Clinical trial NCT05301218: CAlcified Lesion Intervention Planning Steered by OCT.
Official title: CAlcified Lesion Intervention Planning Steered by OCT.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Calcification
Angioplasty
Keywords: Optical Coherence Tomography, OCT
minimal stent area(MSA)
Lead sponsor: Institut Mutualiste Montsouris
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2022-03-29
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The primary endpoint of the CALIPSO study is the minimal stent area (MSA) on the final OCT run
timeFrame: During the procedure
Secondary outcomes:
measure: Geometrical stent expansion (%) according to the DOCTORS or LEMON criteria
timeFrame: during procedure
measure: Residual post PCI (Percutaneous Coronary Intervention)stenosis (assessed by QCA methods)
timeFrame: during procedure
measure: Residual major struts malapposition: crude incidence and quantification
timeFrame: during procedure
measure: Major adverse cardiovascular events at 30 days and 1 year
timeFrame: at 30 days and 1 year
measure: Peri-procedural MI according to the SCAI definition (23)
timeFrame: during procedure
measure: Coronary artery perforation: incidence
timeFrame: during the procedure and During the full participation period (1 year).]
measure: Radiation dose
timeFrame: during procedure
measure: Total Contrast medium volume
timeFrame: during procedure
measure: Procedure duration
timeFrame: 24th post-operative hour
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Mutualiste montsouris
state: Ile De France
city: Bastia
country: France
facility: Ch de Bastia
city: Besançon
country: France
facility: CHU de Besançon
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Bordeaux
country: France
facility: Clinique Saint Augustin
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Le Coudray
country: France
facility: Hôpital Louis Pasteur
city: Nantes
country: France
facility: L'Hôpital Privé du Confluent
city: Nîmes
country: France
facility: CHU Nîmes
city: Ollioules
country: France
facility: Polyclinique les Fleurs
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rouen
country: France
facility: Clinique Saint-Hilaire
city: Saint-Laurent-du-Var
country: France
facility: Institut Arnaud Tzanck,
city: Toulouse
country: France
facility: Clinique Pasteur
Study officials:
affiliation: Institut Mutualiste Montsouris
name: Nicolas Amabile, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: