Powerlink Bifurcated Stent Graft Long-Term Follow-up Study

Not Applicable

Completed

• Conditions: Abdominal Aortic Aneurysm
• Interventions: Procedure: Open Surgery; Device: Powerlink infrarenal bifurcated stent graft delivery system

• Registration Number: NCT00543270
• Lead Sponsor: Endologix

Brief Summary

Endologix Infrarenal Bifurcated Stent Graft Study

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2007-10-10
• Study First Submitted QC: 2007-10-11
• Study First Posted: 2007-10-12
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-30
• Last Update Posted: 2021-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open Surgical Control	Open Surgery	Open Surgical Control
Endovascular Repair - EVAR (Powerlink System)	Powerlink infrarenal bifurcated stent graft delivery system	EVAR (Powerlink System)

Primary Outcome Measures

Name	Time	Method
All Cause Mortality	At 1 Year	No of deaths reported through 1 year
No of Subjects with Major adverse events	At 1 Year	Aneurysm-related mortality, aneurysm rupture, conversion to open repair, coronary intervention, myocardial infarction, renal failure, respiratory failure, secondary procedure, and stroke

Secondary Outcome Measures

Name	Time	Method
Stent Graft Performance	Year 5	Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Clinical Utility Outcomes	up to 1 week	Estimated Hospitalization Time
Aneurysm Morphology	Year 5	Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 5

Trial Locations

Locations (14)

Heart Hospital of South Dakota; 🇺🇸 Sioux Falls, South Dakota, United States

University of Illinois School of Medicine; 🇺🇸 Peoria, Illinois, United States

Advanced Vascular Associates; 🇺🇸 Morristown, New Jersey, United States

SIU School of Medicine; 🇺🇸 Springfield, Illinois, United States

Vascular and Transplant Specialists; 🇺🇸 Norfolk, Virginia, United States

Mercy Hospital; 🇺🇸 Des Moines, Iowa, United States

Greenville Hospital System; 🇺🇸 Greenville, South Carolina, United States

Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

University Hospital of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Barnes Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

Arizona Heart Institute; 🇺🇸 Phoenix, Arizona, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Oklahoma Cardiovascular Research Group; 🇺🇸 Oklahoma City, Oklahoma, United States