First in Human Evaluation of STARgraft AV for Hemodialysis Access in Comparison to ePTFE Vascular Grafts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Primary Unassisted Patency
研究概览
简要总结
This study is a First-in-Human, single site, prospective, randomized, controlled evaluation of the safety and effectiveness of the Healionics STARgraft AV hemodialysis access graft. The STARgraft has been demonstrated in preclinical studies to have improved resistance to the common failure mode of venous anastomosis stenosis.
Performance of the STARgraft AV will be compared against control implants of commercially available standard ePTFE grafts approved for the same use.
The study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft. The study proposes to:
- Demonstrate improved primary patency of the investigational STARgraft AV compared to the ePTFE controls over a period of 6 months, with extended results to 1 year.
- Verify safety of the STARgraft AV multilayer construction in extended vascular access use.
It is intended to enroll 25 subjects each for the investigational devices and the controls respectively (50 total) with randomized device allocation at subject presentation for implant surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Randomized Assignment of Investigational and Control devices by Sponsor. Participants and Dialysis Clinics providing routine maintenance hemodialysis care are masked.
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
- •Male or female, > 18 years or age.
- •Patient has given informed consent to participate in the trial.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Able to effectively communicate with study personnel.
- •Candidate for a new arterio-venous graft placed in the upper arm.
- •Life expectancy judged to be at least 2 years.
- •Axillary vein of greater than or equal to 7 mm in diameter.
- •Brachial artery of greater than or equal to 4 mm in diameter.
- •Systolic blood pressure equal to or greater than 120 mmHg.
- •Absence of central venous stenosis downstream from implant site confirmed with ultrasound and/or angiogram.
排除标准
- •Unable or unlikely to comply with trial protocol and/or follow-up.
- •Clinical morbid obesity.
- •Anatomical limitations.
- •Immunodeficiency syndrome.
- •History of bacterial infection within 8 weeks prior to graft implantation.
- •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 of the veins downstream of the implant site.
- •Inadequate arterial flow or pressure proximal to the implant site.
- •Currently participating in another investigation drug or device study which may clinically interfere with any endpoints of this trial.
- •Fever greater than 38° C.
- •Prior allergic reaction to silicone.
结局指标
主要结局
Primary Unassisted Patency
时间窗: 12 months post implantation.
Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency.
次要结局
- Primary Unassisted Patency(1, 2, 4, 9 and 12 months post implantation)
- Secondary Patency (Cumulative Patency)(1, 2, 4, 6, 9 and 12 months post implantation)
- Graft Related Infections(1, 2, 4, 6, 9 and 12 months post implantation)
- Assisted Primary Patency(1, 2, 4, 6, 9 and 12 months post implantation)
- Safety Outcomes(1, 2, 4, 6, 9 and 12 months post implantation)