Influence of Calcium Pattern on Plaque Modification Achieved With Intracoronary Lithotripsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-05-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No