Influence of Calcium Pattern on Plaque Modification Achieved With Intracoronary Lithotripsy

NCT04698902 | Completed

• 1 other identifier: 20/599-E
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Artery Disease; Intracoronary Lithotripsy; Optical Coherence Tomography; Percutaneous Coronary Intervention; Calcification; Stent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of calcium fractures

  At the time of percutaneous coronary intervention

• Number of quadrants with calcium fractures

  At the time of percutaneous coronary intervention

• Calcium modification in eccentric versus concentric calcium

  At the time of percutaneous coronary intervention

• Stent expansion

  At the time of percutaneous coronary intervention

• Stent symmetry

  At the time of percutaneous coronary intervention

Study Arms (3)

Circumferential calcification

Patients with circumferential pattern of coronary artery calcification by OCT (Optical coherence tomography) assessment (arc of calcium \>180 degrees)

Device: Intracoronary lithotripsy

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

Nodular calcification

Patients with calcium nodules identified by OCT (Optical coherence tomography) assessment

Device: Intracoronary lithotripsy

Interventions

Intracoronary lithotripsy DEVICE

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.

Circumferential calcification; Eccentric calcification; Nodular calcification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Investigacion Interhospitalaria Cardiovascular: lead

Study Sites (1)

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Coronary Artery Disease; Calcinosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 7, 2021
• Study Start: November 1, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

ES (1)