Evaluation of STARgraft AV for Hemodialysis Access
2021年10月8日 更新者：Healionics Corporation
First in Human Evaluation of STARgraft AV for Hemodialysis Access in Comparison to ePTFE Vascular Grafts
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.
研究概览
研究类型
介入性
注册 (实际的)
55
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Asunción、巴拉圭
- Italian Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Unable or unlikely to comply with trial protocol and/or follow-up.
- Pregnancy.
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：STARgraft AV
Participants will be implanted with 6mm diameter STARgraft AV grafts as an upper arm Brachial Artery to Axillary Vein shunt for hemodialysis access.
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Implant of STARgraft AV shunt in the upper arm and subsequent use for hemodialysis access.
After healing from the surgical procedure the graft will be routinely cannulated for hemodialysis sessions.
Periodic evaluations of blood flow by ultrasound imaging will be made over the study period.
Established standards of care will be followed as needed to maintain dialysis function.
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有源比较器：Control (ePTFE)
Participants will be implanted in the same upper arm location with standard 6mm diameter ePTFE dialysis access grafts.
All other aspects of this study arm are identical to the Experimental one.
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Implant of standard ePTFE AV shunt as a control in the upper arm and subsequent use for hemodialysis access.
After healing from the surgical procedure the graft will be routinely cannulated for hemodialysis sessions.
Periodic evaluations of blood flow by ultrasound imaging will be made over the study period.
Established standards of care will be followed as needed to maintain dialysis function.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Primary Unassisted Patency
大体时间：12 months post implantation.
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Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency.
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12 months post implantation.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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初级无辅助通畅
大体时间：植入后 1、2、4、9 和 12 个月
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没有发生通路血栓形成或为保持通畅而执行的通路程序的受试者百分比。
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植入后 1、2、4、9 和 12 个月
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辅助初级通畅
大体时间：植入后 1、2、4、6、9 和 12 个月
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只要在任何时候都没有失去通畅性，在一次或多次干预后保持通畅性的受试者百分比。
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植入后 1、2、4、6、9 和 12 个月
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二级通畅率（累积通畅率）
大体时间：植入后 1、2、4、6、9 和 12 个月
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在原始植入部位没有失去通路的受试者百分比。
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植入后 1、2、4、6、9 和 12 个月
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安全成果
大体时间：植入后 1、2、4、6、9 和 12 个月
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移植物植入和用于血液透析通路导致的不良事件的频率和严重程度。
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植入后 1、2、4、6、9 和 12 个月
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Graft Related Infections
大体时间：1, 2, 4, 6, 9 and 12 months post implantation
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Frequency of infections related to graft placement and use for dialysis access.
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1, 2, 4, 6, 9 and 12 months post implantation
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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峰值收缩速度 (PSV) 比率
大体时间：植入后 2 周和 1、2、4、6、9、12 个月
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PSV的超声测量（静脉吻合处的流速与移植物上游2cm处的流速之比）
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植入后 2 周和 1、2、4、6、9、12 个月
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Blood flow rates in grafts.
大体时间：2 weeks and 1, 2, 4, 6, 9, 12 months post implantation.
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Ultrasound measurements of flow rates (ml/minute) to detect patency trends with time after implantation
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2 weeks and 1, 2, 4, 6, 9, 12 months post implantation.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年4月2日
初级完成 (实际的)
2020年10月17日
研究完成 (实际的)
2021年5月11日
研究注册日期
首次提交
2019年4月8日
首先提交符合 QC 标准的
2019年4月12日
首次发布 (实际的)
2019年4月16日
研究记录更新
最后更新发布 (实际的)
2021年10月13日
上次提交的符合 QC 标准的更新
2021年10月8日
最后验证
2021年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
STARgraft AV的临床试验
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University Hospital, Gentofte, CopenhagenRigshospitalet, Denmark; Lund University Hospital未知
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Columbia UniversityNational Institute of Neurological Disorders and Stroke (NINDS)完全的
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Northwestern UniversityNational Institute on Aging (NIA)招聘中
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Vasomune Therapeutics, Inc.招聘中
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Avid RadiopharmaceuticalsEli Lilly and Company完全的
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University of California, San Diego完全的