Influence of Calcium Pattern on Plaque Modification Achieved With Intracoronary Lithotripsy

Completed

• Conditions: Intracoronary Lithotripsy; Stent; Coronary Artery Disease; Percutaneous Coronary Intervention; Calcification; Optical Coherence Tomography
• Interventions: Device: Intracoronary lithotripsy

• Registration Number: NCT04698902
• Lead Sponsor: Fundacion Investigacion Interhospitalaria Cardiovascular

Brief Summary

Calcified coronary artery disease is a frequently encountered problem that can lead to poorer outcomes for patients undergoing PCI. Recently, intravascular lithotripsy has become available for the treatment of callcified coronary artery disease. The effect of intravascular lithotripsy on varying calcium patterns has not been adequately explored.

This is an investigator initiated, open label, non-blinded, observational study involving a number of centers in Spain examining the effect of intravasuclar lithotripsy in varying calcium patterns. 100 patients wll be enrolled. Optical coherence tomography will be used to assess the effect of intravascular lithotripsy on varying calcium patterns (concentric, eccentric and nodular).

Detailed Description

Calcified coronary artery disease continues to present a challenge for Interventional Cardiologists. Moderate calcification is found in over 25% of coronary artery lesions planned for percutaneous coronary intervention (PCI). Outcomes for patients undergoing PCI to calcified lesions have been shown to be consistently poorer than in non-calcified lesions. Recently, intravascular lithotripsy has become available for the treatment of calcified coronary artery disease. The effect of intravascular lithotripsy on varying calcium patterns has not been adequately explored.

This is an investigator initiated, open label, non-blinded, observational study involving a number of centers in Spain. Patients with an indication of PCI and with a significant calcium burden requiring modification will be invited to participate. PCI procedures will be performed via either radial or femoral access as deemed appropriate by the operator and in accordance with local protocols. Intravascular imaging using OCT will be performed prior to calcium modification to define the pattern of calcium, after calcium modification to assess the effectiveness of IVL therapy and after stent implantation to assess stent expansion.

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-07
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Patients >18 years of age
• Patients with an indication for PCI (ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of >50% de novo severely calcified coronary stenosis that requires IVL treatment.

Exclusion Criteria

• Patients unwilling or unable to sign informed consent for the procedure
• Patients with severe peripheral vascular disease limiting vascular access to the extent that it is unsafe to perform the procedure
• Patients with severe renal dysfunction (eGFR <15mls/min and not receiving dialysis)
• Treatment of vessels < 2.5mm diameter which are not amenable to IVL treatment or OCT assessment.
• Treatment of lesions located very distally in the coronary vessel where the OCT catheter may not reach.
• Inability to cross the lesion with the OCT catheter due to very severe stenosis or severe vessel tortuosity.
• Ostial left main stem or right coronary artery lesions which may be difficult to visualise by OCT
• Patients requiring concomitant use of rotational or orbital atherectomy of LASER.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eccentric calcification	Intracoronary lithotripsy	Patients with an eccentric pattern of coronary artery calcification by OCT (Optical coherence tomography) assessment (arc of calcium \<180 degrees)
Nodular calcification	Intracoronary lithotripsy	Patients with calcium nodules identified by OCT (Optical coherence tomography) assessment
Circumferential calcification	Intracoronary lithotripsy	Patients with circumferential pattern of coronary artery calcification by OCT (Optical coherence tomography) assessment (arc of calcium \>180 degrees)

Primary Outcome Measures

Name	Time	Method
Percentage of lesions with Calcium Fractures	At the time of percutaneous coronary intervention	Percentage of lesions showing calcium modification (fractures) after intravascular lithotripsy (IVL) in nodular eccentric and concentric calcium patterns

Secondary Outcome Measures

Name	Time	Method
Calcium modification in eccentric versus concentric calcium	At the time of percutaneous coronary intervention	Percentage of lesions with calcium arc \<180 versus \>180 degrees with fractures as assessed by OCT
Number of quadrants with calcium fractures	At the time of percutaneous coronary intervention	Number of quadrants with calcium fractures after IVL treatment as assessed by OCT
Number of calcium fractures	At the time of percutaneous coronary intervention	Number of calcium fractures visible on OCT after IVL treatment
Stent expansion	At the time of percutaneous coronary intervention	Percentage stent expansion in patients with and without calcium modification (fractures) after application of IVL
Stent symmetry	At the time of percutaneous coronary intervention	Stent symmetry index in patients with concentric versus eccentric calcification

Trial Locations

Locations (1)

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain