Evaluation of the Vivo Isar Stent System in routine clinical practice

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Clinique Axium
  Aix-en-Provence, France 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
• HP Jacques Cartier
  Massy, France Recruiting

Study contacts

• Principal investigator: Thibault Lhermusier, Pr — University Hospital, Toulouse
• Study coordinator: Béatrice GODEFROY
• Email: beatrice.godefroy@translumina.fr
• Phone: 0623822906

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.