Actively Recruiting
Observatory on the Use of the Shockwave Medical C2 Coronary Lithotripsy System in the General Population in France.
Led by French Cardiology Society · Updated on 2025-02-10
500
Participants Needed
1
Research Sites
315 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Observatory on the Use of the Shockwave Medical C2 Coronary Lithotripsy System in the General Population in France.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over 18 years old
- Patient affiliated to the National Health Insurance System
- Patient undergoing coronary angioplasty using the Shockwave Medical C2 Coronary Lithotripsy System
- For stent malexpansion cases, defined by angiography showing malexpansion >30% or imaging with minimal stent area <4.5 mm2 or ratio of minimal stent area to reference segment <0.8
- Patient willing to participate in the registry
You will not qualify if you...
- Patient under 18 years of age
- Pregnant or breastfeeding patient
- Patient refusing to participate or unable to give informed consent due to guardianship or legal reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Clinique Pasteur
Toulouse, France
Actively Recruiting
Research Team
B
Benjamin HONTON
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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