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34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms

This study is ongoing, but not recruiting participants.

Sponsored by: Endologix
Information provided by: Endologix
ClinicalTrials.gov Identifier: NCT00706394
  Purpose

The 34mm proximal cuff 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.


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

MedlinePlus related topics:   Aneurysms   

U.S. FDA Resources

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

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:   May 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental
Powerlink 34mm cuff stent graft
Device: Endologix Powerlink 34 mm stent graft cuff
Endovascular abdominal aortic aneurysm repair

  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

Responsible Party:   Endologix ( Janet Fauls / VP, Regulatory, Quality, and Clinical Affairs )
Study ID Numbers:   CP03-023
First Received:   May 2, 2008
Last Updated:   June 26, 2008
ClinicalTrials.gov Identifier:   NCT00706394
Health Authority:   United States: Food and Drug Administration;   United States: Institutional Review Board

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

Study placed in the following topic categories:
Aortic Diseases
Aneurysm
Aortic Aneurysm, Abdominal
Abdominal aortic aneurysm
Vascular Diseases
Aortic Aneurysm

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2008

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