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
This trial does not accept healthy volunteersQualifiers
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 population
patients with coronary calcified lesions
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
IVL procedures
Procedure/SurgeryIntravascular Lithotripsy (IVL)
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
at 1 year2
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
Time frame
at 1 year3
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
Time frame
at 1 yearSecondary outcomes
1
Secondary safety endpoints: in Hospital Target lesion failure (TLF)
defined as a composite of cardiac death, target vessel related non-fatal myocardial infarction or need for unplanned target lesion revascularization
Time frame
at 1 year2
Secondary safety endpoints: Target lesion failure
defined as a composite of cardiac death, target vessel related non-fatal myocardial infarction or need for unplanned target lesion revascularization
Time frame
at 30 days3
Secondary safety endpoints: Definite or probable stent thrombosis
Definite stent thrombosis (ST) OR Pathological confirmation of ST determined by the evidence of recent thrombus within the stent at autopsy and/or examination of tissue retrieved following thrombectomy (visual/histology). Probable ST: Regardless of the time after the index procedure, any myocardial infarction that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent/scaffold thrombosis and in the absence of any other obvious cause)25. Timing of ST: Acute 0\*-24h Subacute \>24h-30day Late 30 day-1 year \*0 is defined as the moment the patient is undraped and taken off the catheterization table25
Time frame
at 1 year4
Secondary safety endpoints: Procedural angiographic safety endpoints
1. severe dissection: dissection in the target vessel greater than type B from National Heart, Lung, and Blood Institute classification 2. coronary perforation defined as evidence of extravasation of dye or blood from the coronary artery during or following the interventional procedure. This is detected either by angiographic appearances consistent with dye outside of the vessel lumen or by echocardiographic evidence of a pericardial effusion. 3. abrupt closure defined as an abrupt cessation of coronary flow to TIMI grade 0 or 1 flow before or at ≤5 mm distal to the lesion in an artery in which PTCA was attempted where there had previously been TIMI grade 2 or 3 flow prior to the procedure. 4. slow flow or no-reflow: markedly delayed flow (TIMI grade 2 for slow flow, TIMI 0 or 1 for no reflow) in a target vessel with minimal (\<30%) residual stenosis at the stented/scaffolded segment and no evidence of flow-limiting dissection
Time frame
at 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fondazione GISE Onlus
Lead sponsor
Shockwave Medical, Inc.
Collaborator
INNOVA HTS SRL
Collaborator
University of Padova
Collaborator
Source ClinicalTrials.gov