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优点 WRAPSODY AV 访问效率研究 (WAVE) (WAVE)

2026年5月14日 更新者：Merit Medical Systems, Inc.

前瞻性、随机、对照、多中心研究，比较 Merit WRAPSODY™ 血管内支架移植物与经皮腔内血管成形术治疗血液透析患者的静脉流出回路狭窄或闭塞。波研究

该研究的目的是证明 Merit WRAPSODY 血管内覆膜支架治疗透析通路流出回路内的狭窄或闭塞的安全性和有效性

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

357

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

  • 加拿大
      • Toronto、加拿大
        • Toronto General Hospital
  • 巴西
      • Brasília、巴西
        • Instituto Santa Marta De Ensino E Pesquisa
      • Recife、巴西
        • Real Hospital Português de Beneficência em Pernambuco
      • Rio de Janeiro、巴西
        • Hospital Universitário Pedro Ernesto
      • São Paulo、巴西
        • Instituto Dante Pazzanese de Cardiologia
  • 美国
    • Arizona
      • Tempe、Arizona、美国、85281
        • Southwest Kidney institute (SKI) Vascular Center
      • Tucson、Arizona、美国、85718
        • PIMA Heart and Vascular
    • California
      • Orange、California、美国、92868
        • St. Joseph Hospital
    • Connecticut
      • Darien、Connecticut、美国、06820
        • Vascular Care Connecticut
    • Delaware
      • Newark、Delaware、美国、19713
        • Nephrology Associates
    • Florida
      • Jacksonville、Florida、美国、32256
        • First Coast Cardiovascular Institute
      • Miami、Florida、美国、33169
        • Open Access Miami, LLC
      • Oscala、Florida、美国、34471
        • Leesburg Vascular Access Center & Discovery Medical Research
      • Pensacola、Florida、美国、32504
        • Coastal Vascular and Interventional
    • Illinois
      • Chicago、Illinois、美国、60611
        • Northwestern Medical Center
      • Chicago、Illinois、美国、60559
        • Chicago Access Center
    • Indiana
      • Indianapolis、Indiana、美国、46202
        • Indiana University Hospital and Methodist Hospital
    • Kentucky
      • Ashland、Kentucky、美国、41101
        • King's Daughters Medical Center
    • Massachusetts
      • West Roxbury、Massachusetts、美国、02130
        • Brigham and Women's Faulkner Hospital
    • Michigan
      • Flint、Michigan、美国、48507
        • Michigan Vascular Access Center
    • New Jersey
      • Vineland、New Jersey、美国、80360
        • Vascular Institute of Atlantic Medical Imaging
    • North Carolina
      • Chapel Hill、North Carolina、美国、27599
        • UNC Health
      • Charlotte、North Carolina、美国、28202
        • Charlotte Radiology
      • Raleigh、North Carolina、美国、27607
        • NC Heart and Vascular Research
      • Raleigh、North Carolina、美国、27610
        • North Carolina Nephrology Raleigh Access
    • Ohio
      • Cleveland、Ohio、美国、44195
        • Cleveland Clinic
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15213
        • University Pittsburg Medical Center
    • Rhode Island
      • Providence、Rhode Island、美国、02906
        • Providence Access Center
    • South Carolina
      • Greenville、South Carolina、美国、29605
        • Prisma Health System Upstate
    • Texas
      • Dallas、Texas、美国、75235
        • Renal Disease Research Institute
      • Dallas、Texas、美国、75226
        • Soltero Cardiovascular Research Center
      • Fort Worth、Texas、美国、76104
        • PPG Health PA, DBA-Tarrant Vascular
      • Houston、Texas、美国、77030
        • Houston Methodist Hospital
      • Houston、Texas、美国、77008
        • Global Kidney Associates
      • Katy、Texas、美国、77494
        • University of Texas Health - Memorial Hermann Katy Hospital
      • Pasadena、Texas、美国、77504
        • CDVA
      • Plano、Texas、美国、75093
        • Dallas Nephrology Associates
    • Virginia
      • Virginia Beach、Virginia、美国、23507
        • Sentara Vascular Specialists
  • 英国
      • Birmingham、英国、B15 2TH
        • Queen Elizabeth Hospital
      • Dorchester、英国
        • Dorset County Hospital
      • London、英国、E1 1FR
        • Royal London Hospital
      • Oxford、英国、OX3 7LE
        • Churchill Hospital
      • Stevenage、英国、SG1 4AB
        • Lister Hospital

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

描述

纳入标准：

  • 受试者提供书面知情同意书
  • 受试者是男性或女性，在入组之日年龄≥ 18 岁。
  • 受试者愿意接受所有后续评估。
  • 受试者的预期寿命≥ 12 个月。
  • 对象正在进行慢性血液透析。
  • 受试者手臂上有成熟的 AVF 或 AVG。
  • 目标病变涉及新发狭窄或非支架再狭窄病变。
  • 靶病变有 ≥ 50% 的狭窄。
  • 目标病变参考血管直径在 5.0 毫米和 14.0 毫米之间

排除标准：

  • 受试者患有血液透析通路部位的已知或疑似感染、全身感染和/或败血症。
  • 受试者在入组前 3 个月内被诊断为中风。
  • 受试者在入组前 60 天内有不稳定型心绞痛或心肌梗塞病史。
  • 受试者怀孕、哺乳或打算在明年内怀孕。
  • 目标病变位于支架/覆膜支架内。

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：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：AVF外周研究治疗组
随机接受 WRAPSODY 血管内覆膜支架治疗的受试者
设备：Merit WRAPSODY 血管内覆膜支架
支架移植物放置治疗的目标病变
其他：AVF 周边对照组
受试者随机接受标准经皮腔内血管成形术 (PTA) 治疗
设备：PTA
标准经皮腔内血管成形术 (PTA) 治疗的目标病变
实验性的：AVG吻合术
该单臂队列中的所有受试者都将接受 WRAPSODY 血管内覆膜支架治疗
设备：Merit WRAPSODY 血管内覆膜支架
支架移植物放置治疗的目标病变

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
Subjects Without Any Localized or Systemic Safety Events (Primary Safety Endpoint)
大体时间：30 days
Percentage of subjects without any localized or systemic safety events through 30 days post-index procedure that affect the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including stenosis or thrombosis). Endovascular procedures performed to treat safety events after the index study procedure will be considered surgeries.
30 days
Subjects With Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint:)
大体时间：6 months
Percentage of subjects with Target Lesion Primary Patency (TLPP) at 6 Months. TLPP is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.
6 months

次要结果测量

结果测量
措施说明
大体时间
Subjects With Target Lesion Primary Patency
大体时间：12 months
Percentage of subjects with Target Lesion Primary Patency (TLPP) at 12 Months. TLPP is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.
12 months
Subjects With Target Lesion Primary Patency
大体时间：24 months
Percentage of subjects with Target Lesion Primary Patency (TLPP) at 24 Months. TLPP is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.
24 months
Subjects With Assisted Target Lesion Primary Patency (aTLPP)
大体时间：6 months

Kaplan Meier Estimate Percent Probability of Assisted Target Lesion Primary Patency at 6 months.

aTLPP was defined as time to loss of Assisted Primary Patency of the target lesion, which is the time from post-procedure until uncorrectable target lesion occlusion. Participants who did not experience loss of aTLPP were censored at the time of last available follow-up.
6 months
Subjects With Assisted Target Lesion Primary Patency (aTLPP)
大体时间：12 months

Kaplan Meier Estimate Percent Probability of Assisted Target Lesion Primary Patency at 12 months.

aTLPP was defined as time to loss of Assisted Primary Patency of the target lesion, which is the time from post-procedure until uncorrectable target lesion occlusion. Participants who did not experience loss of aTLPP were censored at the time of last available follow-up.
12 months
Subjects With Assisted Target Lesion Primary Patency (aTLPP)
大体时间：24 months

Kaplan Meier Estimate Percent Probability of Assisted Target Lesion Primary Patency at 24 months.

aTLPP was defined as time to loss of Assisted Primary Patency of the target lesion, which is the time from post-procedure until uncorrectable target lesion occlusion. Participants who did not experience loss of aTLPP were censored at the time of last available follow-up.
24 months
Subjects With Access Circuit Primary Patency (ACPP)
大体时间：6 months
6 months
Subjects With Access Circuit Primary Patency (ACPP)
大体时间：12 months
12 months
Subjects With Access Circuit Primary Patency (ACPP)
大体时间：24 months
24 months
Subjects With Post-Procedure Secondary Patency
大体时间：6 months

Kaplan Meier Estimate Percent Probability of Post-Procedure Secondary Patency at 6 months.

Post-Procedure Secondary Patency was defined as the interval post-procedure until access circuit abandonment. Participants who did not experience loss of Post-Procedure Secondary Patency were censored at the time of last available follow-up.
6 months
Subjects With Post-Procedure Secondary Patency
大体时间：12 months

Kaplan Meier Estimate Percent Probability of Post-Procedure Secondary Patency at 12 months.

Post-Procedure Secondary Patency was defined as the interval post-procedure until access circuit abandonment. Participants who did not experience loss of Post-Procedure Secondary Patency were censored at the time of last available follow-up.
12 months
Subjects With Post-Procedure Secondary Patency
大体时间：24 months

Kaplan Meier Estimate Percent Probability of Post-Procedure Secondary Patency at 24 months.

Post-Procedure Secondary Patency was defined as the interval post-procedure until access circuit abandonment. Participants who did not experience loss of Post-Procedure Secondary Patency were censored at the time of last available follow-up.
24 months
Rates of Procedure-related Adverse Events Involving the Access Circuit
大体时间：Index procedure
Rates of procedure-related adverse events involving the access circuit at index procedure
Index procedure
Rates of Device-related Adverse Events Involving the Access Circuit
大体时间：Index procedure
Rates of device-related adverse events involving the access circuit at index procedure
Index procedure
Rates of Procedure-related Adverse Events Involving the Access Circuit
大体时间：30 days
Rates of procedure-related adverse events involving the access circuit at 30 days
30 days
Rates of Device-related Adverse Events Involving the Access Circuit
大体时间：30 days
Rates of device-related adverse events involving the access circuit at 30 days
30 days
Rates of Procedure-related Adverse Events Involving the Access Circuit
大体时间：6 months
Rates of procedure-related adverse events involving the access circuit at 6 months
6 months
Rates of Device-related Adverse Events Involving the Access Circuit
大体时间：6 months
Rates of device-related adverse events involving the access circuit at 6 months
6 months
Rates of Procedure-related Adverse Events Involving the Access Circuit
大体时间：12 Months
Rates of procedure-related adverse events involving the access circuit at 12 months
12 Months
Rates of Device-related Adverse Events Involving the Access Circuit
大体时间：12 Months
Rates of device-related adverse events involving the access circuit at 12 months
12 Months
Rates of Procedure-related Adverse Events Involving the Access Circuit
大体时间：24 Months
Rates of procedure-related adverse events involving the access circuit at 24 months
24 Months
Rates of Device-related Adverse Events Involving the Access Circuit
大体时间：24 Months
Rates of device-related adverse events involving the access circuit at 24 months
24 Months

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。

赞助

Merit Medical Systems, Inc.

调查人员

  • 首席研究员：Robert Jones, MD、The Queen Elizabeth Hospital
  • 首席研究员：Mahmood K Razavi, MD、St. Joseph's Hospital, Orange, CA

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)

2021年3月9日

初级完成 (实际的)

2024年2月22日

研究完成 (实际的)

2025年7月25日

研究注册日期

首次提交

2020年9月1日

首先提交符合 QC 标准的

2020年9月1日

首次发布 (实际的)

2020年9月7日

研究记录更新

最后更新发布 (实际的)

2026年6月10日

上次提交的符合 QC 标准的更新

2026年5月14日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CVO-P3-20-01

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

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.

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