CAlcified Lesion Intervention Planning Steered by OCT.

NCT05301218 | Unknown

• 1 other identifier: CARDIO 04 2021
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 14

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.

Conditions

Coronary Artery Calcification; Angioplasty

Keywords

Optical Coherence Tomography, OCT; minimal stent area(MSA)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Geometrical stent expansion (%) according to the DOCTORS or LEMON criteria

  during procedure

• Residual post PCI (Percutaneous Coronary Intervention)stenosis (assessed by QCA methods)

  during procedure

• Residual major struts malapposition: crude incidence and quantification

  during procedure

• Major adverse cardiovascular events at 30 days and 1 year

  at 30 days and 1 year

• Peri-procedural MI according to the SCAI definition (23)

  during procedure

Study Arms (2)

angiography-guided group

ACTIVE COMPARATOR

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.

Procedure: angioplasty

OCT-guided group

EXPERIMENTAL

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.

Procedure: angioplasty

Interventions

angioplasty PROCEDURE

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

OCT-guided group; angiography-guided group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with chronic coronary syndrome
• 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)
• Possibility to cross the target lesion with OCT catheter

You may not qualify if:

• On-going cardiogenic shock
• Acute coronary syndrome related to target lesion
• Severe renal failure (Creatinine clearance: 30 ml/min/m2)
• Impossibility to cross target lesion with OCT catheter \& balloons,
• Indication for Rotablator device as first line therapy
• Pregnancy
• Age \< 18 y
• Denial to provide consent

Sponsors & Collaborators

• Institut Mutualiste Montsouris: lead
• Abbott: collaborator

Study Sites (14)

Ch de Bastia

Bastia, 20600, France

RECRUITING

CHU de Besançon

Besançon, 25000, France

RECRUITING

CHU de Bordeaux

Bordeaux, 33000, France

RECRUITING

Clinique Saint Augustin

Bordeaux, 33200, France

RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

Hôpital Louis Pasteur

Le Coudray, 28630, France

RECRUITING

L'Hôpital Privé du Confluent

Nantes, 44000, France

RECRUITING

CHU Nîmes

Nîmes, 30029, France

RECRUITING

Polyclinique les Fleurs

Ollioules, 83190, France

RECRUITING

CHU de Poitiers

Poitiers, 86000, France

RECRUITING

Clinique Saint-Hilaire

Rouen, 76000, France

RECRUITING

Institut Arnaud Tzanck,

Saint-Laurent-du-Var, 06700, France

RECRUITING

Clinique Pasteur

Toulouse, 31300, France

RECRUITING

Institut Mutualiste montsouris

Paris, Île-de-France Region, 75014, France

RECRUITING

Related Publications (1)

• Amabile N, Range G, Landolff Q, Bressollette E, Meneveau N, Lattuca B, Levesque S, Boueri Z, Adjedj J, Casassus F, Belfekih A, Veugeois A, Souteyrand G, Honton B. OCT vs Angiography for Guidance of Percutaneous Coronary Intervention of Calcified Lesions: The CALIPSO Randomized Clinical Trial. JAMA Cardiol. 2025 Jul 1;10(7):666-675. doi: 10.1001/jamacardio.2025.0741.

  PMID: 40305015 DERIVED

MeSH Terms

Conditions

Ornithine Carbamoyltransferase Deficiency Disease

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Urea Cycle Disorders, Inborn; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Nicolas Amabile, MD PhD

  Institut Mutualiste Montsouris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Amabile, MD PhD

CONTACT

0156616983; nicolas.amabile@imm.fr

Silvia Burbassi, PhD

CONTACT

0156616983; silvia.burbassi@imm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 29, 2022
• Study Start: December 15, 2021
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: November 15, 2022

Record last verified: 2022-04

Locations

FR (14)