NCT03606083

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
298

participants targeted

Target at P75+ for all trials

Timeline
43mo left

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Jul 2018Oct 2029

First Submitted

Initial submission to the registry

June 29, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

July 15, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2029

Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

10.2 years

First QC Date

June 29, 2018

Last Update Submit

April 29, 2025

Conditions

Vascular Aneurysm

Keywords

aorto-iliaciliacaneurysm

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Secondary Outcomes (17)

  • Mortality

    24 hours

  • Survival rate

    prior to discharge / 30 days, 12, 24, 36, 60 months

  • Aneurysm size

    12, 24, 36, 60 months

  • Primary patency of EIA / IIA

    prior to discharge / 30 days, 12, 24, 36, 60 months

  • Secondary patency of EIA / IIA

    prior to discharge / 30 days, 12, 24, 36, 60 months

  • +12 more secondary outcomes

Interventions

Endovascular repairDEVICE

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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Related Publications (3)

  • Anton S, Wiedner M, Stahlberg E, Jacob F, Barkhausen J, Goltz JP. Initial Experience with the E-liac(R) Iliac Branch Device for the Endovascular Aortic Repair of Aorto-iliac Aneurysm. Cardiovasc Intervent Radiol. 2018 May;41(5):683-691. doi: 10.1007/s00270-017-1868-x. Epub 2018 Jan 3.

    PMID: 29299625BACKGROUND

  • Mylonas SN, Rumenapf G, Schelzig H, Heckenkamp J, Youssef M, Schafer JP, Ahmad W, Brunkwall JS; E-liac Collaborative Group. A multicenter 12-month experience with a new iliac side-branched device for revascularization of hypogastric arteries. J Vasc Surg. 2016 Dec;64(6):1652-1659.e1. doi: 10.1016/j.jvs.2016.04.065. Epub 2016 Aug 1.

    PMID: 27492764BACKGROUND

  • Oberhuber A, Deglise S, Richter O, Makaloski V, Bracale U, Isernia G, Tines R, Cappelli A, Dorweiler B, Brunkwall J; PLIANTII Study Collaboration. A Prospective, Multicentre Registry on Thirty Day and One Year Outcomes of the E-liac Stent Graft System in Patients with Unilateral or Bilateral Aorto-iliac or Iliac Aneurysms: The PLIANTII Study. Eur J Vasc Endovasc Surg. 2025 Jun;69(6):847-854. doi: 10.1016/j.ejvs.2025.02.029. Epub 2025 Feb 20.

    PMID: 39986435RESULT

MeSH Terms

Conditions

Aneurysm

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeBlood Vessel Prosthesis ImplantationVascular GraftingMinimally Invasive Surgical ProceduresProsthesis Implantation

Study Officials

  • Jan Brunkwall, Prof.

    Cologne University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2018

First Posted

July 30, 2018

Study Start

July 15, 2018

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

October 31, 2029

Last Updated

May 2, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)