CAlcified Lesion Intervention Planning Steered by OCT. (CALIPSO)
2022年11月14日 更新者：Institut Mutualiste Montsouris
Calcified lesions are very frequent among coronary artery disease stenotic lesions.
The prevalence of calcifications ranges from 30 to 40% (by angiography evaluation) but is higher when analyzed by intra coronary imaging.
Calcified lesions are very frequent among coronary artery disease stenotic lesions. The prevalence of calcifications ranges from 30 to 40% (by angiography evaluation) but is higher when analyzed by intra coronary imaging.
The presence of calcifications increases the risk of adverse evolution after PCI , including stent restenosis, thrombosis and need for repeat revascularisation. Specific and appropriate tools can be used for calcified lesions management , including high pressure non compliant balloons, intravascular lithotripsy and rotablator. Intra vascular OCT has a high sensitivity and specificity for calcium detection among coronary artery lesions. Compared to IVUS, OCT allows a better quantification of calcium sheets (depth extension ) . Several intra coronary imaging based calcified lesions management algorithms have been proposed , but none have been validated in clinical practice.
研究概览
研究类型
介入性
注册 (预期的)
140
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：Nicolas Amabile, MD PhD
- 电话号码：33 0156616983
- 邮箱：nicolas.amabile@imm.fr
研究联系人备份
- 姓名：Silvia Burbassi, PhD
- 电话号码：33 0156616983
- 邮箱：silvia.burbassi@imm.fr
学习地点
-
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Bastia、法国、20600
- 招聘中
- CH de Bastia
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接触：
- Ziad Boueri, MD
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Besançon、法国、25000
- 招聘中
- CHu de Besançon
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接触：
- Nicolas Meneveau, MD
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Bordeaux、法国、33000
- 招聘中
- Chu de Bordeaux
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接触：
- Benjamin Séguy, MD
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Bordeaux、法国、33200
- 招聘中
- Clinique Saint Augustin
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接触：
- Frederic Casassus, MD
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Clermont-Ferrand、法国、63000
- 招聘中
- CHU de Clermont-Ferrand
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接触：
- Géraud SOUTEYRAND, MD
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Le Coudray、法国、28630
- 招聘中
- Hôpital Louis Pasteur
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接触：
- Grégoire RANGé Rangé, MD
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Nantes、法国、44000
- 招聘中
- L'Hôpital privé du Confluent
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接触：
- Erwan BRESSOLLETTE, MD
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Nîmes、法国、30029
- 招聘中
- CHU Nîmes
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接触：
- Guillaume Cayla, MD
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Ollioules、法国、83190
- 招聘中
- Polyclinique Les Fleurs
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接触：
- Philippe Commeau, MD
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Poitiers、法国、86000
- 招聘中
- CHU de Poitiers
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接触：
- Sébastien Levesque, MD
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Rouen、法国、76000
- 招聘中
- Clinique Saint-Hilaire
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接触：
- Quentin LANDOLFF, MD
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Saint-Laurent-du-Var、法国、06700
- 招聘中
- Institut Arnaud Tzanck,
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接触：
- Julien ADJEDJ, MD
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Toulouse、法国、31300
- 招聘中
- Clinique Pasteur
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接触：
- Benjamin HONTON, MD
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Ile De France
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Paris、Ile De France、法国、75014
- 招聘中
- Institut Mutualiste Montsouris
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接触：
- Silvia Burbassi, PhD
- 电话号码：33 0156616983
- 邮箱：silvia.burbassi@imm.fr
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首席研究员：
- Nicolas Amabile, MD PhD
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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 至 100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:
- Patient with chronic coronary syndrome
Angiographically moderately to severely calcified target lesion, defined as follows:
- Moderate: lesion with radio-opacities noted only during the cardiac cycle before contrast dye injection (Aksoy et al., Circ Cardiovasc Interv 2019)
- Severe: lesion with radio-opacities seen without cardiac motion before contrast dye injection, visible on both sides of the arterial lumen(Aksoy et al., Circ Cardiovasc Interv 2019)
- Possibility to cross the target lesion with OCT catheter
Exclusion Criteria:
- On-going cardiogenic shock
- Acute coronary syndrome related to target lesion
- Severe renal failure (Creatinine clearance: 30 ml/min/m2)
- Impossibility to cross target lesion with OCT catheter & balloons,
- Indication for Rotablator device as first line therapy
- Pregnancy
- Age < 18 y
- Denial to provide consent
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 |
|---|---|
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有源比较器：angiography-guided group
the treatment (including lesion preparation, stent sizing and post implantation optimization) will be performed by angiography.
Once the result is considered optimal by the operator, a control OCT run will be acquired.
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Coronary angioplasty, also called percutaneous coronary intervention, is a procedure used to open clogged heart arteries.
Angioplasty uses a tiny balloon catheter that is inserted in a blocked blood vessel to help widen it and improve blood flow to the heart
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实验性的：OCT-guided group
a preliminary OCT run will be recorded.
An initial predilation with 1.5 to 2.0 mm balloon could be accepted in order to facilitate OCT catheter delivery through the target lesion.
The PCI strategy will be guided by a pre-defined algorithm based on initial OCT findings.
Post PCI result will be assessed by control OCT and potential optimization steps could be applied according to the results.
The MLD-MAX optimization approach will be applied.
Final OCT run will be performed at the end of the procedure.
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Coronary angioplasty, also called percutaneous coronary intervention, is a procedure used to open clogged heart arteries.
Angioplasty uses a tiny balloon catheter that is inserted in a blocked blood vessel to help widen it and improve blood flow to the heart
|
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 |
|---|---|---|
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The primary endpoint of the CALIPSO study is the minimal stent area (MSA) on the final OCT run
大体时间：During the procedure
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The crude minimal stent area (MSA) will be measured along the stent on the target lesion.
Stent geometric expansion will be evaluated by the DOCTORS criteria for non-bifurcated segments (Meneveau et, Circulation 2016) and LEMON criteria for bifurcated segments (Amabile et al;, Eurointervention 2020).
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During the procedure
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Geometrical stent expansion (%) according to the DOCTORS or LEMON criteria
大体时间：during procedure
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After the stent is deployed, the blood flow dynamics influence the mechanics by compressing and expanding the structure.
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during procedure
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Residual post PCI (Percutaneous Coronary Intervention)stenosis (assessed by QCA methods)
大体时间：during procedure
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Qualitative Comparative Analysis (QCA) is a methodology that enables the analysis of multiple cases in complex situations
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during procedure
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Residual major struts malapposition: crude incidence and quantification
大体时间：during procedure
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malapposition was defined as a lack of contact of at least 1 strut with the underlying vessel wall (at least 150 μm, in the absence of a side branch) with evidence of blood flow behind the strut.
It was classified as "major" malapposition if there was evidence of at least 30% of the struts in one frame.
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during procedure
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Major adverse cardiovascular events at 30 days and 1 year
大体时间：at 30 days and 1 year
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Cardiovascular death + Any myocardial infarction + need for re-intervention on the target lesion (TLR)
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at 30 days and 1 year
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Peri-procedural MI according to the SCAI definition (23)
大体时间：during procedure
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according to the SCAI definition (Moussa et al., Journal of the American College of Cardiology 2013)
|
during procedure
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Coronary artery perforation: incidence
大体时间：during the procedure and During the full participation period (1 year).]
|
Coronary perforation was defined as evidence of extravasation of dye or blood from the coronary artery during or following the interventional procedure
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during the procedure and During the full participation period (1 year).]
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Radiation dose
大体时间：during procedure
|
Differences in dose radiation used during le procedure
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during procedure
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Total Contrast medium volume
大体时间：during procedure
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Differences in amount of contrast drug used during le procedure
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during procedure
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Procedure duration
大体时间：24th post-operative hour
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differences in duration (time) of the procedure
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24th post-operative hour
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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。
合作者
调查人员
- 首席研究员：Nicolas Amabile, MD PhD、Institut Mutualiste Montsouris
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12月15日
初级完成 (预期的)
2023年12月15日
研究完成 (预期的)
2023年12月15日
研究注册日期
首次提交
2022年3月8日
首先提交符合 QC 标准的
2022年3月17日
首次发布 (实际的)
2022年3月29日
研究记录更新
最后更新发布 (实际的)
2022年11月15日
上次提交的符合 QC 标准的更新
2022年11月14日
最后验证
2022年4月1日
更多信息
与本研究相关的术语
其他研究编号
- CARDIO 04 2021
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