34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms

October 22, 2021 updated by: Endologix

Prospective, Multicenter, Single Arm Phase II Study of the Powerlink 34mm Cuff for the Endovascular Repair of Abdominal Aortic Aneurysms

Study of anatomical fixation with a 34mm proximal extension

Study Overview

Status

Completed

Detailed Description

The 34mm proximal extension stent graft is intended to augment the primary 28mm infrarenal bifurcated stent graft to accommodate patient anatomy (neck diameters up to 32mm) and provide an effective seal to prevent/repair proximal Type I endoleaks.

Study Type

Interventional

Enrollment (Actual)

19

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

    • Florida
      • Miami, Florida, United States, 33176
        • Baptist Cardiac and Vascular Institute
      • Miami, Florida, United States, 33140
        • Mount Sinai Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Baptist Hospital East
    • Maryland
      • Towson, Maryland, United States, 21204
        • St. Joseph Medical Center
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Nebraska Heart Institute
    • New York
      • Buffalo, New York, United States, 14214
        • Sisters of Charity Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Cardiovascular Associates
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital at the University of Pennsylvania
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Lexington Medical Center

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:

  • 18 years old or older
  • Informed consent understood and signed
  • Will comply with protocol follow-up requirements
  • Candidate for conventional open surgical repair
  • Aneurysm outer diameter is one or more of the following:

    • greater than or equal to 4.0cm
    • greater than or equal to 3.0cm (saccular aneurysm)
    • greater than or equal to twice the normal aortic outer diameter
    • rapidly growing (greater than or equal to 5mm over 6 months)
  • Proximal non-aneurysmal aortic neck fixation length greater than or equal to 1.5cm between the renal arteries and the aneurysm
  • Non-aneurysmal proximal aortic neck inner diameter between 23 and 32mm
  • Iliac artery internal diameter greater than or equal to 8 mm

Exclusion Criteria:

  • Life expectancy <2 years
  • Participating in another clinical study
  • Pregnant or lactating women
  • Acutely ruptured/leaking aneurysm
  • Traumatic vascular injury
  • Other medical or psychiatric problems
  • Contraindication to non-ionic contrast media or anticoagulants
  • Coagulopathy or bleeding disorder
  • Active systemic or localized groin infection
  • Indispensable inferior mesenteric artery
  • Connective tissue disease (e.g., Marfan's Syndrome)
  • Creatinine level >1.7 mg/dl
  • Renal transplant patient
  • Proximal attachment site >60º angle to the aneurysm body
  • Iliac arteries >90º angle
  • <1.5 cm of non-aneurysmal common iliac artery above the iliac bifurcation on both sides [One internal iliac artery is required to remain patent]
  • Thrombus >30% at implantation site

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Powerlink 34mm cuff stent graft
Endovascular abdominal aortic aneurysm repair
Other Names:
  • Endologix Powerlink 34mm cuff [model 34-34-80L]

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Proximal Type I Endoleak at Each Timepoint
Time Frame: Five years
Percentage of patients with Type Ia endoleaks at each timepoint (discharge, 1, 6, 12, 24, 36, 48 and 60 months).
Five years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Successful Delivery and Deployment of the Device
Time Frame: 1 Month
Successful delivery and deployment of the device with no complication.
1 Month
Number of Participants With Type III Endoleaks at Each Timepoint
Time Frame: 5 Years
Percentage of patients with a Type III endoleaks at the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab.
5 Years
Number of Participants With Stent Fracture at Each Timepoint
Time Frame: 5 Years
Percentage of patients with a stent fracture over the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by the CoreLab.
5 Years
Number of Participants With Stent Graft Obstruction at Each Timepoint
Time Frame: 5 Years
Percentage of patients with a stent graft obstruction at each timepoint (1, 6, 12, 24, 36, 48 and 60 Months) as reported by Corelab.
5 Years
Number of Participants With Migration at Each Timepoint
Time Frame: 5 Years
Percentage of patients presenting a migration at each timepoint (1, 6, 12, 24, 36, 48, 60 Months) as reported by Corelab.
5 Years
Number of Participants With Type II Endoleaks at Each Timepoint
Time Frame: 5 Years
Percentage of patients with Type II endoleak at each time point (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab.
5 Years
Number of Participants With Aneurysm Diameter Change at Each Timepoint
Time Frame: 5 Years
Percentage of patients with a decrease, stable or increase aneurysm diameter at 6, 12, 24, 36, 48 and 60 Months compared to 1 Month as reported by CoreLab.
5 Years
Maximum Diameter Measurements
Time Frame: 5 Years
Maximum Diameter changes compared to the pre-operative at each timepoint (1, 6, 12, 24, 36, 48 Months).
5 Years
Aneurysm Volume Measurements
Time Frame: 5 Years
Aneurysm Volume changes over each time point (1, 6, 12, 24, 36, 48 and 60 Months) compared to pre-operative as reported by CoreLab.
5 Years

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Edward Y Woo, MD, Hospital at the University of Pennsylvania, Philadelphia, PA 19104, United States
  • Principal Investigator: O. W. Brown, MD, William Beaumont Hospital, Royal Oak, MI 48073, United States
  • Principal Investigator: James G. Melton, DO, Oklahoma Cardiovascular Research Group, Oklahoma City, OK 73120, United States
  • Principal Investigator: Steven H. Tyndall, MD, Nebraska Heart Hospital, Lincoln, NE 68526, United States
  • Principal Investigator: William M. Moore, MD, Lexington Medical Center, West Columbia, SC 29169, United States
  • Principal Investigator: Salem George, MD, Baptist Hospital East, Louisville, KY 40207, United States
  • Principal Investigator: Kerry C. Prewitt, MD, St. Joseph Medical Center, Towson, MD 21204, United States
  • Principal Investigator: Paul Anain, MD, Sisters of Charity Hospital, Buffalo, NY 14214, United States
  • Principal Investigator: Robert Beasley, MD, Mount Sinai Medical Center, Miami Beach, FL 33140, United States
  • Principal Investigator: Barry T. Katzen, MD, Baptist Cardiac and Vascular Institute, Miami, FL 33176, United States

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 (ACTUAL)

August 10, 2007

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

May 2, 2008

First Submitted That Met QC Criteria

June 26, 2008

First Posted (ESTIMATE)

June 27, 2008

Study Record Updates

Last Update Posted (ACTUAL)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 22, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

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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