Clinical Trial: VALIANT CAPTIVIA Post-market Registry

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: VALIANT CAPTIVIA Post-market Registry A Multi-center, Post-market, Non Interventional, Prospective Study

Brief Summary:

The Valiant Thoracic Stent Graft has been preloaded on the new Captivia Delivery System (Captivia). This new delivery system was CE marked on September 14th, 2009 and was commercially released in the European Union on October 1st, 2009.

The Valiant Thoracic Stent Graft with the Captivia Delivery System (Valiant Captivia) is designed to treat diseases of the descending thoracic aorta including but not limited to aneurysms and dissections.

The purpose of the VALIANT CAPTIVIA Registry is to collect and evaluate mid term clinical performance data of the Valiant Captivia Thoracic Stent Graft System following OUS market approval.


Detailed Summary:

  1. Use of controls

    1. This study is a post-market registry without using a control. All analyses will be descriptive in nature and no statistical comparisons are planned.

      Sample size

    2. There is no sample size calculation since this is not a hypothesis driven study; VALIANT CAPTIVIA has recruited 100 subjects and will follow these subjects through for approximately 36 months.

  2. Number of investigation sites and study duration

    1. 15 investigation sites in Europe and Turkey where the Valiant Captivia Thoracic Stent Graft System is commercially available have enrolled 100 subjects.
    2. There will be no minimum nor maximum number of enrolled subjects per investigation site.
    3. The sites' compliance with the clinical investigation plan will be assessed on an ongoing basis. In case of serious non-compliance, the sponsor may decide to stop subject enrolment in a site based on the assessment.

Sponsor: Medtronic Endovascular

Current Primary Outcome:

  • Treatment Success [ Time Frame: at 30 days, 12 months, 24 months and 36 months ]

    technical success and freedom from

    • TAA diameter increase of stented segment (>5mm compared to 1 mo),
    • Types I/III endoleak,
    • Aneurysm rupture,
    • Conversion to open surgery,
    • Stent graft occlusion,
    • Stent graft migration resulting in SAE or secondary intervention.
  • Technical Success at Time of Initial Implant [ Time Frame: intraoperatively ]
    Technical success is defined as successful delivery and deployment of the stent graft (assessed intraoperatively). This is achieved by deployment of the Valiant Thoracic Stent Graft in the planned location with no unintentional coverage of the left subclavian artery, left common carotid artery and/or brachiocephalic artery and with the removal of the delivery system


Original Primary Outcome: Treatment Success [ Time Frame: at 12 months ]

technical success and freedom from

  • TAA diameter increase of stented segment (>5mm compared to 1 mo),
  • Types I/III endoleak,
  • Aneurysm rupture,
  • Conversion to open surgery,
  • Stent graft occlusion,
  • Stent graft migration resulting in SAE or secondary intervention.


Current Secondary Outcome:

  • SAE [ Time Frame: through 12 months ]
    Serious Adverse Events (SAE)
  • ACM and ARM [ Time Frame: at 30 days, 12 months, 24 months and 36 months ]
    All-cause (ACM), Aneurysm related (ARM) and dissection related mortality


Original Secondary Outcome:

  • Technical success [ Time Frame: 0 days (assessed intraoperatively). ]
    Successful delivery and deployment of the stent graft (assessed intraoperatively).
  • SADE, SAE or TO [ Time Frame: through 12 months ]
    (Serious) Adverse Device Effects (SADE) Technical Observations (TO) Serious Adverse Events (SAE)
  • ACM and ARM [ Time Frame: 12 mo ]
    All-cause (ACM), Aneurysm related (ARM) and dissection related mortality


Information By: Medtronic Endovascular

Dates:
Date Received: August 10, 2010
Date Started: February 2010
Date Completion:
Last Updated: January 22, 2015
Last Verified: January 2015