NCT03606083

Registry in Patients With Aorto-iliac or Iliac Aneurysms

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 298 (actual)
• Sponsor: JOTEC GmbH · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vascular Aneurysm

Interventions

Type	Name	Description
DEVICE	Endovascular repair	Endovascular repair of aorto-iliac or iliac aneurysms using an iliac branch device (IBD)

Timeline

• Start date: 2018-07-15
• Primary completion: 2028-09-30
• Completion: 2029-10-31
• First posted: 2018-07-30
• Last updated: 2025-05-02

Locations

1 site across 1 country: Germany