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

June 11, 2026 updated by: French Cardiology Society
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Toulouse, France
        • Clinique Pasteur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients will be included in cardiology departments participating in the study. The study may be offered to any patient undergoing coronary artery angioplasty using the Shockwave Medical C2 coronary lithotripsy system.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Coronary angioplasty performed using the Shockwave Medical C2 Coronary Lithotripsy System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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)
1 year after procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
During initial hospitalization, within 2-4 days after procedure
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").
During initial hospitalization, within 2-4 days after procedure
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
During initial hospitalization, within 2-4 days after procedure
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.
1 year after procedure
To evaluate the rate of stent thrombosis during the year of follow-up
Time Frame: 1 year after procedure
Rate of Stent thrombosis
1 year after procedure
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)
1 year after procedure
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
During initial hospitalization, within 2-4 days after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
French Cardiology Society

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Benjamin HONTON, Clinique Pasteur - France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-A01876-35

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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