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

French Cardiology Society

Status: Enrolling

Conditions: Lithotripsy; Angioplasty; Coronary Balloon

Study type: Observational

Funder types: Other

Identifiers

NCT05113407

2021-A01876-35

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

500 participants in 1 patient group

Coronary angioplasty performed using the Shockwave Medical C2 Coronary Lithotripsy System