NL-OMON54373招募中不适用
Feasibility assessment of the prophylactic Use of AneuFix at the time of EVAR implantation - AneuFix - PSF
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
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. Asymptomatic, infrarenal AAA that requires surgery with a high- risk profile
- •of developing endoleak type II
- •2. Infrarenal neck according to the IFU of the EVAR device
- •3. Other aortic-iliac anatomical configuration suitable for EVAR according to
- •the criteria of the EVAR device to be used
- •4. Patient having a life expectation of at least 2 years
- •5. Being older than 18 years
- •6. Willing and able to comply with the requirements of this clinical study
排除标准
- •1. Patient not able or willing to give written Informed Consent
- •2. Patient undergoing emergency procedures
- •3. Patient undergoing EVAR for ruptured or symptomatic AAA,
- •4. Patient with a suprarenal AAA
- •5. Patient with an inflammatory AAA (more than minimal wall thickening)
- •6. Patient with an infrarenal neck unsuitable for endovascular fixation
- •(including so called *hostile necks*) or aortic-iliac anatomic configuration
- •otherwise unsuitable for EVAR according to criteria of the device to be used
- •7. Patient in which a bilateral retroperitoneal incision is required for EVAR
- •8. Patient in which a sacrifice of both hypogastric arteries is required
- •9. Patient with anatomical variations
- •10. Patient in which the administration of contrast agent is not possible:
- •proved, severe systemic reaction to contrast agent
- •11. Patient with active infection present
- •12. Patients scheduled for or having received an organ transplant
- •13. Patient with limited life expectation due to other illness (<1 year)
- •14. Patient with non-iatrogenic bleeding diathesis
- •15. Patient with connective tissue disease
- •16. Women of child-bearing potential
- •17. Patients with evidence at completion angiogram during EVAR of a type Ia or
- •type III endoleak persistent after balloon inflation.
研究者
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