Study of the Endovascular QUANTUM LP™ Stent Graft System in Abdominal Aortic Aneurysms (AAA)
A Prospective, Multicenter Study of the Cordis Endovascular QUANTUM LP™ Stent Graft System for the Treatment of Abdominal Aortic Aneurysms (AAA)-FORTRON
The objective of this clinical study is to assess the safety and effectiveness of the Cordis Endovascular Quantum LP™ Stent Graft System.
To compare the aneurysm-related one-year mortality rates of the stent graft patients to open surgery patients. The purpose of having an aneurysm surgically or endovascularly repaired is to prevent death from AAA.
To evaluate the occurrence of severe device-related adverse events as they relate to the cause of aneurysm exclusion failures (i.e., Type I and III endoleaks, significant AAA growth, or AAA rupture).
Abdominal Aortic Aneurysm
QUANTUM LP™ STENT GRAFT SYSTEM
Study Arms / Comparison Groups
Description: QUANTUM LP™ STENT GRAFT SYSTEM
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
Inclusion Criteria (Surgical Patients): 1. Non-emergent surgical candidate (aneurysm has not ruptured) 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 Inclusion Criteria (Stent Graft Patients) 1. Patient meets all inclusion criteria for surgical candidate 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 (Surgical and Stent Graft Patients): 1. Weight > 350 lbs. (159 Kg) 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 Exclusion Criteria (Stent Graft Patients only) 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 - N/A
Accepts Healthy Volunteers
H. Wayne Hutman, MD, ,
H. Wayne Hutman, MD, Study Director, Cordis Corporation