Clinical Trial: Prospective Multicenter Study for the Endovascular Treatment of Iliac Aneurysm With the Branched E-liac Stent Graft
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Prospective Multicenter Study for the Endovascular Treatment of Iliac Aneurysm With the Branched E-liac Stent Graft
Brief Summary:
In this study, patients will be observed who receive an E-liac Stent Graft for treatment of isolated iliac aneurysms or an E-liac Stent Graft in combination with an E-tegra Stent Graft for treatment of aorto-iliac aneurysms.
Objectives of this post-market registry are:
Primary: To prevent the risk of rupture and death by the treatment of common iliac aneurysm with an iliac branched stent graft (E-liac, JOTEC) Secondary: Evaluation of safety and feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or bilateral aorto-iliac or iliac aneurysm.
Detailed Summary:
Sponsor: JOTEC GmbH
Current Primary Outcome: Clinical success [ Time Frame: 30 days follow-up ]
Clinical success related to the E-liac Stent Graft combines the following criteria (adapted from Chaikof 2002):
- Clinical success should be reported on an intent-to-treat Basis
- requires successful deployment of the E-liac Stent Graft at the intended location without
- Death as a result of iliac aneurysm-related treatment
- Type I or III endoleak
- E-liac Stent Graft infection
- E-liac Stent Graft thrombosis (including internal iliac artery thrombosis)
- Aneurysm growth >3mm in maximum diameter for common iliac aneurysm and >5mm in maximum diameter for aortic aneurysm at 12, 24, and 36 months follow-up
- Common iliac aneurysm rupture
- Conversion to open repair
- Failure of E-liac Stent Graft integrity
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: JOTEC GmbH
Dates:
Date Received: February 23, 2016
Date Started: April 2016
Date Completion: May 2021
Last Updated: June 3, 2016
Last Verified: April 2016
