CAlcified Lesion Intervention Planning Steered by OCT.

Study Overview
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Brief Summary
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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.

Official Title
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CAlcified Lesion Intervention Planning Steered by OCT.

Conditions
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Coronary Artery Calcification, Angioplasty

Intervention / Treatment
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* Procedure: angioplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: angiography-guided group<br>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. | Procedure: angioplasty<br>* 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<br>|
| Experimental: OCT-guided group<br>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. | Procedure: angioplasty<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of the CALIPSO study is the minimal stent area (MSA) on the final OCT run | 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). | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometrical stent expansion (%) according to the DOCTORS or LEMON criteria | After the stent is deployed, the blood flow dynamics influence the mechanics by compressing and expanding the structure. | during procedure | 
| Residual post PCI (Percutaneous Coronary Intervention)stenosis (assessed by QCA methods) | Qualitative Comparative Analysis (QCA) is a methodology that enables the analysis of multiple cases in complex situations | during procedure | 
| Residual major struts malapposition: crude incidence and quantification | 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. | during procedure | 
| Major adverse cardiovascular events at 30 days and 1 year | Cardiovascular death + Any myocardial infarction + need for re-intervention on the target lesion (TLR) | at 30 days and 1 year | 
| Peri-procedural MI according to the SCAI definition (23) | according to the SCAI definition (Moussa et al., Journal of the American College of Cardiology 2013) | during procedure | 
| Coronary artery perforation: incidence | Coronary perforation was defined as evidence of extravasation of dye or blood from the coronary artery during or following the interventional procedure | during the procedure and During the full participation period (1 year).] | 
| Radiation dose | Differences in dose radiation used during le procedure | during procedure | 
| Total Contrast medium volume | Differences in amount of contrast drug used during le procedure | during procedure | 
| Procedure duration | differences in duration (time) of the procedure | 24th post-operative hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Optical Coherence Tomography, OCT, minimal stent area(MSA)