NCT00543270

Brief Summary

Endologix Infrarenal Bifurcated Stent Graft Study

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

October 5, 2021

Status Verified

September 1, 2021

Enrollment Period

4.1 years

First QC Date

October 10, 2007

Last Update Submit

September 30, 2021

Conditions

Abdominal Aortic Aneurysm

Keywords

EVARAAAAneurysmPowerlink

Outcome Measures

Primary Outcomes (2)

  • No of Subjects with Major adverse events

    Aneurysm-related mortality, aneurysm rupture, conversion to open repair, coronary intervention, myocardial infarction, renal failure, respiratory failure, secondary procedure, and stroke

    At 1 Year

  • All Cause Mortality

    No of deaths reported through 1 year

    At 1 Year

Secondary Outcomes (17)

  • Stent Graft Performance

    30 Days

  • Stent Graft Performance

    6 Months

  • Stent Graft Performance

    Year 1

  • Stent Graft Performance

    Year 2

  • Stent Graft Performance

    Year 3

  • +12 more secondary outcomes

Study Arms (2)

Endovascular Repair - EVAR (Powerlink System)

EXPERIMENTAL

EVAR (Powerlink System)

Device: Powerlink infrarenal bifurcated stent graft delivery system

Open Surgical Control

ACTIVE COMPARATOR

Open Surgical Control

Procedure: Open Surgery

Interventions

Powerlink infrarenal bifurcated stent graft delivery systemDEVICE

Endovascular abdominal aortic aneurysm repair

Also known as: Powerlink Stent Graft Delivery System
Endovascular Repair - EVAR (Powerlink System)
Open SurgeryPROCEDURE

Open surgical abdominal aortic aneurysm repair

Open Surgical Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Arizona Heart Institute

Phoenix, Arizona, 85006, United States

Location

Harbor-UCLA Medical Center

Torrance, California, 90506, United States

Location

University of Illinois School of Medicine

Peoria, Illinois, 61604, United States

Location

SIU School of Medicine

Springfield, Illinois, 62702, United States

Location

Mercy Hospital

Des Moines, Iowa, 50314, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Advanced Vascular Associates

Morristown, New Jersey, 07960, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, 73120, United States

Location

University Hospital of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

Heart Hospital of South Dakota

Sioux Falls, South Dakota, 57108, United States

Location

Vascular and Transplant Specialists

Norfolk, Virginia, 23510, United States

Location

Related Publications (4)

  • Carpenter JP. The Powerlink bifurcated system for endovascular aortic aneurysm repair: four-year results of the US multicenter trial. J Cardiovasc Surg (Torino). 2006 Jun;47(3):239-43.

    PMID: 16760859RESULT

  • Parmer SS, Carpenter JP; Endologix Investigators. Endovascular aneurysm repair with suprarenal vs infrarenal fixation: a study of renal effects. J Vasc Surg. 2006 Jan;43(1):19-25. doi: 10.1016/j.jvs.2005.09.025.

    PMID: 16414382RESULT

  • Wang GJ, Carpenter JP. EVAR in small versus large aneurysms: does size influence outcome? Vasc Endovascular Surg. 2009 Jun-Jul;43(3):244-51. doi: 10.1177/1538574408327570. Epub 2008 Dec 16.

    PMID: 19088132RESULT

  • Wang GJ, Carpenter JP; Endologix Investigators. The Powerlink system for endovascular abdominal aortic aneurysm repair: six-year results. J Vasc Surg. 2008 Sep;48(3):535-45. doi: 10.1016/j.jvs.2008.04.031. Epub 2008 Jul 16.

    PMID: 18635335RESULT

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalAneurysm

Interventions

Conversion to Open Surgery

Condition Hierarchy (Ancestors)

Aortic AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Intervention Hierarchy (Ancestors)

EndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Rodney White, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2007

First Posted

October 12, 2007

Study Start

October 1, 2005

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

October 5, 2021

Record last verified: 2021-09

Locations

US(14)