FLEX FIRST Registry Research Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 4
- 主要终点
- Target Lesion Primary Patency Rate
研究概览
简要总结
Prospective, observational study evaluating the clinical use and outcomes of the FLEX Vessel Prep (VP) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities following 12 months post treatment.
详细描述
Prospective, observational study evaluating the clinical use and outcomes of the FLEX Vessel Prep (VP) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities in real-world subjects per the Institution's standard practice and at 1-, 6-, and 12-months following treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Subject is ≥18 years of age.
- •Subject is currently scheduled to undergo an endovascular intervention of arteriovenous fistula or graft due to clinical and hemodynamic abnormalities meeting the KDOQI Guidelines for AV access dysfunction:
- •Elevated venous pressure during hemodialysis,
- •Abnormal physical findings, and
- •Unexplained decrease in delivered dialysis dose.
- •Subject has a reasonable expectation of remaining on hemodialysis for ≥12 months.
- •Subject is legally competent, informed of the study, voluntarily agrees to participate, and signs the informed consent form.
- •Subject understands the study and is willing and able to comply with the follow-up requirements.
排除标准
- •Subject has a known or suspected systemic infection.
- •Subject has a known or suspected infection of the hemodialysis graft.
- •Subject has an untreatable allergy to radiographic contrast material.
- •In the opinion of the operating physician, the subject's hemodialysis access is unsuitable for endovascular treatment.
结局指标
主要结局
Target Lesion Primary Patency Rate
时间窗: 6 months post procedure
Defined as freedom from clinically driven target lesion re-intervention (CD-TLR) or access circuit thrombosis measured through 6-months post- procedure.
Serious Adverse Event Rate
时间窗: 1 month
Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit through 1-month post-procedure.
次要结局
未报告次要终点