NCT00850252已完成1 期
Use of a Completely Autologous and Completely Biological Tissue Engineered Blood Vessel Lifeline as an Arteriovenous Fistula in Hemodialysis Patients - Safety and Efficacy Study.
Cytograft Tissue Engineering2 个研究点 分布在 2 个国家开始时间: 2004年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
- 主要终点
- The primary purpose of this study will be to gain preliminary safety experience with Lifeline blood vessel as an arteriovenous fistula
研究概览
简要总结
This study will assess the safety and efficacy of a completely autologous and completely biological tissue engineered blood vessel (TEBV) called Lifeline™ used as an arteriovenous fistula for dialysis access.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have signed an informed consent
- •Patients ≥ 21 years old
- •Patients not candidates for a Brescia-Cimino A-V fistula (own vessels)
- •Have an AV shunt or fistula that will likely fail within 12 months because of:
- •Signs of clinical dysfunction: increment of venous pressure, limited site of puncture, stenosis, aneurysm dilatations that cannot be surgically repaired or by other media, or
- •Previous angioplasty, or
- •Previous thrombolysis
- •Fall into category of ASA grade 2 or below (or UK equivalent)
- •Are willing and able to comply with 2, 4, 6, 8, 10, 12, 16, 20, 24, 36 and 52 week follow up and able to comply with biannual follow up thereafter.
排除标准
- •A need for urgent surgery
- •Penicillin allergy
- •Patients with uncontrolled hypertension
- •Morbid obesity (> 300 lbs)
- •Active systemic infection
- •Contraindication for anticoagulation
- •Coagulopathy
- •Acute renal failure
- •Connective tissue diseases (i.e. Marfan's syndrome)
- •Pregnant or nursing
- •Life expectancy < 1 year
- •Participation in another study involving an investigational device or new drug
- •Other medical, social or psychological issues that, in the opinion of the principal investigator, preclude them from receiving the treatment and the procedures/evaluations of the post-operative follow up
- •Inability or unwillingness to comply with the scheduled follow-up visit
结局指标
主要结局
The primary purpose of this study will be to gain preliminary safety experience with Lifeline blood vessel as an arteriovenous fistula
时间窗: minimum 3 months
次要结局
- The secondary purpose of the study is to assess the efficacy of the Lifeline blood vessel used as hemodialysis access in ESRD patients(36 months)
研究者
研究点 (2)
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