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34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms

This study is ongoing, but not recruiting participants.
Study NCT00706394.   Last updated on June 26, 2008.   Information provided by Endologix

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Descriptive Information Fields
Brief Title  34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms
Official Title  Prospective, Multicenter, Single Arm Phase II Study of the Powerlink 34mm Cuff for the Endovascular Repair of Abdominal Aortic Aneurysms
Brief Summary

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.

Detailed Description
Study Phase Phase II, Phase III
Study Type  Interventional
Study Design  Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure  Proximal Type I endoleak [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure  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 ]
Condition  Abdominal Aortic Aneurysm
Intervention  Device: Endologix Powerlink 34 mm stent graft cuff
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  60
Start Date  September 2005
Completion Date September 2012
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00706394
Organization ID CP03-023
Secondary IDs ††
Study Sponsor  Endologix
Collaborators ††
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    
Information Provided By Endologix
Verification Date June 2008
First Received Date  May 2, 2008
Last Updated Date June 26, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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