Registry in Patients With Aorto-iliac or Iliac Aneurysms

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.

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

Primary outcomes

• Freedom from endoleak type I or III and patency of EIA and IIA on E-liac implantation side(s) [12 months]: Rate of patients that reach the primary endpoint

Secondary outcomes

• Mortality [24 hours]: Rate of all cause mortality in peri-operative periods
• Survival rate [prior to discharge / 30 days, 12, 24, 36, 60 months]: Rate of survival
• Aneurysm size [12, 24, 36, 60 months]: Rate of patients with decreasing, stable, increasing aneurysm size
• Primary patency of EIA / IIA [prior to discharge / 30 days, 12, 24, 36, 60 months]: Rate of patients with primary patency of EIA / IIA
• Secondary patency of EIA / IIA [prior to discharge / 30 days, 12, 24, 36, 60 months]: Rate of patients with secondary patency of EIA / IIA
• Stent graft dislodgement [prior to discharge / 30 days, 12, 24, 36, 60 months]: Rate of patients with stent graft dislodgement
• Endoleak type I [prior to discharge / 30 days, 12, 24, 36, 60 months]: Rate of patients with infrarenal type Ia endoleak
• Endoleak type Ia in the CIA (isolated iliac aneurysm treatment) [prior to discharge / 30 days, 12, 24, 36, 60 months]: Rate of patients with infrarenal type Ia endoleak
• Endoleak type Ib in the CIA [prior to discharge / 30 days, 12, 24, 36, 60 months]: Rate of patients with endoleak type Ib in the CIA
• Endoleak type Ib in the EIA [prior to discharge / 30 days, 12, 24, 36, 60 months]: Rate of patients with endoleak type Ib in the EIA
• Endoleak type Ib in the IIA [prior to discharge / 30 days, 12, 24, 36, 60 months]: Rate of patients with endoleak type Ib in the IIA
• Endoleak type II [prior to discharge / 30 days, 12, 24, 36, 60 months]: Rate of patients with endoleak type II
• Endoleak type III [prior to discharge / 30 days, 12, 24, 36, 60 months]: Rate of patients with endoleak type III
• Stent fracture [prior to discharge / 30 days, 12, 24, 36, 60 months]: Rate of patients with stent fracture
• Reintervention [prior to discharge / 30 days, 12, 24, 36, 60 months]: Rate patients with reintervention after E-liac Stent Graft implantation
• Claudication [prior to discharge / 30 days, 12, 24, 36, 60 months]: Rate of patients with increasing, stable, decreasing claudication (walking distance without pain)
• Adverse Events [prior to discharge / 30 days, 12, 24, 36, 60 months]: Rate of patients with adverse events (product-related, procedure-related, aneurysm-related)

Sex: All, ages: 18 Years to 85 Years

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

• 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 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. PMID 27492764
• Results publication: 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 Jun;69(6):847-854. doi: 10.1016/j.ejvs.2025.02.029. Epub 2025 Feb 20. PMID 39986435

• Jan Brunkwall, Prof., Principal investigator, Cologne University Hospital