NCT04070365已完成不适用
FLEX Arteriovenous Access Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 10
- 主要终点
- Anatomic Success
研究概览
简要总结
Evaluation of the FLEX Vessel Prep system combined with angioplasty in the treatment of arteriovenous access stenosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemodialysis patient currently scheduled to undergo an intervention of their arteriovenous fistula or graft due to clinical or hemodynamic abnormalities.
- •The patient is ≥18 years of age. Patient is legally competent, has been informed of the study, voluntarily agrees to participate, and has signed the inform consent form.
- •The patient has a reasonable expectation of remaining on hemodialysis for 12 months.
- •The patient understands the study and is willing and able to comply with follow-up requirements.
- •The patient is willing to provide informed consent.
排除标准
- •The patient has a known or suspected systemic infection.
- •The patient has a known or suspected infection of the hemodialysis graft.
- •The patient has an untreatable allergy to radiographic contrast material.
- •In the opinion of the operating physician, the patient's hemodialysis access is unsuitable for endovascular treatment.
结局指标
主要结局
Anatomic Success
时间窗: At the completion of the index procedure
Defined as the angiographic percentage of stenosis post procedure as \<30%
次要结局
- Procedural Success(6 Months)
- Access Secondary Patency(6, 9, and 12 Months)
- Technical Success of the Device(At the index procedure)
- Clinical Success(6 Months)
- Circuit Primary Patency(6, 9, and Months)
- Target Lesion Primary Patency(6, 9 and 12 Months)
- Assisted Primary Patency(6, 9, and 12 Months)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
不适用
FLEX FIRST Registry Research ProtocolArteriovenous GraftArterial Occlusive DiseasesFistulaArteriovenous FistulaNCT05616104VentureMed Group Inc.130
已完成
不适用
Novel Endovascular Access Trial (NEAT)Chronic Kidney DiseaseNCT02036671C. R. Bard80
已完成
不适用
everlinQ Endovascular Access System Enhancements (EASE) StudyChronic Kidney DiseasesNCT03708770C. R. Bard32
终止
不适用
Trial Comparing One-stage With Two-stage Basilic Vein TranspositionBrachiobasilic Arteriovenous FistulaNCT01274117University of Patras16
已完成
不适用
Zilver® Flex™ Vascular Stent StudyPeripheral Arterial Disease (PAD)NCT00827619Cook Group Incorporated110