CAlcified Lesion Intervention Planning Steered by OCT.
- Conditions
- AngioplastyCoronary Artery Calcification
- Interventions
- Procedure: angioplasty
- Registration Number
- NCT05301218
- Lead Sponsor
- Institut Mutualiste Montsouris
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 140
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OCT-guided group angioplasty 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. angiography-guided group angioplasty 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.
- Primary Outcome Measures
Name Time Method The primary endpoint of the CALIPSO study is the minimal stent area (MSA) on the final OCT run 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).
- Secondary Outcome Measures
Name Time Method Geometrical stent expansion (%) according to the DOCTORS or LEMON criteria during procedure After the stent is deployed, the blood flow dynamics influence the mechanics by compressing and expanding the structure.
Residual post PCI (Percutaneous Coronary Intervention)stenosis (assessed by QCA methods) during procedure Qualitative Comparative Analysis (QCA) is a methodology that enables the analysis of multiple cases in complex situations
Coronary artery perforation: incidence 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
Major adverse cardiovascular events at 30 days and 1 year at 30 days and 1 year Cardiovascular death + Any myocardial infarction + need for re-intervention on the target lesion (TLR)
Radiation dose during procedure Differences in dose radiation used during le procedure
Total Contrast medium volume during procedure Differences in amount of contrast drug used during le procedure
Procedure duration 24th post-operative hour differences in duration (time) of the procedure
Residual major struts malapposition: crude incidence and quantification during procedure 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.
Peri-procedural MI according to the SCAI definition (23) during procedure according to the SCAI definition (Moussa et al., Journal of the American College of Cardiology 2013)
Trial Locations
- Locations (14)
Ch de Bastia
🇫🇷Bastia, France
Institut Mutualiste montsouris
🇫🇷Paris, Ile De France, France
CHU de Besançon
🇫🇷Besançon, France
CHU de Bordeaux
🇫🇷Bordeaux, France
CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
Clinique Saint Augustin
🇫🇷Bordeaux, France
Hôpital Louis Pasteur
🇫🇷Le Coudray, France
Polyclinique les Fleurs
🇫🇷Ollioules, France
CHU Nîmes
🇫🇷Nîmes, France
CHU de Poitiers
🇫🇷Poitiers, France
L'Hôpital Privé du Confluent
🇫🇷Nantes, France
Clinique Saint-Hilaire
🇫🇷Rouen, France
Clinique Pasteur
🇫🇷Toulouse, France
Institut Arnaud Tzanck,
🇫🇷Saint-Laurent-du-Var, France