NCT02209194

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
4 countries

12 active sites

Status
completed

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 Start

First participant enrolled

June 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

May 1, 2020

Status Verified

April 1, 2020

Enrollment Period

5.3 years

First QC Date

July 30, 2014

Last Update Submit

April 29, 2020

Conditions

Iliac Aneurysm

Keywords

aneurysmsvascular diseaseE-liac Stent GraftE-liac Stent Graft Systemiliac aneurysmbranched stent graftself expanding stent graft

Outcome Measures

Primary Outcomes (6)

  • Primary patency

    Primary patency of the arteria iliaca interna and the arteria iliaca externa on E-liac implantation side

    within 30 days

  • Primary Patency

    12 months

  • Primary patency

    36 months

  • Endoleak Type I or III

    within 30 days

  • Endoleak Type I or III

    12 months

  • Endoleak Type I or III

    36 months

Secondary Outcomes (7)

  • Change in aneurysm size

    within 30 days (baseline) and 36 months

  • Stent graft migration

    within 30 days (baseline) and 36 months

  • Stent graft dislodgement

    36 months

  • Stent graft kinking

    36 months

  • Distal embolization

    36 months

  • +2 more secondary outcomes

Study Arms (1)

Aortoiliac Aneurysms Iliac Aneurysms

Endovascular repair of aortoiliac or iliac aneurysms

Device: E-liac Stent Graft System

Interventions

E-liac Stent Graft SystemDEVICE

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

Aortoiliac Aneurysms Iliac Aneurysms

Eligibility Criteria

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

Patients with uni- or bilateral aortoiliac or common iliac aneurysm

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Herzzentrum Hietzing

Vienna, 1130, Austria

Location

Wilhelminenspital

Vienna, 1160, Austria

Location

German Heart Center

Berlin, 13353, Germany

Location

Klinikum Chemnitz

Chemnitz, 09113, Germany

Location

Cologne University Hospital

Cologne, 50937, Germany

Location

Uniklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

UKSH Campus Kiel

Kiel, 24105, Germany

Location

Krankenhaus Leonberg

Leonberg, 71229, Germany

Location

Marienhospital

Osnabrück, 49074, Germany

Location

Instytut Hematologii i Transfuzjologii

Warsaw, 02-776, Poland

Location

Hospital Universitario Donostia

Donostia / San Sebastian, 20080, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

Location

Related Publications (4)

  • Brunkwall JS, Vaquero-Puerta C, Heckenkamp J, Egana Barrenechea JM, Szopinski P, Mertikian G, Seifert S, Rumenapf G, Buz S, Assadian A, Majd P, Mylonas S, Calavia AR, Theis T, de Blas Bravo M, Pleban E, Schupp J, Esche M, Kocaer C, Hirsch K, Oberhuber A, Schafer JP. Prospective Study of the Iliac Branch Device E-liac in Patients with Common Iliac Artery Aneurysms: 12 Month Results. Eur J Vasc Endovasc Surg. 2019 Dec;58(6):831-838. doi: 10.1016/j.ejvs.2019.06.020. Epub 2019 Oct 12.

    PMID: 31615695BACKGROUND

  • Brunkwall J, Vaquero Puerta C, Heckenkamp J, Egana Barrenechea JM, Szopinski P, Mertikian G, Seifert S, Rumenapf G, Buz S, Assadian A, Majd P, Mylonas S, Revilla Calavia A, Theis T, de Blas Bravo M, Pleban E, Schupp J, Esche M, Kocaer C, Hirsch K, Oberhuber A, Schafer JP. Prospective study of the E-liac Stent Graft System in patients with common iliac artery aneurysms: 30-Day results. Vascular. 2018 Dec;26(6):647-656. doi: 10.1177/1708538118789510. Epub 2018 Jul 23.

    PMID: 30037302BACKGROUND

  • 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

MeSH Terms

Conditions

Iliac AneurysmAneurysmVascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Jan Brunkwall, Professor

    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

July 30, 2014

First Posted

August 5, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

May 1, 2020

Record last verified: 2020-04

Locations

PL(1)AU(2)ES(2)DE(7)