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

April 29, 2020 updated by: JOTEC GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1160
        • Wilhelminenspital
      • Wien, Austria, 1130
        • Herzzentrum Hietzing
  • Germany
      • Berlin, Germany, 13353
        • German Heart Center
      • Chemnitz, Germany, 09113
        • Klinikum Chemnitz
      • Cologne, Germany, 50937
        • Cologne University Hospital
      • Düsseldorf, Germany, 40225
        • Uniklinikum Düsseldorf
      • Kiel, Germany, 24105
        • UKSH Campus Kiel
      • Leonberg, Germany, 71229
        • Krankenhaus Leonberg
      • Osnabrück, Germany, 49074
        • Marienhospital
  • Poland
      • Warszawa, Poland, 02-776
        • Instytut Hematologii i Transfuzjologii
  • Spain
      • San Sebastian, Spain, 20080
        • Hospital Universitario Donostia
      • Valladolid, Spain, 47003
        • Hospital Clínico Universitario de Valladolid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with uni- or bilateral aortoiliac or common iliac aneurysm

Description

Inclusion Criteria:

  • Patients must comply with the indications for use
  • Unilateral or bilateral common iliac aneurysm diameter equal or greater 25mm
  • Unsuitable distal sealing site within the common iliac artery for traditional EVAR

Exclusion Criteria:

  • Patients with a stenotic internal iliac ostium of < 4mm in diameter
  • Patients with severe internal iliac atherosclerosis
  • Patients that do not have a suitable landing area in the main stem of the IIA
  • Patients with pseudoaneurysms
  • Patients with symptomatic and ruptured iliac aneurysms
  • Patients with one of the contraindications as indicated in the instructions for use
  • Patients pretreated with a bifurcated vascular graft
  • Patient with thrombocytopenia
  • Patient with creatinine >2.4 mg/dl immediately before the intervention
  • Patient with malignancy needing chemotherapy or radiation
  • Patients who are enrolled in another clinical study
  • Patients with life expectancy of less than 36 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Aortoiliac Aneurysms Iliac Aneurysms
Endovascular repair of aortoiliac or iliac aneurysms
Device: E-liac Stent Graft System
Implantation of the E-liac Stent Graft System in combination with a peripheral covered stent and in case of aortoiliac aneurysm in combination with a AAA Stent Graft

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JOTEC GmbH

Investigators

  • Principal Investigator: Jan Brunkwall, Professor, Cologne University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ACTUAL)

September 1, 2019

Study Completion (ACTUAL)

September 1, 2019

Study Registration Dates

First Submitted

July 30, 2014

First Submitted That Met QC Criteria

August 1, 2014

First Posted (ESTIMATE)

August 5, 2014

Study Record Updates

Last Update Posted (ACTUAL)

May 1, 2020

Last Update Submitted That Met QC Criteria

April 29, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLIANT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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