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CompletedNCT02209194Updated May 1, 2020

Post-market Registry in Patients With Iliac Aneurysm Undergoing Endovascular Stenting With the E-liac Stent Graft System

An observational study in Iliac Aneurysm, sponsored by JOTEC GmbH. Completed at 12 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-01.

Sponsored by JOTEC GmbH · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
47
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Iliac Aneurysm

Keywords

  • aneurysms
  • vascular disease
  • E-liac Stent Graft
  • E-liac Stent Graft System
  • iliac aneurysm
  • branched stent graft
  • self expanding stent graft
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In context

Aneurysm

959 studies on the registry are indexed under Aneurysm; 174 are open to participants now.

This study's enrollment of 47 is below the median of 151 across 443 observational studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

JOTEC GmbH is the lead sponsor of 20 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with uni- or bilateral aortoiliac or common iliac aneurysm

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
47 participants (actual)
Patient registry
No

Groups and cohorts

  • Aortoiliac Aneurysms Iliac Aneurysms

    Endovascular repair of aortoiliac or iliac aneurysms

    Device: E-liac Stent Graft System

Interventions

  • DeviceE-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

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What researchers measure

Primary outcomes

  1. Primary patency

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

    Time frame: within 30 days

  2. Primary Patency

    Time frame: 12 months

  3. Primary patency

    Time frame: 36 months

  4. Endoleak Type I or III

    Time frame: within 30 days

  5. Endoleak Type I or III

    Time frame: 12 months

  6. Endoleak Type I or III

    Time frame: 36 months

Secondary outcomes

  1. Change in aneurysm size

    Time frame: within 30 days (baseline) and 36 months

  2. Stent graft migration

    Time frame: within 30 days (baseline) and 36 months

  3. Stent graft dislodgement

    Time frame: 36 months

  4. Stent graft kinking

    Time frame: 36 months

  5. Distal embolization

    Time frame: 36 months

  6. Rate of death

    Time frame: 36 months

  7. Rate of complications

    Time frame: 36 months

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Study locations

12 sites
  • Herzzentrum Hietzing
    Wien, 1130, Austria
  • Wilhelminenspital
    Wien, 1160, Austria
  • German Heart Center
    Berlin, 13353, Germany
  • Klinikum Chemnitz
    Chemnitz, 09113, Germany
  • Cologne University Hospital
    Cologne, 50937, Germany
  • Uniklinikum Düsseldorf
    Düsseldorf, 40225, Germany
  • UKSH Campus Kiel
    Kiel, 24105, Germany
  • Krankenhaus Leonberg
    Leonberg, 71229, Germany
  • Marienhospital
    Osnabrück, 49074, Germany
  • Instytut Hematologii i Transfuzjologii
    Warszawa, 02-776, Poland
  • Hospital Universitario Donostia
    San Sebastian, 20080, Spain
  • Hospital Clínico Universitario de Valladolid
    Valladolid, 47003, Spain
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References and documents

Publications

  • 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. PubMed 31615695 ↗
  • 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. PubMed 30037302 ↗
  • 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. PubMed 29299625 ↗
  • 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. PubMed 27492764 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02209194
Lead sponsor
JOTEC GmbH
Responsible party
Sponsor
First posted
Aug 5, 2014
Start date
Jun 2014
Primary completion
Sep 2019
Completion
Sep 2019
Last update
May 1, 2020

Study contacts

Jan Brunkwall, Professor
principal investigator · Cologne University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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