CAlcified Lesion Intervention Planning Steered by OCT.
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 14
- 主要终点
- The primary endpoint of the CALIPSO study is the minimal stent area (MSA) on the final OCT run
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Age < 18 y
- •Denial to provide consent
研究组 & 干预措施
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.
干预措施: angioplasty (Procedure)
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.
干预措施: angioplasty (Procedure)
结局指标
主要结局
The primary endpoint of the CALIPSO study is the minimal stent area (MSA) on the final OCT run
时间窗: During the procedure
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).
次要结局
- Geometrical stent expansion (%) according to the DOCTORS or LEMON criteria(during procedure)
- Residual post PCI (Percutaneous Coronary Intervention)stenosis (assessed by QCA methods)(during procedure)
- Coronary artery perforation: incidence(during the procedure and During the full participation period (1 year).])
- Major adverse cardiovascular events at 30 days and 1 year(at 30 days and 1 year)
- Radiation dose(during procedure)
- Total Contrast medium volume(during procedure)
- Procedure duration(24th post-operative hour)
- Residual major struts malapposition: crude incidence and quantification(during procedure)
- Peri-procedural MI according to the SCAI definition (23)(during procedure)