Evaluation of the Vivo Isar Stent System in Routine Clinical Practice

Artery Coronary Stenosis Clinical Trial

— CELEBRITY  

Official title:

Multicenter Observatory Evaluating the Polymer-Free Sirolimus Eluting Coronary Stent System VIVO ISAR in Routine Clinical Practice (CELEBRITY Observatory)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06420505
• Other study ID #: TRANSLUMINA
• Status: Recruiting
• Start date: November 29, 2023
• Est. completion date: January 1, 2027

Study information

• Verified date: May 2024
• Source: Translumina GmbH
• Contact: Béatrice GODEFROY
• Phone: 0623822906
• Email: beatrice.godefroy[@]translumina.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: January 1, 2027
• Est. primary completion date: November 29, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Artery Coronary Stenosis
• Coronary Stenosis

Intervention

Device:
• Percutaneous Coronary Intervention
The Vivo ISAR is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease.

Locations

Country	Name	City	State
France	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	Polyclinique Les Fleurs	Ollioules
France	APHP	Paris
France	HP Claude Galien	Quincy-sous-Sénart
France	CHU Reims	Reims
France	Clinique Saint Hilaire	Rouen
France	CHRU Strasbourg	Strasbourg
France	CH de Bigorre	Tarbes
France	Chu Toulouse	Toulouse
France	Clinique Pasteur	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Translumina GmbH	EVAMED

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of target lesion failure	• 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	12 months post-procedure
Secondary	Device success rate	• Device success rate defined as successful placement and deployment of the device at the target lesion site with successful removal of the delivery system leaving a final residual stenosis <30% of the segment of the culprit lesion covered by the stent at 1 year	12 months post-procedure
Secondary	Procedural success rate	Procedural success rate defined as device success without major ischemia-related adverse cardiac events during hospitalization and up to a maximum of 7 days post-procedure : Cardiac death; Any MI; Target-vessel MI	7 days post-procedure
Secondary	Assess reperfusion	Target Lesion Revascularization at 12 months	12 months post-procedure
Secondary	• Evaluate the antiplatelet treatment	antiplatelet consumption during 1 year after the procedure	12 months post-procedure