NCT00233688已完成3 期
A Prospective, Multicenter Study of the Cordis Endovascular QUANTUM LP™ Stent Graft System for the Treatment of Abdominal Aortic Aneurysms (AAA)-FORTRON
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
The objective of this clinical study is to assess the safety and effectiveness of the Cordis Endovascular Quantum LP™ Stent Graft System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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 \/= 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 \/= 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
排除标准
- •(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
研究组 & 干预措施
1
Experimental
QUANTUM LP™ STENT GRAFT SYSTEM
干预措施: QUANTUM LP™ STENT GRAFT SYSTEM (Device)
2
Active Comparator
Surgical intervention
干预措施: Open surgical repair (Procedure)
结局指标
主要结局
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.
时间窗: One year
To compare the one-year procedure-related severe adverse event rates of the stent graft patients to open surgery patients. These events exclude aneurysm-related deaths. The endpoint for this objective will be the occurrence of any serious adverse eve
时间窗: One year
次要结局
- 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).(30 days, 6 mo, and annually up to five years)
- To compare the rate and amount of blood products used in the stent graft procedure to open surgery.(At procedure)
研究者
研究点 (1)
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