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

NCT05455515 | Recruiting DMC

• 1 other identifier: GISE_Shockcalcium
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Primary composite safety endpoint: Target lesion failure (TLF): cardiovascular death

  Cardiovascular death defined as death resulting from cardiovascular causes: 1. death caused by acute MI 2. death caused by sudden cardiac arrest, including unwitnessed death 3. death resulting from heart failure 4. death caused by stroke 5. death caused by cardiovascular procedures 6. death resulting from cardiovascular hemorrhage 7. death resulting from other cardiovascular cause

  at 1 year

• Primary composite safety endpoint: Target lesion failure (TLF): Target-vessel Myocardial infarction (TV-MI)

  based on CK-MB level \>3x ULN with or without new pathologic Q-wave through discharge (peri-procedural MI) and using the 4th Universal Definition of MI beyond discharge

  at 1 year

• Primary composite safety endpoint: Target lesion failure (TLF): Target lesion revascularization (TLR)

  defined as a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion, clinically or ischemia driven

  at 1 year

Secondary Outcomes (6)

• Secondary safety endpoints: in Hospital Target lesion failure (TLF)

  at 1 year

• Secondary safety endpoints: Target lesion failure

  at 30 days

• Secondary safety endpoints: Definite or probable stent thrombosis

  at 1 year

• Secondary safety endpoints: Procedural angiographic safety endpoints

  at 1 year

• Secondary effectiveness endpoints: Device crossing and IVL delivery success

  at 1 year

Interventions

IVL procedures PROCEDURE

Intravascular Lithotripsy (IVL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with coronary calcified lesions

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione GISE Onlus: lead
• Shockwave Medical, Inc.: collaborator
• INNOVA HTS SRL: collaborator
• University of Padova: collaborator

Study Sites (1)

University Hospital Careggi Florence

Florence, Italy

RECRUITING

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: July 13, 2022
• Study Start: September 17, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 4, 2024

Record last verified: 2024-03

Locations

IT (1)