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

Recruiting

• Conditions: Angioplasty; Coronary Balloon; Lithotripsy

• Registration Number: NCT05113407
• Lead Sponsor: French Cardiology Society

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-14
• Study First Submitted QC: 2021-10-28
• Study First Posted: 2021-11-09
• Study Start: 2021-11-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and performance of the Shockwave Medical® C2 Coronary Lithotripsy System (IVL), Inc. in coronary angioplasty in "all patients" in France.	1 year after procedure	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)

Secondary Outcome Measures

Name	Time	Method
To evaluate the procedural success in de novo lesions	During initial hospitalization, within 2-4 days after procedure	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").
To evaluate the procedural success in stent malexpansion	During initial hospitalization, within 2-4 days after procedure	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
To evaluate the rate of MACE during the year of follow-up	1 year after procedure	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.
To evaluate the rate of stent thrombosis during the year of follow-up	1 year after procedure	Rate of Stent thrombosis
To evaluate the rate of per-procedural coronary complications	During initial hospitalization, within 2-4 days after procedure	Rate of Coronary complication as Dissection (A-F), Slow Flow, No reFlow and abrupt vessel occlusion, Perforation
To evaluate the device success	During initial hospitalization, within 2-4 days after procedure	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.
To evaluate the rate of target lesion failure during the year of follow-up	1 year after procedure	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)

Trial Locations

Locations (1)

Clinique Pasteur; 🇫🇷 Toulouse, France