Study of the Endovascular QUANTUM LP™ Stent Graft System in Abdominal Aortic Aneurysms (AAA)
NCT ID: NCT00233688
Last Updated: 2009-05-01
Study Results
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Basic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2001-11-30
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
QUANTUM LP™ STENT GRAFT SYSTEM
QUANTUM LP™ STENT GRAFT SYSTEM
Stent Graft System for the Treatment of Abdominal Aortic Aneurysms
2
Surgical intervention
Open surgical repair
Open surgical repair
Interventions
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QUANTUM LP™ STENT GRAFT SYSTEM
Stent Graft System for the Treatment of Abdominal Aortic Aneurysms
Open surgical repair
Open surgical repair
Eligibility Criteria
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Inclusion Criteria
2. Patients 21 years of age or older
3. Male or infertile Female
4. Aneurysm \>/=4.5 cm in diameter, or
5. Aneurysm \>/= twice the normal aortic diameter directly above the aneurysm, or
6. Aneurysm \>/= 4.0 cm in diameter and rapidly growing (0.5 cm in 6 months), or
7. Saccular aneurysm \> 3.0 cm
2. Aneurysm starts \>/= 10 mm below the most distal main renal artery and the diameter of aorta within that aortic neck segment is not variable
3. Diameter of aortic fixation zone (neck) \>/= 22mm and \</= 30 mm
4. Supra renal aortic diameter \</= 34 mm
5. 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)
6. Aortic neck angulation \< 60° as estimated from CT scan images or angiogram
7. Iliac artery attachment zone diameter \</= 20 mm
8. Iliac arteries with a length of \>/= 10 mm of non-aneurysmal vessel located at the iliac graft attachment sites
9. Iliac arteries with adequate peripheral access to accommodate a 22 Fr catheter delivery system
10. Aortic bifurcation \> 18 mm in diameter
11. Creatinine level \< 2.5 mg/dl
Exclusion Criteria
2. Mycotic, ruptured or traumatic aneurysm
3. Life expectancy \< 2 years
4. MI, cerebral vascular accident or transient ischemic attack (TIA) within 6 months
5. Expected occlusion or the need for re-implantation of significant mesenteric or renal arteries originating from the AAA
1. Aneurysm is symptomatic or tender
2. Creatinine \> 2.5 mg/dl or patient on dialysis
3. Thrombus in proximal and distal attachment area covering greater than 50% of the endoluminal surface
21 Years
ALL
No
Sponsors
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Cordis Corporation
INDUSTRY
Responsible Party
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Cordis
Principal Investigators
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H. Wayne Hutman, MD
Role: STUDY_DIRECTOR
Cordis Corporation
Locations
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Newark Beth Israel Medical Center
Newark, New Jersey, United States
Countries
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Other Identifiers
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P01-4601
Identifier Type: -
Identifier Source: org_study_id
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