Status:
COMPLETED
34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms
Lead Sponsor:
Endologix
Conditions:
Abdominal Aortic Aneurysm
Eligibility:
All Genders
18+ years
Phase:
NA
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 se...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 10 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00706394
Start Date
August 10 2007
End Date
September 1 2013
Last Update
November 1 2021
Active Locations (10)
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1
Mount Sinai Medical Center
Miami, Florida, United States, 33140
2
Baptist Cardiac and Vascular Institute
Miami, Florida, United States, 33176
3
Baptist Hospital East
Louisville, Kentucky, United States, 40207
4
St. Joseph Medical Center
Towson, Maryland, United States, 21204