Clinical trial NCT06420505: Evaluation of the Vivo Isar Stent System in Routine Clinical Practice
Official title: Multicenter Observatory Evaluating the Polymer-Free Sirolimus Eluting Coronary Stent System VIVO ISAR in Routine Clinical Practice (CELEBRITY Observatory)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Artery Coronary Stenosis
Lead sponsor: Translumina GmbH
Sponsor class: INDUSTRY
Collaborators: name: EVAMED
First posted: 2024-05-20
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all-comers population who qualify for percutaneous coronary intervention (consisting of patients with symptomatic coronary artery disease including chronic coronary syndromes (CCS) and ACS) of any gender, ≥ 18 years old

Brief 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 criteria: 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 outcomes:
measure: rate of target lesion failure
timeFrame: 12 months post-procedure
Secondary outcomes:
measure: Device success rate
timeFrame: 12 months post-procedure
measure: Procedural success rate
timeFrame: 7 days post-procedure
measure: Assess reperfusion
timeFrame: 12 months post-procedure
measure: • Evaluate the antiplatelet treatment
timeFrame: 12 months post-procedure
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Clinique Axium
city: Caen
country: France
facility: CHU CAEN
city: Colmar
country: France
facility: Hôpital A. Schweitzer - GHCA
city: Essey-lès-Nancy
country: France
facility: Clinique Louis Pasteur
city: Haguenau
country: France
facility: CH Haguenau
city: Marseille
country: France
facility: CHU La Timone
city: Marseille
country: France
facility: Hopital Nord
city: Massy
country: France
facility: HP Jacques Cartier
city: Montauban
country: France
facility: Clinique Pont de Chaume
city: Nantes
country: France
facility: Hôpital Privé du Confluent
city: Ollioules
country: France
facility: Polyclinique Les Fleurs
city: Paris
country: France
facility: APHP
city: Quincy-sous-Sénart
country: France
facility: HP Claude Galien
city: Reims
country: France
facility: CHU Reims
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Strasbourg
country: France
facility: CHRU Strasbourg
city: Tarbes
country: France
facility: CH de Bigorre
city: Toulouse
country: France
facility: Clinique Pasteur
city: Toulouse
country: France
facility: Chu Toulouse
Study officials:
affiliation: CHU Toulouse
name: Thibault Lhermusier, Pr
role: PRINCIPAL_INVESTIGATOR
References: