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

NCT05455515 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2024-03-04

No results posted yet for this study

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.

Conditions

  • Coronary Disease

Interventions

PROCEDURE

IVL procedures

Intravascular Lithotripsy (IVL)

Sponsors & Collaborators

  • Shockwave Medical, Inc.

    collaborator INDUSTRY

  • INNOVA HTS SRL

    collaborator UNKNOWN

  • University of Padova

    collaborator OTHER

  • Fondazione GISE Onlus

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-17
Primary Completion
2026-08-01
Completion
2026-08-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05455515 on ClinicalTrials.gov