Powerlink Bifurcated Stent Graft Long-Term Follow-up Study

Endologix

Status: Completed

Conditions: Abdominal Aortic Aneurysm

Treatments: Procedure: Open Surgery; Device: Powerlink infrarenal bifurcated stent graft delivery system

Study type: Interventional

Funder types: Industry

Identifiers

NCT00543270

TP00-005/CP04-001

Details and patient eligibility

About

Endologix Infrarenal Bifurcated Stent Graft Study

Enrollment: 258 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• All surviving patients from the original study cohort who received the Powerlink device
• All surviving patients from the original study cohort who were assigned to the open surgical control arm

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

258 participants in 2 patient groups

Endovascular Repair - EVAR (Powerlink System)

Experimental group

Description:

EVAR (Powerlink System)

Treatment:

Device: Powerlink infrarenal bifurcated stent graft delivery system

Open Surgical Control

Active Comparator group

Description:

Open Surgical Control

Treatment:

Procedure: Open Surgery