34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms

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Disease Information

Descriptive Information
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 Study of anatomical fixation with a 34mm proximal extension
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 Phase Phase 2/Phase 3
Study Type † Interventional
Study Design † Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Proximal Type I endoleak
Secondary Outcome Measure † Delivery success, deployment success, stent graft apposition to the vessel wall, device integrity, patency, occlusion, migration and Type III endoleak.
Condition † Abdominal Aortic Aneurysm
Intervention † DeviceEndologix Powerlink 34 mm stent graft cuff
Study Arms / Comparison Groups A Powerlink 34mm cuff stent graft
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Device
Estimated Enrollment † 60
Start Date † September 2005
Completion Date September 2012
Primary 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 1.7 mg/dl - Renal transplant patient - Proximal attachment site >60º angle to the aneurysm body - Iliac arteries >90º angle - 30% at implantation site
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT00706394
Organization ID CP03-023
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Endologix
Collaborators ††
Investigators † Principal Investigator: Edward Y Woo, MD, Hospital at the University of Pennsylvania, Philadelphia, PA 19104, United States
Information Provided By
Verification Date September 2011
First Received Date † May 2, 2008
Last Updated Date September 12, 2011
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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