Status:
COMPLETED
Study of the Endovascular QUANTUM LP™ Stent Graft System in Abdominal Aortic Aneurysms (AAA)
Lead Sponsor:
Cordis US Corp.
Conditions:
Abdominal Aortic Aneurysm
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief Summary
The objective of this clinical study is to assess the safety and effectiveness of the Cordis Endovascular Quantum LP™ Stent Graft System.
Eligibility Criteria
Inclusion
- Inclusion Criteria (Surgical Patients):
- Non-emergent surgical candidate (aneurysm has not ruptured)
- Patients 21 years of age or older
- Male or infertile Female
- Aneurysm \>/=4.5 cm in diameter, or
- Aneurysm \>/= twice the normal aortic diameter directly above the aneurysm, or
- Aneurysm \>/= 4.0 cm in diameter and rapidly growing (0.5 cm in 6 months), or
- Saccular aneurysm \> 3.0 cm
- Inclusion Criteria (Stent Graft Patients)
- Patient meets all inclusion criteria for surgical candidate
- Aneurysm starts \>/= 10 mm below the most distal main renal artery and the diameter of aorta within that aortic neck segment is not variable
- Diameter of aortic fixation zone (neck) \>/= 22mm and \</= 30 mm
- Supra renal aortic diameter \</= 34 mm
- The required device coverage length \>/= 13 cm extending from most distal main renal artery ostium to the distal anchoring site within the common iliac artery (or external iliac artery if planned occlusion of internal iliac artery)
- Aortic neck angulation \< 60° as estimated from CT scan images or angiogram
- Iliac artery attachment zone diameter \</= 20 mm
- Iliac arteries with a length of \>/= 10 mm of non-aneurysmal vessel located at the iliac graft attachment sites
- Iliac arteries with adequate peripheral access to accommodate a 22 Fr catheter delivery system
- Aortic bifurcation \> 18 mm in diameter
- Creatinine level \< 2.5 mg/dl
- Exclusion Criteria (Surgical and Stent Graft Patients):
- Weight \> 350 lbs. (159 Kg)
- Mycotic, ruptured or traumatic aneurysm
- Life expectancy \< 2 years
- MI, cerebral vascular accident or transient ischemic attack (TIA) within 6 months
- Expected occlusion or the need for re-implantation of significant mesenteric or renal arteries originating from the AAA
- Exclusion Criteria (Stent Graft Patients only)
- Aneurysm is symptomatic or tender
- Creatinine \> 2.5 mg/dl or patient on dialysis
- Thrombus in proximal and distal attachment area covering greater than 50% of the endoluminal surface
Exclusion
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00233688
Start Date
November 1 2001
End Date
April 1 2009
Last Update
May 1 2009
Active Locations (1)
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1
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112