Registry in Patients With Aorto-iliac or Iliac Aneurysms

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Vascular Aneurysm

Intervention / Treatment
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* Device: Endovascular repair


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Endovascular repair|Endovascular repair of aorto-iliac or iliac aneurysms using an iliac branch device (IBD)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from endoleak type I or III and patency of EIA and IIA on E-liac implantation side(s) | Rate of patients that reach the primary endpoint | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aorto-iliac, iliac, aneurysm