CAlcified Lesion Intervention Planning Steered by OCT.

Coronary Artery Calcification Clinical Trial

— CALIPSO  

Official title:

CAlcified Lesion Intervention Planning Steered by OCT.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05301218
• Other study ID #: CARDIO 04 2021
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Angioplasty
• Calcinosis
• Coronary Artery Calcification

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