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

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.

Eligibility

Inclusion Criteria:

* 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,

  a) angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion, OR by b) IVUS or OCT, with presence of ≥270 degrees of calcium on at least 1 cross section
* Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel, prasugrel, or ticagrelor for 1 year and single antiplatelet therapy for life)
* Ability to give written informed consent.
* Patient is able and willing to comply with all follow-up assessments

Exclusion Criteria:

* 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)
* All the usual relative contraindications to coronary angioplasty according to the clinical practice:
* Patient has active systemic infection
* Patient has a known untreated coagulation disorder
* Patient has allergy to imaging contrast media for which he/she cannot be pre-medicated
* Patient is pregnant or nursing
* Patients whose life expectancy is \< 1 year
* Patients due to move abroad within 1 year

Conditions2

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