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Feasibility Trial Evaluating Efficacy and Safety of Solitaire™ Thrombus Retrieval Device in the Management of Refractory Thrombus in Patients With Acute Coronary Syndrome (Solitaire)

2020年12月29日 更新者：Paul Ong
The study is designed as a multicentre open label prospective feasibility trial to capture preliminary efficacy and safety information on Solitaire device to plan an appropriate pivotal study.

研究概览

地位

未知

条件

干预/治疗

详细说明

We hypothesize that Solitaire device could be effectively and safely used as an adjunctive interventional technique in ACS patients found to have refractory thrombus during PCI.

  1. Primary Objectives To evaluate intra-procedure efficacy of using Solitaire in ACS patients with refractory thrombus.
  2. Secondary Objectives To evaluate clinical efficacy of using Solitaire in ACS patients with refractory thrombus, up to one year post-procedure.

To evaluate safety of using Solitaire in ACS patients with refractory thrombus.

The target enrolment is 51 patients diagnosed with STEMI, NSTEMI or UA and found to have refractory thrombus during PCI. Eligible patients will be identified at the ED or Inpatient ward of the 5 participating hospitals. The projected enrolment period is for two years and follow up for one year. A screening log will be maintained at each site to keep record of patients who were eligible for the study but not enrolled, to establish any selection bias.

研究类型

介入性

注册 (预期的)

51

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

  • 新加坡
      • Singapore、新加坡、768828
        • 招聘中
        • Khoo Teck Puat Hospital
        • 接触：
        • 首席研究员：
          • Dr Syed Saqib Imran
      • Singapore、新加坡、119074
        • 招聘中
        • National University Heart Centre Singapore (NUHCS)
        • 接触：
        • 首席研究员：
          • Dr Joshua LOH
      • Singapore、新加坡、308433
        • 招聘中
        • Tan Tock Seng Hospital (TTSH)
        • 接触：
        • 首席研究员：
          • Dr Paul Jau Lueng Ong
      • Singapore、新加坡、529889
        • 招聘中
        • Changi General Hospital (CGH) Changi General Hospital
        • 接触：
        • 首席研究员：
          • Dr Yew Seong Goh
    • Singaproe
      • Singapore、Singaproe、新加坡、169609
        • 招聘中
        • National Heart Centre Singapore (NHCS)
        • 接触：
        • 首席研究员：
          • Dr Aaron Sung Lung Wong

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

22年 至 80年 (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:

Subjects meeting all of the inclusion criteria listed below will be included in this study:

  1. Index event of ST segment elevation or non-ST segment elevation MI or Unstable Angina defined as:

    1. Presentation to hospital with symptoms of myocardial ischemia (Chest pain or angina equivalent) lasting for ≥10 minutes at rest

      AND 1 of the following:

    2. Persistent ST segment elevation ≥1mm (0.1 mV) in two or more contiguous limb leads or ≥2mm (0.2 mV) in ) in one or more contiguous precordial leads OR
    3. New or presumed new left bundle branch block (LBBB) OR
    4. ST segment depression ≥1mm (0.1 mV) in two or more contiguous leads (not known to be pre-existing or due to a known cause such as LV hypertrophy or digoxin) OR
    5. Troponin T or I greater than the laboratory upper normal limit.

  2. Referred for urgent or emergency PCI AND Thrombus burden of TG 4 or above OR TIMI flow grade of 1 or less in at least one native infarct related artery following either

    1. Manual aspiration thrombectomy OR
    2. Balloon Angioplasty OR
    3. AngioJet RT OR
    4. Patient having deferred PCI due to heavy thrombus but continue to demonstrate recalcitrant thrombus upon repeat angiography.

Exclusion Criteria:

Subjects meeting any of the exclusion criteria listed below will be excluded from this study:

  1. Age ≤ 21 years
  2. Cardiogenic shock
  3. killip class 3 or above at presentation

  4. Known relative contraindications for the use of Solitaire:

    1. Prior stent in infarct related artery
    2. Significant proximal stenosis OR Ostial lesion at angiography
    3. Extensive calcification
  5. Life expectancy less than six months due to non-cardiac condition
  6. Participants categorised as vulnerable subjects (ex: prisoners, pregnant women, and mentally disabled persons)
  7. Patients at high risk of being lost to follow up (ex: non-residents)
  8. Participation in any study with an investigational drug or device within the last 30 days
  9. Patients who are unable to provide informed consent prior to any procedure .

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：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
其他：open label
open label prospective feasibility trial.
设备：Solitaire™ thrombus retrieval device
After consent has been obtained, interventional cardiologist selects the proper solitaire device size per device-specific instructions for use. Adjunctive intervention with Solitaire will be done with a maximum of 2 device deployments. Do not perform more than three recovery attempts in the same vessel using the devices (Maximum of 2 attempts per device per subject). Do not reposition each device more than two times. TIMI flow, thrombus grade and myocardial blush grade will be assessed immediately upon completion of procedure. If recanalization is deemed inadequate by the interventional cardiologist, rescue treatment will follow as per current clinical practice. All other procedures followed will be as clinically indicated.

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
Rate of successful recanalization defined as an immediate post-procedure Thrombolysis in Myocardial Infarction (TIMI) flow of 2 or 3.
大体时间：immediate post-procedure
Primary Efficacy Endpoint
immediate post-procedure
Occurrence of any stroke
大体时间：immediate post-procedure up to 30 days
Occurrence of any stroke, defined as the presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours, from immediate post-procedure up to 30 days.
immediate post-procedure up to 30 days
Incidence of study device-related Serious Adverse Events (SAEs) up to 30 days.
大体时间：up to 30 days
Primary Safety Endpoint
up to 30 days
Incidence of emboli in new territory (ENT) at 24 hrs ± 8 hrs post procedure (ENT: Embolization territories outside of the target downstream territory).
大体时间：at 24 hours ± 8 hours post procedure
Primary Safety Endpoint
at 24 hours ± 8 hours post procedure

次要结果测量

结果测量
措施说明
大体时间
Rate of successful thrombus resolution defined as an immediate post-procedure thrombus burden of thrombus grade (TG) 1 or less
大体时间：immediate post-procedure
Secondary Endpoints
immediate post-procedure
Rate of successful recanalization defined as a reduction in corrected TIMI frame count after use of the Solitaire device.
大体时间：immediate post-procedure
Secondary Endpoints
immediate post-procedure
Rate of successful myocardial perfusion defined as an immediate post-procedure myocardial blush grade (MBG) of 2 or more
大体时间：immediate post-procedure
Secondary Endpoints
immediate post-procedure
Rate of device success defined as successful delivery and retrieval of the device without complication
大体时间：immediate post- procedure
Secondary Endpoints
immediate post- procedure
Occurrence of major adverse cardiac and cerebrovascular events (MACCE)
大体时间：up to one year post-procedure
Occurrence of major adverse cardiac and cerebrovascular events (MACCE), defined as composite of all cause death, myocardial infarction, target vessel revascularisation or stroke, up to one year post-procedure.
up to one year post-procedure
All-cause mortality through 90 days post procedure.
大体时间：90 days post procedure
Secondary Endpoints
90 days post procedure

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

Paul Ong

调查人员

  • 首席研究员：Paul Jau Lueng Ong、Paul Ong Jau Lueng

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7月16日

初级完成 (预期的)

2022年6月30日

研究完成 (预期的)

2022年9月30日

研究注册日期

首次提交

2020年10月28日

首先提交符合 QC 标准的

2020年12月29日

首次发布 (实际的)

2020年12月31日

研究记录更新

最后更新发布 (实际的)

2020年12月31日

上次提交的符合 QC 标准的更新

2020年12月29日

最后验证

2020年12月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • DSRB 2018/00865

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

是的

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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