Springfield, Illinois 62702

  • Abdominal Aortic Aneurysm

Purpose:

Powerlink Bifurcated Infrarenal long-term follow-up study


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


Study is Available At:


Original ID:

TP00-005/CP04-001


NCT ID:

NCT00543270


Secondary ID:


Study Acronym:


Brief Title:

Powerlink Bifurcated Stent Graft Long-Term Follow-up Study


Official Title:

Endologix Powerlink Long-Term Follow-up Study


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Endologix


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

231


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Rodney White, MD
Principal Investigator
University of California, Los Angeles

Study Dates

Start Date:October 2005
Completion Date:November 2009
Completion Type:Actual
Primary Completion Date:November 2009
Primary Completion Type:Actual
Verification Date:February 2010
Last Changed Date:February 22, 2010
First Received Date:October 10, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:Safety: Major adverse events. Effectiveness: Stent graft patency, aneurysm exclusion, aneurysm related mortality, and all-cause mortality.
Time Frame:Through 10 years
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Powerlink infrarenal bifurcated stent graft delive
Description:Endovascular abdominal aortic aneurysm repair
Arm Name:A
Other Name:Powerlink Stent Graft Delivery System
Intervention Type:Procedure
Name:Open Surgery
Description:Open surgical abdominal aortic aneurysm repair
Arm Name:B

Study Arms

Study Arm Type:Experimental
Arm Name:A
Description:EVAR (Powerlink System)
Study Arm Type:Active Comparator
Arm Name:B
Description:Open Surgical Control

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Endologix

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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. Epub 2008 Jul 16.
PMID:18635335
Reference Type:Results Reference
Citation:Wang GJ, Carpenter JP. EVAR in small versus large aneurysms: does size influence outcome? Vasc Endovascular Surg. 2009 Jun-Jul;43(3):244-51. Epub 2008 Dec 16.
PMID:19088132
Reference Type:Results Reference
Citation: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.
PMID:16414382
Reference Type:Results Reference
Citation: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:16760859

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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