Registry in Patients With Aorto-iliac or Iliac Aneurysms
- Conditions
- Vascular Aneurysm
- Registration Number
- NCT03606083
- Lead Sponsor
- JOTEC GmbH
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 298
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Secondary patency of EIA / IIA prior to discharge / 30 days, 12, 24, 36, 60 months Rate of patients with secondary patency of EIA / IIA
Endoleak type III prior to discharge / 30 days, 12, 24, 36, 60 months Rate of patients with endoleak type III
Claudication prior to discharge / 30 days, 12, 24, 36, 60 months Rate of patients with increasing, stable, decreasing claudication (walking distance without pain)
Endoleak type I prior to discharge / 30 days, 12, 24, 36, 60 months Rate of patients with infrarenal type Ia endoleak
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
Adverse Events prior to discharge / 30 days, 12, 24, 36, 60 months Rate of patients with adverse events (product-related, procedure-related, aneurysm-related)
Stent graft dislodgement prior to discharge / 30 days, 12, 24, 36, 60 months Rate of patients with stent graft dislodgement
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 II prior to discharge / 30 days, 12, 24, 36, 60 months Rate of patients with endoleak type II
Reintervention prior to discharge / 30 days, 12, 24, 36, 60 months Rate patients with reintervention after E-liac Stent Graft implantation
Stent fracture prior to discharge / 30 days, 12, 24, 36, 60 months Rate of patients with stent fracture
Trial Locations
- Locations (1)
Universitätsklinikum Köln
🇩🇪Köln, NRW, Germany