Clinical trial NCT03606083: Registry in Patients With Aorto-iliac or Iliac Aneurysms
Official 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Vascular Aneurysm
Keywords: aorto-iliac
iliac
aneurysm
Lead sponsor: JOTEC GmbH
Sponsor class: INDUSTRY
First posted: 2018-07-30
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female patients with uni- or bilateral aorto-iliac or iliac aneurysm, treated with the E-liac Stent Graft System.

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Freedom from endoleak type I or III and patency of EIA and IIA on E-liac implantation side(s)
timeFrame: 12 months
Secondary outcomes:
measure: Mortality
timeFrame: 24 hours
measure: Survival rate
timeFrame: prior to discharge / 30 days, 12, 24, 36, 60 months
measure: Aneurysm size
timeFrame: 12, 24, 36, 60 months
measure: Primary patency of EIA / IIA
timeFrame: prior to discharge / 30 days, 12, 24, 36, 60 months
measure: Secondary patency of EIA / IIA
timeFrame: prior to discharge / 30 days, 12, 24, 36, 60 months
measure: Stent graft dislodgement
timeFrame: prior to discharge / 30 days, 12, 24, 36, 60 months
measure: Endoleak type I
timeFrame: prior to discharge / 30 days, 12, 24, 36, 60 months
measure: Endoleak type Ia in the CIA (isolated iliac aneurysm treatment)
timeFrame: prior to discharge / 30 days, 12, 24, 36, 60 months
measure: Endoleak type Ib in the CIA
timeFrame: prior to discharge / 30 days, 12, 24, 36, 60 months
measure: Endoleak type Ib in the EIA
timeFrame: prior to discharge / 30 days, 12, 24, 36, 60 months
measure: Endoleak type Ib in the IIA
timeFrame: prior to discharge / 30 days, 12, 24, 36, 60 months
measure: Endoleak type II
timeFrame: prior to discharge / 30 days, 12, 24, 36, 60 months
measure: Endoleak type III
timeFrame: prior to discharge / 30 days, 12, 24, 36, 60 months
measure: Stent fracture
timeFrame: prior to discharge / 30 days, 12, 24, 36, 60 months
measure: Reintervention
timeFrame: prior to discharge / 30 days, 12, 24, 36, 60 months
measure: Claudication
timeFrame: prior to discharge / 30 days, 12, 24, 36, 60 months
measure: Adverse Events
timeFrame: prior to discharge / 30 days, 12, 24, 36, 60 months
Other outcomes:
Locations:
city: Köln
country: Germany
facility: Universitätsklinikum Köln
state: NRW
Study officials:
affiliation: Cologne University Hospital
name: Jan Brunkwall, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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 Feb 20:S1078-5884(25)00163-7. doi: 10.1016/j.ejvs.2025.02.029. Online ahead of print.