The GISE (Società Italiana di Cardiologia Interventistica) - ShockCalcium Registry
ConditionCoronary Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione GISE Onlus
About this trial
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.
Eligibility criteria
Qualifiers
Patients is ≥ 18 years of age.
Patients with calcified coronary artery disease requiring percutaneous revascularization with stent implantation who require an IVL with the Shockwave catheter.
Presence of single or multiple calcifications at the lesion site defined by,
Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel, prasugrel, or ticagrelor for 1 year and single antiplatelet therapy for life)
Disqualifiers
Refusal to participate in this study.
Calcific lesion within a > 4 mm reference segment of the vessel
Lesions in LIMA(left internal mammary artery)/RIMA (rightinternal mammary artery) or at the distal anastomosis of an SVG (saphenous vein grafts)
Patient has active systemic infection
Trial design
Treatments tested in this trial
- IVL procedures
Treatment groups
No treatment groups listed
Sponsors and collaborators
Fondazione GISE Onlus
Lead sponsor
Shockwave Medical, Inc.
Collaborator
INNOVA HTS SRL
Collaborator
University of Padova
Collaborator
Source ClinicalTrials.gov