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

May 18, 2022 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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

400

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

    • NRW
      • Köln, NRW, Germany, 50937
        • Recruiting
        • Universitätsklinikum Köln
        • Contact:

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 to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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

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

Investigators

  • 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.

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)

July 15, 2018

Primary Completion (Anticipated)

September 30, 2024

Study Completion (Anticipated)

October 31, 2029

Study Registration Dates

First Submitted

June 29, 2018

First Submitted That Met QC Criteria

July 27, 2018

First Posted (Actual)

July 30, 2018

Study Record Updates

Last Update Posted (Actual)

May 19, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID 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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