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RECRUITING
NCT05455515

The GISE (Società Italiana di Cardiologia Interventistica) - ShockCalcium Registry

Sponsor: Fondazione GISE Onlus

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

IVL procedures

Intravascular Lithotripsy (IVL)

Locations (1)

University Hospital Careggi Florence

Florence, Italy