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The GISE (Società Italiana di Cardiologia Interventistica) - ShockCalcium Registry
Sponsor: Fondazione GISE Onlus
Summary
The GISE-SHOCKCALCIUM Registry is an Investigator Driven Italian All Comers prospective, observational, multicenter Italian IVL registry of Calcified lesions Treated with Intravascular Lithotripsy. The main purpose is to evaluate the efficacy and safety of coronary lithotripsy for treatment of severe calcified lesion. A total of 2000 patients with coronary calcified lesions will be enrolled in 24 months. The registry will be conducted in approximately 50 interventional cardiology centers in Italy with at least 2 IVL procedures per 24 months. Primary endpoint: Target lesion failure (TLF) at 1 year. Secondary safety endpoints: in Hospital Target lesion failure (TLF); Target Lesion Failure at 30 days; definite or probable stent thrombosis; procedural angiographic safety endpoints. Secondary effectiveness endpoints: device crossing and IVL delivery success; angiographic success; QCA (quantitative coronary angiography) outcome; Imaging outcome.
Official title: The GISE-ShockCalcium Registry - An Investigator Driven Italian All Comers Registry of Calcified Lesions Treated With Intravascular Lithotripsy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
2000
Start Date
2022-09-17
Completion Date
2026-08-01
Last Updated
2024-03-04
Healthy Volunteers
No
Conditions
Interventions
IVL procedures
Intravascular Lithotripsy (IVL)
Locations (1)
University Hospital Careggi Florence
Florence, Italy