NL-OMON47483已完成不适用
Endurant Evo International Clinical Trial<br> - EEVO
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- Subject is at least 18 years old
- •- Subject is a suitable candidate for elective surgical repair of AAA as
- •evaluated by American Society of Anesthesiologists (ASA) Physical Status
- •Classification System I, II, or III
- •- Subject has an infrarenal abdominal aortic or aortoiliac aneurysm
- •characterized by one or more of the following:
- •a) Aneurysm is > 5 cm in diameter (diameter measured is perpendicular to the
- •line of flow)
- •b) Aneurysm is 4 * 5 cm in diameter and has increased in size * 0.5 cm within
- •the previous 6 months
- •- Subject meets all the following anatomical criteria as demonstrated on
- •contrast-enhanced CT or MRA imaging:
- •a) Proximal neck length of * 10 mm with * 60° infrarenal and * 45° suprarenal
- •neck angulation or Proximal neck length of * 15 mm with * 75° infrarenal and *
- •60° suprarenal neck angulation
- •b) Subject has vascular dimensions, e.g., aortic and iliac diameters, lengths
- •from renal arteries to iliac bifurcation and hypogastric arteries, in the range
- •of sizes available for the Endurant Evo AAA stent graft system (measured intima
- •to intima) and within the sizing recommendations (refer to Endurant Evo AAA
- •stent graft system Instructions for Use (IFU))
- •c) Subject has a proximal aortic neck diameter *18 mm and *32 mm
- •d) The distal fixation center of the iliac arteries must have a diameter *7 mm
- •and * 25 mm bilaterally for the bifur and unilaterally for the AUI
- •e) Subject has documented imaging evidence of at least one patent iliac and one
- •femoral artery, or can tolerate a vascular conduit that allows introduction of
- •the Endurant Evo AAA stent graft system
- •f) Subject has distal non-aneurysmal iliac (cylindrical) fixation length * 20
- •mm bilaterally for the bifur and unilaterally for the AUI
排除标准
- •- Subject has a life expectancy * 1 year
- •- Subject has an aneurysm that is:
- •a. Suprarenal/ pararenal/ juxtarenal
- •b. Isolated ilio-femoral
- •d. Inflammatory
- •e. Pseudoaneurysm
- •f. Dissecting
- •g. Ruptured
- •h. Leaking but not ruptured
- •- Subject requires emergent aneurysm treatment
- •- Subject has a known, untreated thoracic aneurysm >4.5 cm in diameter at time
- •of screening
- •- Subject has been previously treated for an abdominal aortic aneurysm
- •- Subject has a history of bleeding diathesis or coagulopathy
- •- Subject has had or plans to have an unrelated major surgical or
- •interventional procedure within 1 month before or after implantation of the
- •Endurant Evo AAA Stent Graft
- •- Subject has had a myocardial infarction (MI) or cerebral vascular accident
- •(CVA) within 3 months prior to implantation of the Endurant Evo AAA Stent Graft
- •- Subject has a conical neck defined as a >4 mm distal increase from the
- •lowest renal artery over a 10 mm length
- •- Subject has a known allergy or intolerance to the device materials
- •- Subject has a known hypersensitivity or contraindication to anticoagulants,
- •antiplatelets, or contrast media, which is not amenable to pre-treatment
- •- Subject has significant aortic thrombus and/or calcification at either the
- •proximal or distal attachment centers that would compromise fixation and seal
- •of the device at the discretion of the investigator
- •- Subject has ectatic iliac arteries requiring bilateral exclusion of
- •hypogastric blood flow
- •- Subject whose arterial access site is not anticipated to accommodate the
- •diameter of the Endurant Evo AAA delivery system (13F-17F) due to vessel size,
- •calcification, or tortuosity
- •- Subject is morbidly obese or has other documented clinical conditions that
- •severely inhibit radiographic visualization of the aorta at the discretion of
- •the investigator
- •- Subject has active infection at the time of the index procedure documented by
- •e.g. pain, fever, drainage, positive culture and/or leukocytosis considered to
- •be clinically significant per investigator discretion
- •- Subject has congenital degenerative collagen disease, e.g., Marfan*s Syndrome
- •- Subject has a creatinine level >2.00 mg/dl (or >176.8 µmol/L)
- •- Subject is on dialysis
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