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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05301218
Other study ID # CARDIO 04 2021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 15, 2021
Est. completion date December 15, 2023

Study information

Verified date April 2022
Source Institut Mutualiste Montsouris
Contact Nicolas Amabile, MD PhD
Phone 0156616983
Email nicolas.amabile@imm.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date December 15, 2023
Est. primary completion date December 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
angioplasty
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

Locations

Country Name City State
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 Institut Mutualiste montsouris Paris Ile De France
France CHU de Poitiers Poitiers
France Clinique Saint-Hilaire Rouen
France Institut Arnaud Tzanck, Saint-Laurent-du-Var
France Clinique Pasteur Toulouse

Sponsors (2)

Lead Sponsor Collaborator
Institut Mutualiste Montsouris Abbott

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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).]
Secondary Radiation dose Differences in dose radiation used during le procedure during procedure
Secondary Total Contrast medium volume Differences in amount of contrast drug used during le procedure during procedure
Secondary Procedure duration differences in duration (time) of the procedure 24th post-operative hour
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