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Amsterdam Investigator-initiateD Absorb Strategy All-comers Trial (AIDA)

2019年1月8日 更新者:J.J. Wykrzykowska、Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Amsterdam Investigator-initiateD Absorb Strategy All-comers Trial (AIDA Trial): A Clinical Evaluation Comparing the Efficacy and Performance of ABSORB™ Everolimus Eluting Bioresorbable Vascular Scaffold Strategy Versus the XIENCE Family (XIENCE PRIME™ or XIENCE Xpedition™) Everolimus Eluting Coronary Stent Strategy in the Treatment of Coronary Lesions in Consecutive All-comers.

To evaluate the efficacy and performance in an all-comers contemporary population of the ABSORB bioresorbable vascular scaffolds (BVS) strategy versus the XIENCE family (XIENCE PRIME or XIENCE Xpedition) everolimus eluting coronary stent system in the treatment of coronary lesions.

研究概览

详细说明

The AIDA trial is a prospective, randomized (1:1), active control, single blinded, four-center, all-comers, non-inferiority trial. A total of 1845 patients were enrolled. The study population includes both simple and complex lesions, as well as stable and acute coronary syndrome patients. The follow-up will continue for 5 years including clinical endpoint characteristics.

研究类型

介入性

注册 (实际的)

1845

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

      • Amsterdam、荷兰
        • Onze Lieve Vrouwe Gasthuis
      • Dordrecht、荷兰
        • Albert Schweitzer Hospital
      • Hilversum、荷兰
        • Tergooi Hospital
      • Leeuwarden、荷兰
        • Medical center Leeuwarden
    • Noord-Holland
      • Amsterdam、Noord-Holland、荷兰、1105 AZ
        • AMC

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:

  • Subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions and the Instructions for Use of the ABSORB BVS strategy and XIENCE family.
  • Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ABSORB BVS strategy and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.

Exclusion Criteria:

  • Subject is younger than 18 years of age
  • Subject has a true bifurcation lesion where a priori two scaffold/stent strategy is planned.
  • Unsuccessful predilation of one or more of the planned lesion to be treated.
  • Planned treatment of in-stent restenosis of a previously placed metallic stent.
  • Subject has one or more lesion planned to be treated with a scaffold/stent diameter size smaller than 2.5 mm or greater than 4.0 mm.
  • Subject has one or more lesion planned to be treated with a stent/scaffold length greater than 70 mm and/or overlapping of four or more scaffolds/stents.
  • Subject has known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel and ticagrelor, inclusive), everolimus, poly (L-lactide), poly (DL-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
  • Subjects pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. (Female subjects of child-bearing potential must have a negative pregnancy test done within 28 days prior to the index procedure and contraception must be used during participation in this trial)
  • Subjects with a limited life expectancy less than one year.
  • Subjects with factors that impede clinical follow-up (e.g. no fixed abode).
  • Subject is already participating in another clinical investigation that has not yet reached its primary endpoint.
  • Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff or sponsor staff) or subject unable to read or write.

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:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:ABSORB BVS™
Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System
Bioresorbable scaffold
其他名称:
  • 吸收 BVS
  • BVS
  • 吸收
  • ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold
有源比较器:XIENCE™
XIENCE PRIME everolimus eluting coronary stent system and the XIENCE Xpedition everolimus eluting coronary stent system
Drug eluting metallic stent
其他名称:
  • DES
  • XIENCE 总理
  • XIENCE远征队
  • 西恩斯
  • Drug eluting stent

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
Target Vessel Failure (TVF)
大体时间:2 years

The primary composite endpoint is the device-oriented composite of target vessel failure (TVF):

  • Cardiac death
  • Myocardial Infarction (MI) (unless clearly attributable to a non target vessel)
  • Target vessel revascularization
2 years

次要结果测量

结果测量
措施说明
大体时间
Device success
大体时间:1 day
Successful delivery and deployment of the first study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 20% by quantitative coronary angiography (QCA) and thrombolysis in myocardial infarction (TIMI) 3 flow grade of the treated vessel.
1 day
Procedural success
大体时间:1 day
Achievement of final in-scaffold/stent residual stenosis of less than 20% by QCA and TIMI 3 flow grade of the treated vessel with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat Target Lesion Revascularization during the hospital stay.
1 day
Target vessel failure (TVF)
大体时间:30 days, and 1, 3, 4 and 5 years
Cardiac death, MI (not clearly attributable to a nontarget vessel) or target vessel revascularization
30 days, and 1, 3, 4 and 5 years
Target lesion failure
大体时间:30 days, and 1, 2, 3, 4 and 5 years
Cardiac death, MI (not clearly attributable to a nontarget vessel) or target lesion revascularization
30 days, and 1, 2, 3, 4 and 5 years
All revascularizations
大体时间:5 year
5 year
Major adverse cardiac events
大体时间:30 days, and 1, 2, 3, 4 and 5 years
All-cause mortality, any MI, any repeat revascularization
30 days, and 1, 2, 3, 4 and 5 years
All cause mortality
大体时间:30 days, 1 year, 2, 3, 4 and 5 years
30 days, 1 year, 2, 3, 4 and 5 years
Myocardial Infarction
大体时间:30 days, 1, 2, 3, 4 and 5 years
Q-wave Myocardial Infarction (QMI) and non Q-wave Myocardial Infarction (nonQMI)/target-vessel myocardial infarction (TVMI) and non-TVMI
30 days, 1, 2, 3, 4 and 5 years
Target Lesion Revascularization (TLR)
大体时间:30 days, 1 year, 2, 3, 4 and 5 years
30 days, 1 year, 2, 3, 4 and 5 years
Target Vessel Revascularization (TVR)
大体时间:30 days, 1 year, 2, 3, 4 and 5 years
30 days, 1 year, 2, 3, 4 and 5 years
Non-Target Vessel Revascularization (NTVR)
大体时间:30 days, 1 year, 2, 3, 4 and 5 years
30 days, 1 year, 2, 3, 4 and 5 years
Scaffold/Stent Thrombosis
大体时间:30 days, 1, 2, 3, 4 and 5 years
acute, subacute, late/definite and probable
30 days, 1, 2, 3, 4 and 5 years
Seattle Angina Questionnaire (SAQ)
大体时间:1 year and 2 years
1 year and 2 years
Quality of Life Questionnaire (QOL)
大体时间:1 year and 2 years
1 year and 2 years

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。

调查人员

  • 研究主任:Joanna Wykrzykowska, MD, PhD、Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • 首席研究员:Rob de Winter, MD, PhD、Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • 首席研究员:Jan Piek, MD, PhD、Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • 首席研究员:Jan Tijssen, PhD、Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • 首席研究员:Jose Henriques, MD, PhD、Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2013年8月1日

初级完成 (实际的)

2017年12月1日

研究完成 (预期的)

2020年12月1日

研究注册日期

首次提交

2013年5月10日

首先提交符合 QC 标准的

2013年5月16日

首次发布 (估计)

2013年5月21日

研究记录更新

最后更新发布 (实际的)

2019年1月9日

上次提交的符合 QC 标准的更新

2019年1月8日

最后验证

2019年1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.

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