Clinical Trial: Post-market Registry in Patients With Iliac Aneurysm Undergoing Endovascular Stenting With the E-liac Stent Graft System

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: PLIANT - A Post-market Registry in Patients With Iliac Aneurysm Undergoing Endovascular Stenting With a New Generation of Low Profile E-liac Stent Graft System

Brief Summary: The purpose of the study is to evaluate the clinical and technical success as well as safety and feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or bilateral aortoiliac or iliac aneurysm. Main study target is the exclusion of aneurysm with primary patency of the arteria iliaca interna and the arteria iliaca externa on iliac implantation side.

Detailed Summary:
Sponsor: JOTEC GmbH

Current Primary Outcome:

  • Primary patency [ Time Frame: within 30 days ]
    Primary patency of the arteria iliaca interna and the arteria iliaca externa on E-liac implantation side
  • Primary Patency [ Time Frame: 12 months ]
  • Primary patency [ Time Frame: 36 months ]
  • Endoleak Type I or III [ Time Frame: within 30 days ]
  • Endoleak Type I or III [ Time Frame: 12 months ]
  • Endoleak Type I or III [ Time Frame: 36 months ]


Original Primary Outcome:

  • Primary patency [ Time Frame: 36 months ]
    Primary patency of the arteria iliaca interna and the arteria iliaca externa on E-liac implantation side
  • Endoleak Type I or III [ Time Frame: 36 months ]
  • Primary patency [ Time Frame: within 30 days ]
    Primary patency of the arteria iliaca interna and arteria iliaca externa on E-liac implantation side.
  • Endoleak Type I or III [ Time Frame: within 30 days ]
  • Primary Patency [ Time Frame: 12 months ]
    Primary patency of the arteria iliaca interna and the arteria iliaca externa on E-liac implantation side
  • Endoleak Type I or III [ Time Frame: 12 months ]


Current Secondary Outcome:

  • Change in aneurysm size [ Time Frame: within 30 days (baseline) and 36 months ]
  • Stent graft migration [ Time Frame: within 30 days (baseline) and 36 months ]
  • Stent graft dislodgement [ Time Frame: 36 months ]
  • Stent graft kinking [ Time Frame: 36 months ]
  • Distal embolization [ Time Frame: 36 months ]
  • Rate of death [ Time Frame: 36 months ]
  • Rate of complications [ Time Frame: 36 months ]


Original Secondary Outcome: Same as current

Information By: JOTEC GmbH

Dates:
Date Received: July 30, 2014
Date Started: June 2014
Date Completion: July 2019
Last Updated: July 7, 2016
Last Verified: June 2016