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CompletedNCT00543270Updated Oct 5, 2021

Powerlink Bifurcated Stent Graft Long-Term Follow-up Study

An interventional study of Powerlink infrarenal bifurcated stent graft delivery system and Open Surgery in Abdominal Aortic Aneurysm, sponsored by Endologix. Completed at 14 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-05.

Sponsored by Endologix · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2009, 16 years 11 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
258
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Endologix Infrarenal Bifurcated Stent Graft Study

02

Conditions studied

  • Abdominal Aortic Aneurysm

Keywords

  • EVAR
  • AAA
  • Aneurysm
  • Powerlink
03

In context

Aneurysm

960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.

This study's enrollment of 258 is above the median of 72 across 462 interventional studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

Endologix is the lead sponsor of 25 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 9 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
258 participants (actual)

Study arms

  • Experimental
    Endovascular Repair - EVAR (Powerlink System)

    EVAR (Powerlink System)

    Device: Powerlink infrarenal bifurcated stent graft delivery system

  • Active comparator
    Open Surgical Control

    Open Surgical Control

    Procedure: Open Surgery

Interventions

  • DevicePowerlink infrarenal bifurcated stent graft delivery system

    Endovascular abdominal aortic aneurysm repair

    Also known as: Powerlink Stent Graft Delivery System

  • ProcedureOpen Surgery

    Open surgical abdominal aortic aneurysm repair

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: At 1 Year

  2. All Cause Mortality

    No of deaths reported through 1 year

    Time frame: At 1 Year

Secondary outcomes

  1. Stent Graft Performance

    Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration

    Time frame: 30 Days

  2. Stent Graft Performance

    Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration

    Time frame: 6 Months

  3. Stent Graft Performance

    Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration

    Time frame: Year 1

  4. Stent Graft Performance

    Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration

    Time frame: Year 2

  5. Stent Graft Performance

    Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration

    Time frame: Year 3

  6. Stent Graft Performance

    Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration

    Time frame: Year 4

  7. Stent Graft Performance

    Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration

    Time frame: Year 5

  8. Clinical Utility Outcomes

    Estimated anesthesia time, fluoroscopy time, procedure time

    Time frame: During the Procedure

  9. Clinical Utility Outcomes

    Estimated blood loss (ml) and contrast volume (ml). Estimated blood loss records the approximate amount of blood that the patient lost during the surgery (ml) and contract volume is the volume of the contrast (ml) calculated during the procedure.

    Time frame: During the Procedure

  10. Clinical Utility Outcomes

    Estimated ICU time

    Time frame: up to 1 week

  11. Clinical Utility Outcomes

    Estimated Hospitalization Time

    Time frame: up to 1 week

  12. Aneurysm Morphology

    Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to 6 Months

    Time frame: 6 Months

  13. Aneurysm Morphology

    Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 1

    Time frame: Year 1

  14. Aneurysm Morphology

    Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 2

    Time frame: Year 2

  15. Aneurysm Morphology

    Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 3

    Time frame: Year 3

  16. Aneurysm Morphology

    Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 4

    Time frame: Year 4

  17. Aneurysm Morphology

    Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 5

    Time frame: Year 5

07

Study locations

14 sites
  • Arizona Heart Institute
    Phoenix, Arizona 85006, United States
  • Harbor-UCLA Medical Center
    Torrance, California 90506, United States
  • University of Illinois School of Medicine
    Peoria, Illinois 61604, United States
  • SIU School of Medicine
    Springfield, Illinois 62702, United States
  • Mercy Hospital
    Des Moines, Iowa 50314, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Barnes Jewish Hospital
    Saint Louis, Missouri 63110, United States
  • Advanced Vascular Associates
    Morristown, New Jersey 07960, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • Oklahoma Cardiovascular Research Group
    Oklahoma City, Oklahoma 73120, United States
  • University Hospital of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Greenville Hospital System
    Greenville, South Carolina 29605, United States
  • Heart Hospital of South Dakota
    Sioux Falls, South Dakota 57108, United States
  • Vascular and Transplant Specialists
    Norfolk, Virginia 23510, United States
08

References and documents

Publications

  • 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. PubMed 16760859 ↗
  • 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. PubMed 16414382 ↗
  • 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. PubMed 19088132 ↗
  • 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. PubMed 18635335 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00543270
Lead sponsor
Endologix
Responsible party
Sponsor
First posted
Oct 12, 2007
Start date
Oct 2005
Primary completion
Nov 2009
Completion
Nov 2009
Last update
Oct 5, 2021

Study contacts

Rodney White, MD
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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