Influence of Calcium Pattern on Plaque Modification Achieved With Intracoronary Lithotripsy

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).

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Optical Coherence Tomography; Calcification; Stent; Intracoronary Lithotripsy
• Intervention / Treatment: Device: Intracoronary lithotripsy

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 Type: Observational
• Enrollment (Actual): 96

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with calcified coronary artery disease planned for percutaneous coronary intervention and stenting with the use of intravascular lithotripsy for calcium modification prior to stenting.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Circumferential calcification; Patients with circumferential pattern of coronary artery calcification by OCT (Optical coherence tomography) assessment (arc of calcium >180 degrees)	Device: Intracoronary lithotripsy; Intracoronary lithotripsy involves the use of sonic pressure waves generated from emitters enclosed within a balloon delivery system. The generated sonic waves act to fracture calcium within the coronary artery wall.
Eccentric calcification; Patients with an eccentric pattern of coronary artery calcification by OCT (Optical coherence tomography) assessment (arc of calcium <180 degrees)	Device: Intracoronary lithotripsy; Intracoronary lithotripsy involves the use of sonic pressure waves generated from emitters enclosed within a balloon delivery system. The generated sonic waves act to fracture calcium within the coronary artery wall.
Nodular calcification; Patients with calcium nodules identified by OCT (Optical coherence tomography) assessment	Device: Intracoronary lithotripsy; Intracoronary lithotripsy involves the use of sonic pressure waves generated from emitters enclosed within a balloon delivery system. The generated sonic waves act to fracture calcium within the coronary artery wall.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fundacion Investigacion Interhospitalaria Cardiovascular

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: January 5, 2021
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 20/599-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No