Status:
COMPLETED
Influence of Calcium Pattern on Plaque Modification Achieved With Intracoronary Lithotripsy
Lead Sponsor:
Fundacion Investigacion Interhospitalaria Cardiovascular
Conditions:
Coronary Artery Disease
Intracoronary Lithotripsy
Eligibility:
All Genders
18+ years
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 tre...
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 cor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04698902
Start Date
November 1 2020
End Date
May 1 2022
Last Update
March 6 2024
Active Locations (1)
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1
Hospital Clínico San Carlos
Madrid, Spain, 28040