CAlcified Lesion Intervention Planning Steered by OCT.

Institut Mutualiste Montsouris140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Coronary Artery Calcification Angioplasty

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (14)

Ch de Bastia

Bastia, France

RECRUITING

CHU de Besançon

Besançon, France

RECRUITING

CHU de Bordeaux

Bordeaux, France

RECRUITING

Clinique Saint Augustin

Bordeaux, France

RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

Hôpital Louis Pasteur

Le Coudray, France

RECRUITING

L'Hôpital Privé du Confluent

Nantes, France

RECRUITING

CHU Nîmes

Nîmes, France

RECRUITING

Polyclinique les Fleurs

Ollioules, France

RECRUITING

CHU de Poitiers

Poitiers, France

RECRUITING

...and 4 more locations

Outcomes

Primary Outcomes

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).

Time frame: During the procedure

Secondary Outcomes

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.

Time frame: 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

Time frame: 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.

Time 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)

Time frame: 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)

Time frame: 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

Time frame: during the procedure and During the full participation period (1 year).]

Radiation dose

Differences in dose radiation used during le procedure

Time frame: during procedure

Total Contrast medium volume

Differences in amount of contrast drug used during le procedure

Time frame: during procedure

Procedure duration

differences in duration (time) of the procedure

Time frame: 24th post-operative hour

CAlcified Lesion Intervention Planning Steered by OCT.

Overview

Conditions

Interventions

Eligibility

Locations (14)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts