Observatory on the Use of the Shockwave Medical C2 Coronary Lithotripsy System in the General Population in France.

Study Overview
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Brief Summary
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Coronary calcified lesions will have an increasing impact in the daily practice of coronary angioplasty, considering the epidemiological explosion of factors favoring coronary calcifications, first of all diabetes. Moreover, calcified lesions are underestimated in angiography and associated with an increase in angiographic complications, as well as with a worse clinical prognosis. The usual techniques for the preparation of calcified plaque, in particular rotary atherectomy, have a low penetration rate in France (3% of procedures) and are associated with an increase in per-procedural complications without clinical evidence of effectiveness4. A new device has been developed by Schockwave Medical Inc. for the treatment of calcified lesions to facilitate stent delivery: the C2 Shockwave Medical® Coronary Lithotripsy System (IVL), Inc. This system uses the principle of lithotripsy to induce microfractures in the calcified plaque prior to low-pressure balloon dilatation. The objective of the study is to evaluate the safety and performance of the C2 Shockwave Medical® (IVL), Inc. coronary lithotripsy system in coronary angioplasty in the general population in France.

Official Title
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Observatory on the Use of the Shockwave Medical C2 Coronary Lithotripsy System in the General Population in France.

Conditions
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Lithotripsy, Angioplasty, Coronary Balloon

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient over 18 years old Patient affiliated to the National Health Insurance System Patient for whom a coronary angioplasty procedure is performed using the Shockwave Medical C2 Coronary Lithotripsy System For indications of stent malexpansions, stent malexpansion must be defined by: a) angiography: stent malexpansion >30% (QCA and/or stent magnification) b) endocoronary OCT/IVUS imaging with MSA (Minimal Stent Area) <4.5 mm2 or a ratio of MSA/MLA on reference segment<0.8 Patient willing to participate in the registry Exclusion Criteria: Patient under 18 years of age Pregnant or breastfeeding patient Patient refusing to participate in the study or unable to give informed consent (patient under guardianship, curatorship or legal guardianship)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coronary angioplasty performed using the Shockwave Medical C2 Coronary Lithotripsy System<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and performance of the Shockwave Medical® C2 Coronary Lithotripsy System (IVL), Inc. in coronary angioplasty in all patients in France. | Target Vessel Failure (TVF) composite endpoint at 1 year: Cardiac death Myocardial infarction according to ARC II definition of myocardial infarction (unless the infarction is clearly attributable to a non-target vessel) Target vessel revascularization (TVR) | 1 year after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the device success | Ability to deliver the Shockwave Medical Coronary C2 Lithotripsy System to the lesion site to be treated and achieve a residual lesion < 50% after application of acoustic therapy. | During initial hospitalization, within 2-4 days after procedure | 
| To evaluate the procedural success in de novo lesions | Procedural success is defined as stent placement with < 20% residual stenosis and no serious angiographic complications (i.e., acute dissection (types D through F), perforation, acute obstruction, persistent slow flow or no reflow). | During initial hospitalization, within 2-4 days after procedure | 
| To evaluate the procedural success in stent malexpansion | Post-IVL procedural success is defined by a) malexpansion < 20% (QCA and/or Stent magnification) and/or b) endocoronary OCT/IVUS imaging with a MSA (Minimal Stent Area) >4.5 mm2 | During initial hospitalization, within 2-4 days after procedure | 
| To evaluate the rate of MACE during the year of follow-up | Evaluate the rate of events considered as Major adverse cardiac events (MACE classification) : all-cause death, myocardial infarction (including non-target vessel MI), any coronary revascularization. | 1 year after procedure | 
| To evaluate the rate of stent thrombosis during the year of follow-up | Rate of Stent thrombosis | 1 year after procedure | 
| To evaluate the rate of target lesion failure during the year of follow-up | Evaluate the rate of Target lesion failure (Device-oriented endpoint) = addition of rates of events like cardiac death, myocardial infarction (unless clearly attributable to a vessel other than the target vessel) and target lesion revascularization (TLR) | 1 year after procedure | 
| To evaluate the rate of per-procedural coronary complications | Rate of Coronary complication as Dissection (A-F), Slow Flow, No reFlow and abrupt vessel occlusion, Perforation | During initial hospitalization, within 2-4 days after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lithotripsy, Coronary calcified lesion, coronary angioplasty