Registry in Patients With Aorto-iliac or Iliac Aneurysms

N/AActive Not RecruitingNCT03606083

JOTEC GmbH298 enrolled

Overview

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.

In this study, patients will be observed who receive one or two E-liac Stent Graft(s) for aorto-iliac or iliac aneurysms. The E-liac Stent Graft(s) will be implanted at the discretion of the treating physician. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the E-liac Stent Graft System. Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before intervention and before data are being collected. The period of data collection will be 60 months starting from the intervention for each patient. 100% verification of patient informed consent and essential study documents will be performed at each study site. 60% of patient´s source documentation will be randomly monitored.

Study Type

OBSERVATIONAL

Enrollment

298

Conditions

Vascular Aneurysm

Interventions

Endovascular repairDEVICE

Endovascular repair of aorto-iliac or iliac aneurysms using an iliac branch device (IBD)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

Freedom from endoleak type I or III and patency of EIA and IIA on E-liac implantation side(s)

Rate of patients that reach the primary endpoint

Time frame: 12 months

Secondary Outcomes

Mortality

Rate of all cause mortality in peri-operative periods

Time frame: 24 hours

Survival rate

Rate of survival