Loading clinical trials...

Evaluation of the Vivo Isar Stent System in Routine Clinical Practice | Clinical Trials | Clareo Health

RECRUITING

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)

NCT06420505•Translumina GmbH

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (19)

Clinique Axium

Aix-en-Provence, France

CHU CAEN

Caen, France

Hôpital A. Schweitzer - GHCA

Colmar, France

Clinique Louis Pasteur

Essey-lès-Nancy, France

CH Haguenau

Haguenau, France

CHU La Timone

Marseille, France

Hopital Nord

Marseille, France

HP Jacques Cartier

Massy, France

Clinique Pont de Chaume

Montauban, France

Hôpital Privé du Confluent

Nantes, France

Key Dates

Start Date

November 29, 2023

Primary Completion Date

November 29, 2026

Completion Date

January 1, 2027

Last Updated

June 6, 2024

Enrollment

3,000

ESTIMATED participants

Conditions

Artery Coronary Stenosis

Interventions

Percutaneous Coronary Intervention

DEVICE

Contacts

Béatrice GODEFROY

CONTACT

0623822906 beatrice.godefroy@translumina.fr

Thrombin Generation Values and Percutaneous Coronary Intervention Results.

NCT03391622

Coagulation DisorderIschemic Heart Disease+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions