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 Type
Interventional
Primary Outcome
Number of Participants With Proximal Type I Endoleak at Each Timepoint
Secondary Outcome
Number of Participants With Successful Delivery and Deployment of the Device
Condition
Abdominal Aortic Aneurysm
Intervention
Endologix Powerlink 34 mm stent graft cuff
Study Arms / Comparison Groups
A
Description: 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
19
Start Date
August 10, 2007
Completion Date
September 2013
Primary Completion Date
September 2013
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
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Edward Y Woo, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00706394
Organization ID
CP03-023
Responsible Party
Sponsor
Study Sponsor
Endologix
Study Sponsor
Edward Y Woo, MD, Principal Investigator, Hospital at the University of Pennsylvania, Philadelphia, PA 19104, United States
Verification Date
October 2021