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NCT Number: NCT03606083

Registry in Patients With 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, 50937, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

endovascular repair

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Mortality

    Time frame: 24 hours

    Rate of all cause mortality in peri-operative periods

  2. Survival rate

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

    Rate of survival

  3. Aneurysm size

    Time frame: 12, 24, 36, 60 months

    Rate of patients with decreasing, stable, increasing aneurysm size

  4. 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

  5. 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

  6. Stent graft dislodgement

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

    Rate of patients with stent graft dislodgement

  7. Endoleak type I

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

    Rate of patients with infrarenal type Ia endoleak

  8. 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

  9. 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

  10. 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

  11. 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

  12. Endoleak type II

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

    Rate of patients with endoleak type II

  13. Endoleak type III

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

    Rate of patients with endoleak type III

  14. Stent fracture

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

    Rate of patients with stent fracture

  15. Reintervention

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

    Rate patients with reintervention after E-liac Stent Graft implantation

  16. 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)

  17. 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)

Sponsors and collaborators

Lead sponsor

JOTEC GmbH

Industry

Registry information

Official study title

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

Acronym: PLIANTII

Important dates

Study start
2018
Primary completion
2028
Study completion
2029
First posted
Jul 30, 2018
Registry last updated
May 2, 2025

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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