NCT05228132终止不适用
A Prospective, Multi-Center, Single-Arm Clinical Study of the Pristine™ Long-Term Hemodialysis Catheter
C. R. Bard12 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2022年5月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 142
- 试验地点
- 12
- 主要终点
- Overall Complication Rate of the Pristine™ Catheter
研究概览
简要总结
This is a prospective, multi-center, single-arm study designed to assess the safety and performance of the Pristine™ Long-Term Hemodialysis Catheter.
详细描述
A total of 142 patients will be enrolled and have the Pristine™ Long-Term Hemodialysis Catheter placed. Under the current enrollment assumptions, up to 15 investigational sites in the United States (US) will participate. Eligible participants will have End Stage Renal Disease requiring hemodialysis through a tunneled dialysis catheter. Follow-up for all enrolled participants will be performed at 1-month, 3-months, 6-months, and 12-months post-Index Procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •The participant or legally designated representative must voluntarily sign and date the approved Informed Consent Form (ICF) prior to collection of study-specific data or performance of study-specific procedures.
- •The participant must be willing and able to comply with protocol requirements, including all study visits and procedures.
- •The participant must be either a male or non-pregnant female ≥18 years of age.
- •The participant must have a diagnosis of End Stage Renal Disease with indication for a tunneled dialysis catheter creation.
- •Participant must require chronic hemodialysis treatments 3 times per week with intended use of the Pristine™ Long-Term Hemodialysis Catheter.
- •The participant meets the indications for hemodialysis use and does not meet any of the contraindications per the Pristine Instructions for Use (IFU).
- •The participant must have a patent jugular vein or subclavian vein.
排除标准
- •The participant has known central venous stenosis
- •Based on the local primary investigator's discretion, the patient would not be an appropriate study candidate.
- •The participant has already undergone an AVF or AVG procedure and is awaiting maturation.
- •The participant has an active infection at the time of study enrollment.
- •The participant has a presence of bacteremia or infection within 7 days prior to enrollment.
- •The participant has a history neutropenia or a history of severe immunodeficiency disease.
- •The participant has uncontrolled abnormal coagulation parameters and are at additional risk for clotting or excessive bleeding at time of enrollment per physicians opinion.
- •The participant has a known allergy, intolerance or sensitivity to heparin, or previous incidence of heparin-induced thrombocytopenia.
- •The participant has a known allergy or hypersensitivity to any of the device materials or Ethylene oxide (EtO).
- •The participant has another medical condition or treatment, which in the opinion of the investigator, the participant may be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for completion of study procedures and follow-up.
- •The participant is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational but have since become commercially available, are not considered investigational studies.
结局指标
主要结局
Overall Complication Rate of the Pristine™ Catheter
时间窗: At 3 months post index procedure.
The combined Primary Endpoint is the overall rate of infectious complications and non-infectious complications requiring revision to maintain patency and improve access performance, evaluated against a performance goal (PG) derived from the Dialysis Outcomes and Practice Patterns Study (DOPPS) data.
次要结局
- Rate of Technical Success(At time of Index Procedure.)
- Rate of Freedom From Catheter-related Bloodstream Infection (CRBSI)(1-month Post-Index Procedure.)
- Rate of Freedom From Device and/or Procedure-related Adverse Events(1-month Post-Index Procedure.)
- Overall Participant Survival Rate(1-month Post-Index Procedure.)
- Overall Catheter Survival Rate(1-month Post-Index Procedure)
- Overall Patency Rate(1-month Post-Index Procedure)
研究者
研究点 (12)
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