Powerlink Bifurcated Stent Graft Long-Term Follow-up Study

NCT ID: NCT00543270

Last Updated: 2021-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2009-11-30

Brief Summary

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Endologix Infrarenal Bifurcated Stent Graft Study

Detailed Description

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Conditions

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Abdominal Aortic Aneurysm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endovascular Repair - EVAR (Powerlink System)

EVAR (Powerlink System)

Group Type EXPERIMENTAL

Powerlink infrarenal bifurcated stent graft delivery system

Intervention Type DEVICE

Endovascular abdominal aortic aneurysm repair

Open Surgical Control

Open Surgical Control

Group Type ACTIVE_COMPARATOR

Open Surgery

Intervention Type PROCEDURE

Open surgical abdominal aortic aneurysm repair

Interventions

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Powerlink infrarenal bifurcated stent graft delivery system

Endovascular abdominal aortic aneurysm repair

Intervention Type DEVICE

Open Surgery

Open surgical abdominal aortic aneurysm repair

Intervention Type PROCEDURE

Other Intervention Names

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Powerlink Stent Graft Delivery System

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Endologix

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rodney White, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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Arizona Heart Institute

Phoenix, Arizona, United States

Site Status

Harbor-UCLA Medical Center

Torrance, California, United States

Site Status

University of Illinois School of Medicine

Peoria, Illinois, United States

Site Status

SIU School of Medicine

Springfield, Illinois, United States

Site Status

Mercy Hospital

Des Moines, Iowa, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Barnes Jewish Hospital

St Louis, Missouri, United States

Site Status

Advanced Vascular Associates

Morristown, New Jersey, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, United States

Site Status

University Hospital of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Greenville Hospital System

Greenville, South Carolina, United States

Site Status

Heart Hospital of South Dakota

Sioux Falls, South Dakota, United States

Site Status

Vascular and Transplant Specialists

Norfolk, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 16760859 (View on PubMed)

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.

Reference Type RESULT
PMID: 16414382 (View on PubMed)

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.

Reference Type RESULT
PMID: 19088132 (View on PubMed)

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.

Reference Type RESULT
PMID: 18635335 (View on PubMed)

Other Identifiers

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TP00-005/CP04-001

Identifier Type: -

Identifier Source: org_study_id

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