Observing the use of a new device for treating coronary calcified lesions in France
Observatory on the Use of the Shockwave Medical C2 Coronary Lithotripsy System in the General Population in France.
This study looks at how well a new device works for treating hard, calcified blockages in heart arteries during angioplasty to help patients get better results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | French Cardiology Society Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT05113407 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the use of the Shockwave Medical C2 Coronary Lithotripsy System for treating calcified coronary lesions in patients undergoing angioplasty. The study aims to document the effectiveness and safety of this innovative device, which utilizes lithotripsy to create microfractures in calcified plaques, potentially improving stent delivery. By analyzing real-world data from patients treated with this system, the study seeks to address the challenges posed by calcified lesions in coronary interventions. The findings may provide valuable insights into the device's impact on clinical outcomes and procedural complications.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are undergoing coronary angioplasty with the Shockwave Medical C2 Coronary Lithotripsy System.
Not a fit: Patients under 18 years of age, pregnant or breastfeeding, or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the treatment of coronary calcified lesions, leading to better patient outcomes during angioplasty procedures.
How similar studies have performed: While this approach is relatively novel, previous studies on lithotripsy for coronary lesions have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Toulouse
- Clinique Pasteur — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Benjamin HONTON — Clinique Pasteur - France
- Study coordinator: Benjamin HONTON
- Email: bhonton@clinique-pasteur.com
- Phone: 0562211699
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.