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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
JOTEC GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2014

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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