NCT07557862尚未招募不适用
Multi-Site Randomized Controlled Trial of STARgraft (10401) Vascular Graft for Hemodialysis Access
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 111
- 试验地点
- 7
研究概览
简要总结
This is a multi-site, single-blind with parallel group, randomized controlled trial of Healionics STARgraft (10401) vascular graft for hemodialysis access compared with a market-leading commercially available ePTFE vascular graft (Gore Propaten Vascular Graft).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
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 patient requires the creation of vascular access for hemodialysis secondary to a diagnosis of End-Stage Renal Disease (ESRD) and intends to use the Vascular Graft device for arteriovenous (AV) access.
- •The patient is currently on hemodialysis or intended to begin hemodialysis within 60 days following placement of the device.
- •Adult patients, 18 years or older.
- •Patient has given informed consent to participate in the trial.
- •Stated willingness to comply with all trial procedures and availability for the duration of the trial.
- •Able to effectively communicate with trial personnel.
- •Life expectancy judged to be at least 2 years with consideration of patient frailty.
- •Axillary vein approximately 7 mm in diameter or greater.
- •Brachial artery approximately 4 mm in diameter or greater.
- •Acceptable cardiac risk level (Cardiac Output ≥ 3.5 L/min, Pulmonary Artery Pressure ≤ 50 mmHg, and Ejection Fraction ≥ 40%).
- •Systolic blood pressure equal to or greater than 120 mmHg.
- •Absence of central venous stenosis downstream from implant site confirmed with ultrasound and/or venogram.
排除标准
- •Unable or unlikely to comply with trial protocol and/or follow-up.
- •Previous history of peritoneal dialysis (PD) treatment within the last 2 months
- •Central venous catheter located on same side as intended implant location.
- •Clinical morbid obesity (BMI > 40).
- •Anatomical limitations, including issues discovered intraoperatively during vessel exposure.
- •Immunodeficiency syndrome.
- •History of hypercoagulation or bleeding disorders.
- •Elevated platelet count > 1 million per microliter of blood.
- •History of heparin-induced thrombocytopenia syndrome (HIT).
- •Medically confirmed stenosis or compromised valves in the veins downstream of the implant site.
- •Inadequate arterial flow or pressure proximal to the implant site.
- •Currently participating in another investigational drug or device trial which may clinically interfere with any endpoints of this trial.
- •Fever greater than 38°C.
- •Known allergic reaction to silicone.
- •Confirmed or suspected bacterial, viral or parasitic infection within 8 weeks prior to graft implant, or ongoing symptoms.
- •Uncontrolled or poorly controlled diabetes.
- •History or evidence of severe cardiac disease.
- •Any other condition which, in the judgment of the Investigator, would preclude adequate evaluation or impact patient safety or trial conduct.
研究组 & 干预措施
STARgraft (10401)
Experimental
干预措施: STARgraft (10401) (Device)
Gore Propaten
Active Comparator
干预措施: Gore Propaten (Device)
研究者
研究点 (7)
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