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Powerlink Bifurcated Stent Graft Long-Term Follow-up Study

Primary Purpose

Abdominal Aortic Aneurysm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Powerlink infrarenal bifurcated stent graft delivery system
Open Surgery
Sponsored by
Endologix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm focused on measuring EVAR, AAA, Aneurysm, Powerlink

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Heart Institute
  • Harbor-UCLA Medical Center
  • University of Illinois School of Medicine
  • SIU School of Medicine
  • Mercy Hospital
  • Mayo Clinic
  • Barnes Jewish Hospital
  • Advanced Vascular Associates
  • Cleveland Clinic
  • Oklahoma Cardiovascular Research Group
  • University Hospital of Pennsylvania
  • Greenville Hospital System
  • Heart Hospital of South Dakota
  • Vascular and Transplant Specialists

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endovascular Repair - EVAR (Powerlink System)

Open Surgical Control

Arm Description

EVAR (Powerlink System)

Open Surgical Control

Outcomes

Primary Outcome Measures

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
All Cause Mortality
No of deaths reported through 1 year

Secondary Outcome Measures

Stent Graft Performance
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Stent Graft Performance
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Stent Graft Performance
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Stent Graft Performance
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Stent Graft Performance
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Stent Graft Performance
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Stent Graft Performance
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Clinical Utility Outcomes
Estimated anesthesia time, fluoroscopy time, procedure time
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.
Clinical Utility Outcomes
Estimated ICU time
Clinical Utility Outcomes
Estimated Hospitalization Time
Aneurysm Morphology
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to 6 Months
Aneurysm Morphology
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 1
Aneurysm Morphology
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 2
Aneurysm Morphology
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 3
Aneurysm Morphology
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 4
Aneurysm Morphology
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 5

Full Information

First Posted
October 10, 2007
Last Updated
September 30, 2021
Sponsor
Endologix
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1. Study Identification

Unique Protocol Identification Number
NCT00543270
Brief Title
Powerlink Bifurcated Stent Graft Long-Term Follow-up Study
Official Title
Endologix Powerlink Long-Term Follow-up Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endologix

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Endologix Infrarenal Bifurcated Stent Graft Study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm
Keywords
EVAR, AAA, Aneurysm, Powerlink

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endovascular Repair - EVAR (Powerlink System)
Arm Type
Experimental
Arm Description
EVAR (Powerlink System)
Arm Title
Open Surgical Control
Arm Type
Active Comparator
Arm Description
Open Surgical Control
Intervention Type
Device
Intervention Name(s)
Powerlink infrarenal bifurcated stent graft delivery system
Other Intervention Name(s)
Powerlink Stent Graft Delivery System
Intervention Description
Endovascular abdominal aortic aneurysm repair
Intervention Type
Procedure
Intervention Name(s)
Open Surgery
Intervention Description
Open surgical abdominal aortic aneurysm repair
Primary Outcome Measure Information:
Title
No of Subjects with Major adverse events
Description
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
Title
All Cause Mortality
Description
No of deaths reported through 1 year
Time Frame
At 1 Year
Secondary Outcome Measure Information:
Title
Stent Graft Performance
Description
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Time Frame
30 Days
Title
Stent Graft Performance
Description
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Time Frame
6 Months
Title
Stent Graft Performance
Description
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Time Frame
Year 1
Title
Stent Graft Performance
Description
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Time Frame
Year 2
Title
Stent Graft Performance
Description
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Time Frame
Year 3
Title
Stent Graft Performance
Description
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Time Frame
Year 4
Title
Stent Graft Performance
Description
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Time Frame
Year 5
Title
Clinical Utility Outcomes
Description
Estimated anesthesia time, fluoroscopy time, procedure time
Time Frame
During the Procedure
Title
Clinical Utility Outcomes
Description
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
Title
Clinical Utility Outcomes
Description
Estimated ICU time
Time Frame
up to 1 week
Title
Clinical Utility Outcomes
Description
Estimated Hospitalization Time
Time Frame
up to 1 week
Title
Aneurysm Morphology
Description
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to 6 Months
Time Frame
6 Months
Title
Aneurysm Morphology
Description
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 1
Time Frame
Year 1
Title
Aneurysm Morphology
Description
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 2
Time Frame
Year 2
Title
Aneurysm Morphology
Description
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 3
Time Frame
Year 3
Title
Aneurysm Morphology
Description
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 4
Time Frame
Year 4
Title
Aneurysm Morphology
Description
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 5
Time Frame
Year 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodney White, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Heart Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90506
Country
United States
Facility Name
University of Illinois School of Medicine
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61604
Country
United States
Facility Name
SIU School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Mercy Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Advanced Vascular Associates
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oklahoma Cardiovascular Research Group
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
University Hospital of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Heart Hospital of South Dakota
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Vascular and Transplant Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16760859
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.
Results Reference
result
PubMed Identifier
16414382
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. doi: 10.1016/j.jvs.2005.09.025.
Results Reference
result
PubMed Identifier
19088132
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. doi: 10.1177/1538574408327570. Epub 2008 Dec 16.
Results Reference
result
PubMed Identifier
18635335
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. doi: 10.1016/j.jvs.2008.04.031. Epub 2008 Jul 16.
Results Reference
result

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Powerlink Bifurcated Stent Graft Long-Term Follow-up Study

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