NL-OMON42913已完成不适用
everlinQ endoAVF EU Study - everlinQ endoAVF EU 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. Adult (age >18 years old)
- •2. Established, non-reversible kidney failure requiring hemodialysis (stage 4 or 5 renal disease) including pre-dialysis patients
- •3. Target treatment vein diameter(s) for fistula creation >= 2.0 mm as measured via Duplex Ultrasound or Venogram
- •4. Target treatment artery diameter >= 2.0 mm as measured via Duplex Ultrasound of Arteriogram
- •5. Both radial and ulnar artery flow to the hand
排除标准
- •1. Known central venous stenosis or central vein narrowing > 50% based on imaging on the same side as the planned AVF creation
- •2. Absence of perforator feeding the target cannulation vein(s) via Venogram
- •3. Occlusion or stenosis >50% of target cannulation cephalic or basilic vein
- •4. Target cannulation vein that is >6 mm deep
- •5. Target cannulation vein that is <2.5 mm in diameter
- •6. Significantly compromised (>=50% stenosis) flow in the treatment arm as determined by physician and imaging
- •NOTE: patients that have >=50% arterial stenosis my undergo a Digital Brachial Index (DBI) test, if DBI result is <.65 patient is excluded
- •7. Documented ejection fraction (EF) <=35% in the last 6 months
- •8. Pregnant women
- •9. New York Heart Association (NYHA) class III or IV heart failure
- •10. Hypercoagulable state
- •11. Known bleeding diathesis
- •12. Immunosuppression, defined as use of immunosuppressive medications used to treat an active condition
- •13. Documented history of drug abuse including intravenous drugs within six months of AVF creation
- •14. *Planned* concomitant major surgical procedure within 6 months of enrollment or previous major surgery within 30 days of enrollment
- •15. Known allergy to contrast dye which cannot be adequately pre-medicated
- •16. Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated
- •17. Evidence of active infections on the day of the index procedure
- •18. Estimated life expectancy < 1 year
- •19. Patient is not willing to provide written informed consent, is not geographically stable and/or not willing to comply with required follow-up
研究者
相似试验
招募中
不适用
EVA Study (ESHRE / VCUAM / ASRM)GENITALEFEHLBILDUNGEDRKS00025001niversitätsklinik für Gynäkologie,Geburtshilfe und gynäkologischer Endokrinologie, Kepleruniversitätsklinikum Johannes Kepler Universität Linz150
撤回
不适用
European CURE AF study, Concomitant Uitlization of Radiofrequency Energy for Atrail Fibrillatioheart rhythm diseaseirregular heart rhythm10007521NL-OMON33162Medtronic20
撤回
不适用
A European, Multi-Centre Study to Evaluate the Value of Real-Time Elastography in the Diagnosis of Prostate CarcinomaProstate adenocarcinoma10038364prostate cancerNL-OMON38888Academisch Medisch Centrum30
招募中
不适用
Multicenter European prospective study on the efficacy and safety of the Focal C2 CryoBalloon Ablation System in patients with Barrett*s Esophagus-related neoplasiaNL-OMON50590Sint Antonius Ziekenhuis42
招募中
不适用
Efficacy and safety of focal cryoballoon ablation for patients with dysplastic Barrett's esophagusNL-OMON25207St. Antonius Hospital, Nieuwegein107