Registry in Patients With Aorto-iliac or Iliac Aneurysms (NCT03606083) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Registry in Patients With Aorto-iliac or Iliac Aneurysms
Germany298 participantsStarted 2018-07-15
Plain-language summary
The PLIANT II registry is undertaken to examine the real-world outcome after treatment of consecutive patients with uni- or bilateral aorto-iliac or iliac aneurysms using the E-liac Stent Graft System.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
* Age between 18 and 85 years
* Patient must have an aorto-iliac or iliac aneurysm
* Patient must have a unilateral or bilateral iliac aneurysm
* Patient´s anatomy must be suitable for stent graft placement on preoperative angio CT scan
* Patient must be available for the appropriate follow-up times for the duration of the study
* Patient has been informed of the nature of the study, agrees to its provisions and has signed the informed consent form prior to intervention
Exclusion Criteria:
* Female of child bearing potential
* Patients with ruptured iliac aneurysms
* Patients with juxtarenal, pararenal or suprarenal aneurysms
* Patients pretreated with Nellix (Endologix) or Altura (Lombard Medical)
* Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
* Patient with malignancy needing chemotherapy or radiation
* Patients with life expectancy of less than 3 years
* Patient minor or under guardianship
What they're measuring
1
Freedom from endoleak type I or III and patency of EIA and IIA on E-liac implantation side(s)