Evaluation of the Vivo Isar Stent System in routine clinical practice
Multicenter Observatory Evaluating the Polymer-Free Sirolimus Eluting Coronary Stent System VIVO ISAR in Routine Clinical Practice (CELEBRITY Observatory)
This study is testing how well the Vivo ISAR stent works for people with coronary artery disease over a year to see if it’s safe and effective in everyday use.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Translumina GmbH Industry-sponsored |
| Locations | 19 sites (Aix-en-Provence and 18 other locations) |
| Trial ID | NCT06420505 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical outcomes of the Polymer Free Sirolimus Eluting Coronary Stent System in patients with coronary artery disease (CAD) over a 12-month follow-up period. It will collect real-world data on the effectiveness and safety of the Vivo ISAR stent during routine clinical practice. All procedures and medications used will adhere to standard care protocols, ensuring patient safety and well-defined outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with acute or chronic coronary syndrome who require stenting with the Vivo ISAR stent.
Not a fit: Patients with concurrent medical conditions that significantly limit life expectancy or those who have recently undergone stenting with a different device may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of the Vivo ISAR stent, potentially improving treatment options for patients with coronary artery disease.
How similar studies have performed: While this study is observational, similar studies evaluating stent systems have shown promising results in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥18 years old * Ability to provide signed informed consent form. * Male or non-pregnant female patient (Pregnancy status to be confirmed verbally from the female patient of reproductive age) * Presentation with acute coronary syndrome or chronic coronary syndrome with stable angina or angina equivalent symptoms or with a positive noninvasive test for ischemia or evidence of a functionally significant coronary stenosis. * Patient having social security number. * Patient treated only with Vivo ISAR stent in case of single or multiple vessel stenting Exclusion Criteria: * Concurrent participation in another clinical trial. * Having benefited from an angioplasty of ≤ 1 month with a stent other than Vivo ISAR. * Planned elective surgery in next 6 months * Cardiogenic shock/ hemodynamically unstable patients * Concurrent medical condition with a life expectancy of less than 12 months * History of cerebrovascular accident in the last 6 months. * Vulnerable patient under guardianship or curatorship
Where this trial is running
Aix-en-Provence and 18 other locations
- Clinique Axium — Aix-en-Provence, France (Recruiting)
- Chu Caen — Caen, France (Not_yet_recruiting)
- Hôpital A. Schweitzer - GHCA — Colmar, France (Recruiting)
- Clinique Louis Pasteur — Essey-lès-Nancy, France (Recruiting)
- CH Haguenau — Haguenau, France (Recruiting)
- CHU La Timone — Marseille, France (Recruiting)
- Hopital Nord — Marseille, France (Not_yet_recruiting)
- HP Jacques Cartier — Massy, France (Recruiting)
- Clinique Pont de Chaume — Montauban, France (Not_yet_recruiting)
- Hôpital Privé du Confluent — Nantes, France (Recruiting)
- Polyclinique Les Fleurs — Ollioules, France (Recruiting)
- Aphp — Paris, France (Not_yet_recruiting)
- HP Claude Galien — Quincy-sous-Sénart, France (Not_yet_recruiting)
- CHU Reims — Reims, France (Recruiting)
- Clinique Saint Hilaire — Rouen, France (Recruiting)
- CHRU Strasbourg — Strasbourg, France (Not_yet_recruiting)
- CH de Bigorre — Tarbes, France (Recruiting)
- Clinique Pasteur — Toulouse, France (Not_yet_recruiting)
- Chu Toulouse — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Thibault Lhermusier, Pr — University Hospital, Toulouse
- Study coordinator: Béatrice GODEFROY
- Email: beatrice.godefroy@translumina.fr
- Phone: 0623822906
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.