Clinical trial NCT04698902: Influence of Calcium Pattern on Plaque Modification Achieved With Intracoronary Lithotripsy
Official title: Influence of Calcium Pattern on Plaque Modification Achieved With Intracoronary Lithotripsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Intracoronary Lithotripsy
Optical Coherence Tomography
Percutaneous Coronary Intervention
Calcification
Stent
Lead sponsor: Fundacion Investigacion Interhospitalaria Cardiovascular
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of lesions with Calcium Fractures
timeFrame: At the time of percutaneous coronary intervention
Secondary outcomes:
measure: Number of calcium fractures
timeFrame: At the time of percutaneous coronary intervention
measure: Number of quadrants with calcium fractures
timeFrame: At the time of percutaneous coronary intervention
measure: Calcium modification in eccentric versus concentric calcium
timeFrame: At the time of percutaneous coronary intervention
measure: Stent expansion
timeFrame: At the time of percutaneous coronary intervention
measure: Stent symmetry
timeFrame: At the time of percutaneous coronary intervention
measure: Stent symmetry
timeFrame: At the time of percutaneous coronary intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
Study officials:
References: