Registry in Patients With Aorto-iliac or Iliac Aneurysms (PLIANTII)

April 29, 2025 updated by: JOTEC GmbH

Prospective Multicenter Registry to Examine the Real-world Performance of the E-liac Stent Graft System for Treatment of Uni- or Bilateral Aorto-iliac or Iliac Aneurysms

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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.

Detailed Description

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

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.
298

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

  • Germany
    • NRW
      • Köln, NRW, Germany, 50937
        • Universitatsklinikum Koln

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Male and female patients with uni- or bilateral aorto-iliac or iliac aneurysm, treated with the E-liac Stent Graft System.

Description

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

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

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
Freedom from endoleak type I or III and patency of EIA and IIA on E-liac implantation side(s)
Time Frame: 12 months
Rate of patients that reach the primary endpoint
12 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
Measure Description
Time Frame
Mortality
Time Frame: 24 hours
Rate of all cause mortality in peri-operative periods
24 hours
Survival rate
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of survival
prior to discharge / 30 days, 12, 24, 36, 60 months
Aneurysm size
Time Frame: 12, 24, 36, 60 months
Rate of patients with decreasing, stable, increasing aneurysm size
12, 24, 36, 60 months
Primary patency of EIA / IIA
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with primary patency of EIA / IIA
prior to discharge / 30 days, 12, 24, 36, 60 months
Secondary patency of EIA / IIA
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with secondary patency of EIA / IIA
prior to discharge / 30 days, 12, 24, 36, 60 months
Stent graft dislodgement
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with stent graft dislodgement
prior to discharge / 30 days, 12, 24, 36, 60 months
Endoleak type I
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with infrarenal type Ia endoleak
prior to discharge / 30 days, 12, 24, 36, 60 months
Endoleak type Ia in the CIA (isolated iliac aneurysm treatment)
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with infrarenal type Ia endoleak
prior to discharge / 30 days, 12, 24, 36, 60 months
Endoleak type Ib in the CIA
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with endoleak type Ib in the CIA
prior to discharge / 30 days, 12, 24, 36, 60 months
Endoleak type Ib in the EIA
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with endoleak type Ib in the EIA
prior to discharge / 30 days, 12, 24, 36, 60 months
Endoleak type Ib in the IIA
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with endoleak type Ib in the IIA
prior to discharge / 30 days, 12, 24, 36, 60 months
Endoleak type II
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with endoleak type II
prior to discharge / 30 days, 12, 24, 36, 60 months
Endoleak type III
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with endoleak type III
prior to discharge / 30 days, 12, 24, 36, 60 months
Stent fracture
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with stent fracture
prior to discharge / 30 days, 12, 24, 36, 60 months
Reintervention
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate patients with reintervention after E-liac Stent Graft implantation
prior to discharge / 30 days, 12, 24, 36, 60 months
Claudication
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with increasing, stable, decreasing claudication (walking distance without pain)
prior to discharge / 30 days, 12, 24, 36, 60 months
Adverse Events
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with adverse events (product-related, procedure-related, aneurysm-related)
prior to discharge / 30 days, 12, 24, 36, 60 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, Prof., 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 (Actual)

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.
July 15, 2018

Primary Completion (Estimated)

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 30, 2028

Study Completion (Estimated)

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.
October 31, 2029

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).
June 29, 2018

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.
July 27, 2018

First Posted (Actual)

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.
July 30, 2018

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 2, 2025

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, 2025

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, 2025

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.
  • PLIANTII

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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