NL-OMON40305已完成不适用
A prospective open-label non-randomized pivotal study to evaluate the safety and performance of the Horizon* Abdominal Aortic Aneurysm (AAA) Stent graft System. - The Horizon CE Pivotal Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
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 99（—）
入选标准
- •1. Male and female age >= 18.
- •2. Presence of at least one of the following:
- •i. Abdominal aortic aneurysm >= 5.0cm in diameter (perpendicular to the line of flow).
- •ii. Abdominal aortic aneurysm 4.5-5.5cm in diameter which increased in size - >= 0.5cm over 6 months or 1.0cm over one year.
- •iii. Abdominal aortic aneurysm >50% larger than the normal aortic diameter.
- •3. Patient is considered an appropriate candidate for an elective surgery, as evaluated by Physical Status Classification System I, II or III (American Society of Anesthesiologists).
- •4. Femoral artery diameter of >=6mm, documented by CTA or MRA that allows endovascular access to the aneurismal site with a 14 Fr delivery catheter.
- •5. Access vessels morphology suitable for endovascular repair in terms of tortuosity, calcification and angulation, documented by CTA or MRA.
- •6. To be eligible to receive the Horizon having the following characteristics, as demonstrated on CTA or MRA imaging:
- •I. Infrarenal aortic neck diameter of 18-28 mm
- •II. Aortic length (lower renal artery to lowest point of aortic bifurcation) of 115-150 mm
- •III. Iliac artery diameter of 10-19 mm
- •IV. Proximal aortic neck length >= 15 mm
- •V. Proximal aortic neck/ aneurysm angulation <= 60°
- •VI. Diameter measured 20mm above aortic bifurcation floor should be >= 20mm
- •VII. Aortic bifurcation angulation of >= 70°.
- •7. Patient understands and is voluntarily willing to participate as evidenced by personally signing the Informed Consent document.
排除标准
- •1. If female and of childbearing potential, patients who are:
- •a. less than 5 years post-menopausal or did not undergo hysterectomy, oophorectomy or tubal ligation and do not agree to take all measures to avoid pregnancy during the period of the study.
- •b. nursing.
- •2. Life expectancy of less than 1 year.
- •3. Any medical condition that, according to the investigator*s decision, might expose the patient to increased risk by the investigational device or procedure.
- •4. Patient is in need for an emergent surgery for a ruptured aneurysm.
- •5. Patient with an increased risk for aneurysm rupture during the procedure.
- •6. An Acutely ruptured or leaking aneurysm.
- •7. Acute traumatic dissection or vascular injury or penetrating ulcers of the aorta.
- •8. Presence of thrombus or atheroma in proximal aortic neck covering >50% of the endoluminal surface.
- •9. Presence of diffuse atherosclerotic disease in either common iliac artery that reduces the iliac artery diameter to <6mm.
- •10. Congenital vascular disease in which the placement of the stent graft will cause occlusion of major arterial flow.
- •11. Aneurysm with any of the following characteristics: suprarenal, isolated ilio-femoral, mycotic, inflammatory or para-anastomotic pseudoaneurysm.
- •12. Patient has an untreated thoracic aneurysm > 5.5 cm in diameter.
- •13. Patient has an aneurysm that involves the part of the aorta at the ostia of the renal arteries.
- •14. Patient has a reversed conical neck defined as a > 4mm distal increase over a 10 mm length.
- •15. Patient has ectatic iliac arteries requiring bilateral exclusion of hypogastric blood flow.
- •16. Patient whose arterial access site is not anticipated to accommodate the 14 Fr diameter of the Horizon* Delivery System, due to size, tortuosity or hostile groins (scarring, obesity, or previous failed puncture).
- •17. Patient underwent major surgery or interventional procedure in the last three months.
- •18. Patient is suffering from unstable angina or NYHA classification III and IV and/or ASA classification IV and above.
- •19. Patient has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 3 months prior to the planned implantation.
- •20. Patient has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
- •21. Contraindication to undergoing angiography.
- •22. Patients with known hypersensitivity or allergy to device materials - Nitinol and Polyester.
- •23. Morbid obesity or other clinical conditions that severely inhibit x-ray visualization of the aorta.
- •24. Connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndromes).
- •25. Patient has a history of bleeding diathesis or coagulopathy.
- •26. Active systemic infection at the time of the index procedure documented by either one of the following: pain, fever, drainage, positive culture and/or leukocytosis (WBC > 11,000 mm3).
- •27. Acute renal failure documented by either one of the following: Creatinine > 2.00 mg/dl or > 182 umol/L; patient on dialysis.
- •28. Any other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, or the procedures and evaluations pre- and post- treatment.
- •29. Active participation in another research study involving an investigational device or new drug.
研究者
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