Registry for treating severe calcified coronary lesions with lithotripsy
The GISE-ShockCalcium Registry - An Investigator Driven Italian All Comers Registry of Calcified Lesions Treated With Intravascular Lithotripsy
This study is testing a new treatment called lithotripsy to see if it can safely help people with severe calcified blockages in their heart arteries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione GISE Onlus Academic / other |
| Locations | 1 site (Florence) |
| Trial ID | NCT05455515 on ClinicalTrials.gov |
What this trial studies
The GISE-SHOCKCALCIUM Registry is a prospective, observational registry aimed at evaluating the efficacy and safety of intravascular lithotripsy (IVL) for treating severe calcified coronary lesions. Conducted across approximately 50 interventional cardiology centers in Italy, the study plans to enroll 2000 patients over 24 months. The primary endpoint is target lesion failure at one year, with secondary endpoints focusing on safety and effectiveness measures. Data will be collected through a structured approach involving screening logs and clinical follow-ups.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with calcified coronary artery disease requiring percutaneous revascularization.
Not a fit: Patients who refuse to participate or do not meet the specific inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could improve treatment outcomes for patients with severe calcified coronary lesions.
How similar studies have performed: Other studies have shown promise with similar approaches, but this registry focuses specifically on the use of IVL for calcified lesions, making it a novel initiative.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Florence
- University Hospital Careggi Florence — Florence, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.