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34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms
This study is ongoing, but not recruiting participants.

First Received on May 2, 2008.   Last Updated on September 12, 2011   History of Changes
Sponsor: Endologix
Information provided by (Responsible Party): Endologix
ClinicalTrials.gov Identifier: NCT00706394
  Purpose

Study of anatomical fixation with a 34mm proximal extension


Condition Intervention Phase
Abdominal Aortic Aneurysm
 Device: Endologix Powerlink 34 mm stent graft cuff
 Phase II
Phase III

Endologix has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Multicenter, Single Arm Phase II Study of the Powerlink 34mm Cuff for the Endovascular Repair of Abdominal Aortic Aneurysms

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Aortic Aneurysm
U.S. FDA Resources

Further study details as provided by Endologix:

Primary Outcome Measures:
  • Proximal Type I endoleak [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Delivery success, deployment success, stent graft apposition to the vessel wall, device integrity, patency, occlusion, migration and Type III endoleak. [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2005
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Powerlink 34mm cuff stent graft
 Device: Endologix Powerlink 34 mm stent graft cuff
Endovascular abdominal aortic aneurysm repair
Other Name: Endologix Powerlink 34mm cuff [model 34-34-80L]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00706394

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

Publications:
Jordan WD Jr, Moore WM Jr, Melton JG, Brown OW, Carpenter JP; Endologix Investigators. Secure fixation following EVAR with the Powerlink XL System in wide aortic necks: results of a prospective, multicenter trial. J Vasc Surg. 2009 Nov;50(5):979-86. Epub 2009 Aug 12.

Responsible Party: Endologix
ClinicalTrials.gov Identifier: NCT00706394     History of Changes
Other Study ID Numbers: CP03-023
Study First Received: May 2, 2008
Last Updated: September 12, 2011
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

Keywords provided by Endologix:
Powerlink
34mm
Abdominal Aortic Aneurysm
EVAR

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on February 12, 2012



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