Ireland
--:--IST
Recruiting Observational

Evaluation of the Vivo Isar Stent System in Routine Clinical Practice

NCT06420505 · tracked via the Priya Life Science France tracker
Sponsor
Translumina GmbH
Phase
Observational
Started
2023-11-29
Last updated
2024-06-06

Condition(s) studied

Artery Coronary Stenosis

Investigational drug(s) / intervention(s)

Percutaneous Coronary Intervention

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

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)

FacilityCityRegionStatus
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
Official registry record

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