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NCT Number: NCT05113407

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

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.

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Key information

Conditions

Lithotripsy Angioplasty Coronary Balloon

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Pasteur

Toulouse, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

  1. To evaluate the device success

    Time frame: 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.

  2. To evaluate the procedural success in de novo lesions

    Time frame: 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").

  3. To evaluate the procedural success in stent malexpansion

    Time frame: 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

  4. To evaluate the rate of MACE during the year of follow-up

    Time frame: 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.

  5. To evaluate the rate of stent thrombosis during the year of follow-up

    Time frame: 1 year after procedure

    Rate of Stent thrombosis

  6. To evaluate the rate of target lesion failure during the year of follow-up

    Time frame: 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)

  7. To evaluate the rate of per-procedural coronary complications

    Time frame: 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

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Registry information

Acronym: France LILI

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Nov 9, 2021
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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