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

March 30, 2023 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

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

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 Locations

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
Coronary angioplasty performed using the Shockwave Medical C2 Coronary Lithotripsy System

What is the study measuring?

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.
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

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

French Cardiology Society

Investigators

  • 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)

November 16, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

October 14, 2021

First Submitted That Met QC Criteria

October 28, 2021

First Posted (Actual)

November 9, 2021

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID 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.

Clinical Trials on Angioplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe