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Completed

NCT Number: NCT02209194

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

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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Key information

Conditions

Iliac Aneurysm Aneurysm Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herzzentrum Hietzing, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

E-liac Stent Graft System

Device

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

Primary outcomes

  1. Primary patency

    Time frame: within 30 days

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

  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

Sponsors and collaborators

Lead sponsor

JOTEC GmbH

Industry

Registry information

Official study title

PLIANT - A Post-market Registry in Patients With Iliac Aneurysm Undergoing Endovascular Stenting With a New Generation of Low Profile E-liac Stent Graft System

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Aug 5, 2014
Registry last updated
May 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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