Powerlink Bifurcated Stent Graft Long-Term Follow-up Study

September 30, 2021 updated by: Endologix

Endologix Powerlink Long-Term Follow-up Study

Endologix Infrarenal Bifurcated Stent Graft Study

Study Overview

Study Type

Interventional

Enrollment (Actual)

258

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endovascular Repair - EVAR (Powerlink System)
EVAR (Powerlink System)
Endovascular abdominal aortic aneurysm repair
Other Names:
  • Powerlink Stent Graft Delivery System
Active Comparator: Open Surgical Control
Open surgical abdominal aortic aneurysm repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
No of Subjects with Major adverse events
Time Frame: At 1 Year
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
Time Frame: At 1 Year
No of deaths reported through 1 year
At 1 Year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

October 10, 2007

First Submitted That Met QC Criteria

October 11, 2007

First Posted (Estimate)

October 12, 2007

Study Record Updates

Last Update Posted (Actual)

October 5, 2021

Last Update Submitted That Met QC Criteria

September 30, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • TP00-005/CP04-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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