NCT03734679已完成不适用
A Prospective, Multi-Center, Single-Arm Study to Assess the Safety and Performance of the Surmodics Drug Coated Balloon in the Treatment of Subjects With Obstructive Lesions of Arteriovenous Fistulae for Hemodialysis, Including Native or Synthetic Grafts
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Number of Participants With Target Lesion Primary Patency at 6 Months Post Procedure
研究概览
简要总结
The purpose of this study is to evaluate the safety and performance of the SurVeil DCB in subjects with obstructive lesions of arteriovenous fistulae for hemodialysis.
详细描述
AVess FIH is a prospective, multi-center, single arm, first-in-man feasibility study evaluating up to 15 subjects
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
- •Subjects must be ≥18 years of age.
- •Native AV fistula has been created ≥60 days prior to the index procedure.
- •AV fistula, located in the arm, has undergone one or more successful hemodialysis sessions.
- •Target de novo or non-stented restenotic lesion consisting of a ≥50% stenosis by operator visual estimate.
- •Fistula vessel diameter ≥5 mm and ≤7 mm by operator visual estimate.
- •Target lesion or tandem lesion ≤120 mm in total length by operator visual estimate.
- •Successful pre-dilatation of the target lesion. Defined as crossing of the guide wire AND pre-dilatation with a PTA balloon resulting in: residual stenosis of ≤30% and dissection ≤ Grade B
- •Subject has provided written informed consent and is willing to comply with study follow-up requirements.
- •Subject has a life expectancy of ≥1 year
排除标准
- •Subject has a synthetic AV graft.
- •Determined by operator to have a lesion that prevents complete inflation of an angioplasty balloon.
- •Presence of pseudoaneurysm or aneurysm requiring treatment at the lesion site.
- •Target lesion is located <30 mm from any stent.
- •Thrombosis of the access site 30 days prior to procedure.
- •Surgical revision of the access site planned within 30 days of procedure.
- •Blood coagulative disorder, sepsis, or current AV access infection (white blood count ≥12,000).
- •Known contraindication (including allergic reaction) or sensitivity to antiplatelet therapy, anticoagulation therapy or paclitaxel (mild to severe cases), that cannot be adequately managed with pre-and post-procedure medication.
- •Subjects who are taking immunosuppressive therapy or are routinely taking ≥10mg of prednisone per day.
- •Scheduled for kidney transplant or peritoneal dialysis within the next 6 months post procedure.
- •Myocardial infarction 30 days prior to procedure.
- •Stroke or TIA 90 days prior to procedure.
- •Women who are pregnant, breast-feeding or intend to become pregnant or men who intend to father children during the time of the study.
- •Subject is participating in any other investigational study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoint from this study.
结局指标
主要结局
Number of Participants With Target Lesion Primary Patency at 6 Months Post Procedure
时间窗: 6 months
Freedom from clinically-driven target lesion revascularization (CD-TLR) or access thrombosis
次要结局
- Number of Participants With Secondary Functional Patency(Through 6 months)
- Number of Participants With Patency of Target Lesion as Defined by Duplex Ultrasound (Reported by DUS Core Lab)(6 months)
- Number and Rate of Patients With Device and Procedure Related Adverse Events (CEC Adjudicated)(30 days)
- Number of Participants With Absence of All Cause Death up to 30 Days (CEC Adjudicated)(30 days)
- Number of Participants With Subsequent Reinterventions, Such as Angioplasty, Stent, Fistula, That Are Required to Maintain Target Lesion Patency (CEC-Adjudicated)(30 days and 6 months)
研究者
研究点 (4)
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