NL-OMON54411已完成不适用
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - A Prospective Multicenter Study. - AAA-SHAPE_NLD
Shape Memory Medical0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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
- •1. >=18 years of age.
- •2. A candidate for elective EVAR of an infrarenal aortic aneurysm >=5.5 cm in
- •diameter in men and >=5.0 cm in women.
排除标准
- •1. An inability to provide informed consent.
- •2. Enrolled in another clinical study.
- •3. Aortoiliac aneurysm, or concomitant iliac artery ectasia or aneurysm (common
- •iliac artery diameter >24 mm) close to the bifurcation and/or that cannot be
- •adequately sealed.
- •4. Patent AAA sac feeding vessels (within the sac) >4 mm in diameter.
- •5. Volume of AAA sac to be filled after stent graft placement <20 mL or >135
- •mL, based on pre-procedure CTA (i.e., aortic flow volume exclusive of stent
- •graft volume).
- •6. Use of aortic stent grafts other than the Gore Excluder AAA Endoprosthesis,
- •Cook Zenith Flex AAA Endovascular Graft, or Medtronic Endurant II Stent Graft
- •to treat the AAA.
- •7. Planned use of the chosen stent graft outside its instructions for use (IFU).
- •8. Planned use of fenestrated or chimney stent grafts.
- •9. Study participants in which stent graft placement is abandoned for any
- •reason, and/or in which the investigator decides, during the course of the
- •stent graft placement, that the study procedure may not be appropriate.
- •10. Planned use of embolic devices other than the investigational product to
- •embolize the AAA sac.
- •11. Vascular disease and/or anatomy that preclude the safe access and
- •positioning of a catheter to deliver the investigational product into the AAA
- •12. Ruptured, leaking, or mycotic (infected) aneurysm.
- •13. Aneurysmal disease of the descending thoracic aorta.
- •14. Coagulopathy or uncontrolled bleeding disorder.
- •15. Long-term (>6 months prior to the procedure) use of direct oral
- •anticoagulant or any vitamin K antagonist anticoagulant use.
- •16. Serum creatinine level >2.5 mg/dL.
- •17. Cerebrovascular accident within 3 months prior to the procedure.
- •18. Myocardial infarction and/or major heart surgery within 3 months prior to
- •the procedure.
- •19. Atrial fibrillation that is not well rate controlled.
- •20. Unable or unwilling to comply with study follow-up requirements.
- •21. Life expectancy of <2 years post-procedure.
- •22. Known hypersensitivity or contraindication to platinum, iridium, or
- •polyurethane.
- •23. A condition that inhibits radiographic visualization during the
- •implantation procedure.
- •24. History of allergy to contrast medium that cannot be managed medically.
- •25. Uncontrolled co-morbid medical condition, including mental health issues,
- •that would adversely affect participation in the study.
- •26. Pregnant or a lactating female. For females of child-bearing potential,
- •based on a positive pregnancy test within 7 days prior to the procedure or
- •refusal to use a medically accepted method of birth control for the duration of
- •27. Member of a vulnerable population.
研究者
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