CAlcified Lesion Intervention Planning Steered by OCT.

Not Applicable

• Conditions: Angioplasty; Coronary Artery Calcification

• 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

Study Timeline

• Study Start: 2021-12-15
• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-29
• Status Verified: 2022-04
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-15
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Patient with chronic coronary syndrome

2. 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)

3. Possibility to cross the target lesion with OCT catheter

Exclusion Criteria

1. On-going cardiogenic shock
2. Acute coronary syndrome related to target lesion
3. Severe renal failure (Creatinine clearance: 30 ml/min/m2)
4. Impossibility to cross target lesion with OCT catheter & balloons,
5. Indication for Rotablator device as first line therapy
6. Pregnancy
7. Age < 18 y
8. Denial to provide consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

Institut Mutualiste montsouris; 🇫🇷 Paris, Ile De France, France

Ch de Bastia; 🇫🇷 Bastia, France

CHU de Besançon; 🇫🇷 Besançon, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

Clinique Saint Augustin; 🇫🇷 Bordeaux, France

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Hôpital Louis Pasteur; 🇫🇷 Le Coudray, France

L'Hôpital Privé du Confluent; 🇫🇷 Nantes, France

CHU Nîmes; 🇫🇷 Nîmes, France

Polyclinique les Fleurs; 🇫🇷 Ollioules, France

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