34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms

Completed · Not applicable

Conditions studied: Abdominal Aortic Aneurysm

In brief

Study of anatomical fixation with a 34mm proximal extension

Key facts

Study ID

NCT00706394

Run by

Endologix

People needed

19

Starts

2007-08-10

Expected to finish

2013-09-01

Last updated by the study team

2021-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mount Sinai Medical Center — Miami, Florida, United States
• Baptist Cardiac and Vascular Institute — Miami, Florida, United States
• Baptist Hospital East — Louisville, Kentucky, United States
• St. Joseph Medical Center — Towson, Maryland, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Nebraska Heart Institute — Lincoln, Nebraska, United States
• Sisters of Charity Hospital — Buffalo, New York, United States
• Oklahoma Cardiovascular Associates — Oklahoma City, Oklahoma, United States
• Hospital at the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Lexington Medical Center — West Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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