Registry in Patients With Aorto-iliac or Iliac Aneurysms (PLIANTII)

JOTEC

Status: Active, not recruiting

Conditions: Vascular Aneurysm

Treatments: Device: Endovascular repair

Study type: Observational

Funder types: Industry

Identifiers

NCT03606083

PLIANTII

Details and patient eligibility

About

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.

Full 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.

Enrollment: 298 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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