Evaluation of the Vivo Isar Stent System in Routine Clinical Practice
Condition(s) studied
Investigational drug(s) / intervention(s)
Percutaneous Coronary Intervention: The Vivo ISAR is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease.
Study summary
The rationale for this observatory is to evaluate clinical outcomes and collect data of the Polymer Free Sirolimus Eluting Coronary Stent System in Real World CAD Patients with follow-up at 12 months. All medications and procedures to be used/ performed in this observatory are commonly used/performed for clinical indications as part of standard of care and have well-defined safety profiles.
Eligibility
Primary outcome measure(s)
- rate of target lesion failure — 12 months post-procedure
• The rate of target lesion failure at 12 months follow-up defined as the composite endpoint of: * Cardiac death * Myocardial infarction related to the target vessel * Clinically documented target lesion revascularization
Trial sites (19)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06420505 on ClinicalTrials.gov ↗ ← All trials in France