designed to study safety and effectiveness of the Valiant Thoracic Stent Graft to treat thoracic aortic aneurysms.

Detailed Summary: 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.
Sponsor: Medtronic Endovascular

Current Primary Outcome:

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

    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 ]

    The percentage of participants who died within 12-months of the initial procedure, whether or n

    Original Primary Outcome: Successful aneurysm treatment at 12 month follow-up is defined as the absence of both: Aneurysm growth > than 5 mm at the 12 month visit relative to the 1 month visit. Type I and Type III endoleak where a secondary procedure was performed or recommended.

    Current Secondary Outcome:

    • Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant [ Time Frame: At implant ]
      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 ]
      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 ]
      Percentage of subjects that experienced paraplegia within 30 days post treatment
    • Percentage of Participants That Experienced Paraparesis [ Time Frame: Within 30 days post treatment ]
      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 ]
      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 ]
      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 ]
      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 ]
      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 ]
      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 ]
      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 ]
      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 ]
      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 ]
      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 ]
      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 ]
      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 ]
      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 ]
      Percentage of subjects that experienced aneurysm ruptures within five years post implant
    • Will evaluate the percentage of patients that experience adverse events within 30 days and 12 months after treatment,successful implantation of the device and health care utilzation
    • The secondary endpoints will be evaluated all time points in the study will also be evaluated at all the follow-up intervals over 5 years.


    Information By: Medtronic Endovascular

    Dates:
    Date Received: December 15, 2006
    Date Started: December 2006
    Date Completion:
    Last Updated: November 25, 2015
    Last Verified: October 2015