Condition: Coronary Disease · Sponsor: Fondazione GISE Onlus
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.
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| University Hospital Careggi Florence | Florence, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05455515