WEDGES: Coronary Lesion Preparation With Enhanced Dilatation for Good Expansion of Stent: Assessment of a New Scoring Balloon by Quantitative Stent Enhanced Visualization (WEDGES)
2021年8月18日 更新者：Stephane Carlier
WEDGES: a Prospective, Multi-center Randomized Trial for the Evaluation of Coronary Lesion Preparation With Enhanced Dilatation for Good Expansion of Stent: Assessment of a New Scoring Balloon by Quantitative Stent Enhanced Visualization
Stent under-expansion during percutaneous coronary intervention (PCI) is one of the suboptimal results associated with a higher risk of restenosis and thrombosis. In order to obtain an optimal stent expansion, especially in lesions with calcific or fibrotic plaque, the appropriate lesion preparation before stent implantation is a crucial phase.
For this, different devices are used in everyday practices, including non-compliant balloon (NC), scoring / cutting balloons or rotational atherectomy; however, their effectiveness depends on the experience and skill of the operator. The purpose of this study is to assess the feasibility, efficacy and safety of a novel scoring balloon intended to treat calcific or fibrotic plaque of a coronary lesion
研究概览
研究类型
介入性
注册 (预期的)
100
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。
学习联系方式
- 姓名：Stéphane Carlier
- 电话号码：0032475812765
- 邮箱：stephane.carlier@umons.ac.be
研究联系人备份
- 姓名：Chadi Ghafari
- 邮箱：chadi.ghafari@umons.ac.be
学习地点
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Genk、比利时、3600
- 招聘中
- UZ Genk
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接触：
- Jo Dens
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Ghent、比利时、9000
- 招聘中
- UZ Ghent
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接触：
- Peter Kayaert
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La Louvière、比利时、7100
- 招聘中
- CHU Jolimont
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接触：
- Claudiu Ungureanu
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Liège、比利时、4000
- 招聘中
- CHU Liège
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接触：
- Lancelotti
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Mons、比利时、7000
- 招聘中
- CHU Ambroise Paré
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接触：
- Stéphane Carlier
- 邮箱：stephane.carlier@umons.ac.be
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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
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patient written consent is given A de novo lesion
- Mild to moderate burden of calcifications detected on two orthogonal views using normal radiation power
Exclusion Criteria:
Exclusion criteria patient-related:
- Patient <18 years old
- Pregnant female
- Contraindication to dual antiplatelet therapy
- Thrombocytopenia <100 000
- Major surgical intervention planned
Exclusion criteria lesion-related:
- Significant left main lesion
- Bifurcating lesion with a significant side branch to be treated
- Lesion length > 25 mm
- Chronic total occlusion
- Lesion with heavy calcifications where a rotational atherectomy or lithotripsy should be planned
- Lesion in a graft
- In-stent restenosis lesion
- Lesion responsible of a STEMI
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 |
|---|---|
|
有源比较器：Conventional balloon predilation
the target lesion can be prepared according to standard clinical practice using SC balloons sized 0.8-1:1.
Stenting using a drug-eluting stent (DES) is performed and the inflation pressure for delivery is noted, as well as the expected balloon diameter at that pressure.
2 enhanced stent imaging acquisitions (StentBoost or equivalent depending on the X-ray system used), are acquired in 2 orthogonal views.
Post dilatation can be performed at operator discretion followed by a final acquisition of 2 similar orthogonal views with enhanced stent imaging.
Intravascular imaging is left to the operator's discretion and is encouraged
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Conventional balloon
|
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实验性的：Scoring balloon predilation
the target lesion must be prepared with a scoring balloon (SC) inflated 3 times at nominal pressure.
To allow the scoring balloon to cross the lesion, it might be necessary to predilate with a small compliant balloon.
The size of the scoring balloon to be used for is based on the size of the vessel.
Stenting using a DES is performed and the inflation pressure for delivery is noted, as well as the expected balloon diameter at that pressure.
2 enhanced stent imaging acquisitions (StentBoost or equivalent depending on the X-ray system used), are acquired in 2 orthogonal views.
Post dilatation can be performed at operator discretion followed by a final acquisition of 2 similar orthogonal views with enhanced stent imaging.
Intravascular imaging is left to the operator's discretion and is encouraged
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Scoring balloon
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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 |
|---|---|---|
|
Stent expansion in calcified lesions assessed by stent diameter calculation using quantitative and intravascular analysis after lesion preparation using a scoring balloon is superior to conventional lesion preparation
大体时间：Intravascular ultrasound (IVUS) or quantitative analysis is directly done after procedure
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The measure of stent expansion in calcified coronary lesions as assessed by quantitative coronary angiography, enhanced stent imaging and intravascular ultrasound after lesion preparation using the novel scoring semi-compliant and noncompliant balloons are superior (p<0.05) to semi compliant and non-compliant balloons.
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Intravascular ultrasound (IVUS) or quantitative analysis is directly done after procedure
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Rate of successful predilatation of calcified lesions of a scoring semi-compliant/non-compliant balloon and semi-compliant (SC)/ non-compliant (NC) balloon
大体时间：Directly after procedure
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Directly after procedure
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Rate of residual under-expansion of stent after post-dilatation with a non-compliant balloon
大体时间：Directly after procedure
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Directly after procedure
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Rate of procedural complication (composite of cardiac death, myocardial infarction, coronary artery perforation and cardiac tamponade) of a scoring balloon and a SC/NC balloon followed by stenting.
大体时间：1 month follow up
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1 month follow up
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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。
调查人员
- 研究主任：Stéphane Carlier、University of Mons
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)
2020年1月1日
初级完成 (预期的)
2022年7月30日
研究完成 (预期的)
2022年10月30日
研究注册日期
首次提交
2021年8月13日
首先提交符合 QC 标准的
2021年8月18日
首次发布 (实际的)
2021年8月24日
研究记录更新
最后更新发布 (实际的)
2021年8月24日
上次提交的符合 QC 标准的更新
2021年8月18日
最后验证
2021年8月1日
更多信息
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