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34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Endologix.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00706394
First Posted: June 27, 2008
Last Update Posted: September 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Endologix
  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 2 Phase 3

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
Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Endologix:

Primary Outcome Measures:
  • Proximal Type I endoleak [ Time Frame: One year ]

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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00706394


Locations
United States, Florida
Mount Sinai Medical Center
Miami, Florida, United States, 33140
Baptist Cardiac and Vascular Institute
Miami, Florida, United States, 33176
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:
Responsible Party: Endologix
ClinicalTrials.gov Identifier: NCT00706394     History of Changes
Other Study ID Numbers: CP03-023
First Submitted: May 2, 2008
First Posted: June 27, 2008
Last Update Posted: September 14, 2011
Last Verified: September 2011

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