CAlcified Lesion Intervention Planning Steered by OCT. (CALIPSO)

Institut Mutualiste Montsouris

Status: Unknown

Conditions: Angioplasty; Coronary Artery Calcification

Treatments: Procedure: angioplasty

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05301218

CARDIO 04 2021

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

angiography-guided group

Active Comparator group

Description:

the treatment (including lesion preparation, stent sizing and post implantation optimization) will be performed by angiography. Once the result is considered optimal by the operator, a control OCT run will be acquired.

Treatment:

Procedure: angioplasty

OCT-guided group

Experimental group

Description:

a preliminary OCT run will be recorded. An initial predilation with 1.5 to 2.0 mm balloon could be accepted in order to facilitate OCT catheter delivery through the target lesion. The PCI strategy will be guided by a pre-defined algorithm based on initial OCT findings. Post PCI result will be assessed by control OCT and potential optimization steps could be applied according to the results. The MLD-MAX optimization approach will be applied. Final OCT run will be performed at the end of the procedure.

Treatment:

Procedure: angioplasty