Vascular Aneurysm
Conditions
Keywords
aorto-iliac, iliac, aneurysm
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.
Interventions
DEVICEEndovascular repair
Endovascular repair of aorto-iliac or iliac aneurysms using an iliac branch device (IBD)
Sponsors
JOTEC GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Mortality | 24 hours | Rate of all cause mortality in peri-operative periods |
| 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) |
| 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 |
Countries
Germany
Outcome results
None listed