## Protocol Section
### Identification Module
**NCT ID:** NCT06420505

**Acronym:** CELEBRITY

**Brief Title:** MULTICENTER OBSERVATORY EVALUATING THE POLYMER-FREE SIROLIMUS ELUTING CORONARY STENT SYSTEM VIVO ISAR 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)

#### Organization Study ID Info
**ID:** TRANSLUMINA
#### Organization
**Class:** INDUSTRY
**Full Name:** Translumina GmbH
### Status Module
#### Completion Date
**Date:** 2027-01-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-11-29

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-11-29

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** EVAMED

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Translumina GmbH

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Artery Coronary Stenosis

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 3000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** The Vivo ISAR is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease.

**Name:** Percutaneous Coronary Intervention

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** • 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

**Measure:** rate of target lesion failure

**Time Frame:** 12 months post-procedure

#### Secondary Outcomes

**Description:** • 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

**Measure:** Device success rate

**Time Frame:** 12 months post-procedure

**Description:** * 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

**Measure:** Procedural success rate

**Time Frame:** 7 days post-procedure

**Description:** Target Lesion Revascularization at 12 months

**Measure:** Assess reperfusion

**Time Frame:** 12 months post-procedure

**Description:** antiplatelet consumption during 1 year after the procedure

**Measure:** • Evaluate the antiplatelet treatment

**Time Frame:** 12 months post-procedure

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** beatrice.godefroy@translumina.fr

**Name:** Béatrice GODEFROY

**Phone:** 0623822906

**Phone Ext:** +33

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Aix-en-Provence

**Contacts:**

***Contact 1:***

- **Email:** luc.maillard@laposte.net

- **Name:** Luc Maillard, Dr

- **Role:** CONTACT

**Country:** France

**Facility:** Clinique Axium

**Status:** RECRUITING

**Zip:** 13100

**Location 2:**

**City:** Caen

**Contacts:**

***Contact 1:***

- **Email:** beygui-f@chu-caen.fr

- **Name:** Farzin Begui, Pr

- **Role:** CONTACT

**Country:** France

**Facility:** CHU CAEN

**Status:** NOT_YET_RECRUITING

**Zip:** 14000

**Location 3:**

**City:** Colmar

**Contacts:**

***Contact 1:***

- **Email:** amine.matari@diaconat-mulhouse.fr

- **Name:** Amine Matari, Dr

- **Role:** CONTACT

**Country:** France

**Facility:** Hôpital A. Schweitzer - GHCA

**Status:** RECRUITING

**Zip:** 68003

**Location 4:**

**City:** Essey-lès-Nancy

**Contacts:**

***Contact 1:***

- **Email:** ju.lemoine54@gmail.com

- **Name:** Julien Lemoine, Dr

- **Role:** CONTACT

**Country:** France

**Facility:** Clinique Louis Pasteur

**Status:** RECRUITING

**Zip:** 54271

**Location 5:**

**City:** Haguenau

**Contacts:**

***Contact 1:***

- **Email:** fabien@ch-haguenau.fr

- **Name:** Fabien DE POLI, Dr

- **Role:** CONTACT

**Country:** France

**Facility:** CH Haguenau

**Status:** RECRUITING

**Zip:** 67500

**Location 6:**

**City:** Marseille

**Contacts:**

***Contact 1:***

- **Email:** thomas.cuisset@mail.ap-hm.fr

- **Name:** Thomas Cuisset, Pr

- **Role:** CONTACT

**Country:** France

**Facility:** CHU La Timone

**Status:** RECRUITING

**Zip:** 13005

**Location 7:**

**City:** Marseille

**Contacts:**

***Contact 1:***

- **Email:** laurent.bonello@ap-hm.fr

- **Name:** Laurent Bonello, Pr

- **Role:** CONTACT

**Country:** France

**Facility:** Hopital Nord

**Status:** NOT_YET_RECRUITING

**Zip:** 13015

**Location 8:**

**City:** Massy

**Contacts:**

***Contact 1:***

- **Email:** p.garot@icps.com.fr

- **Name:** Philippe Garot, Dr

- **Role:** CONTACT

**Country:** France

**Facility:** HP Jacques Cartier

**Status:** RECRUITING

**Zip:** 91300

**Location 9:**

**City:** Montauban

**Contacts:**

***Contact 1:***

- **Email:** romain-andre@hotmail.fr

- **Name:** Romain André, Dr

- **Role:** CONTACT

**Country:** France

**Facility:** Clinique Pont de Chaume

**Status:** NOT_YET_RECRUITING

**Zip:** 82000

**Location 10:**

**City:** Nantes

**Contacts:**

***Contact 1:***

- **Email:** ashok.tirouvanziam@groupeconfluent.fr

- **Name:** Ashok Tirouvanziam, Dr

- **Role:** CONTACT

**Country:** France

**Facility:** Hôpital Privé du Confluent

**Status:** RECRUITING

**Zip:** 44277

**Location 11:**

**City:** Ollioules

**Contacts:**

***Contact 1:***

- **Name:** La Scala, Dr

- **Role:** CONTACT

**Country:** France

**Facility:** Polyclinique Les Fleurs

**Status:** RECRUITING

**Zip:** 83190

**Location 12:**

**City:** Paris

**Contacts:**

***Contact 1:***

- **Email:** gilles.montalescot@aphp.fr

- **Name:** Gille Montalescot, Dr

- **Role:** CONTACT

**Country:** France

**Facility:** APHP

**Status:** NOT_YET_RECRUITING

**Zip:** 75013

**Location 13:**

**City:** Quincy-sous-Sénart

**Contacts:**

***Contact 1:***

- **Email:** t.unterseeh@icps.com.fr

- **Name:** Thierry Unterseeh, Dr

- **Role:** CONTACT

**Country:** France

**Facility:** HP Claude Galien

**Status:** NOT_YET_RECRUITING

**Zip:** 91480

**Location 14:**

**City:** Reims

**Contacts:**

***Contact 1:***

- **Email:** lfaroux@chu-reims.fr

- **Name:** Laurent Faroux, Dr

- **Role:** CONTACT

**Country:** France

**Facility:** CHU Reims

**Status:** RECRUITING

**Zip:** 51000

**Location 15:**

**City:** Rouen

**Contacts:**

***Contact 1:***

- **Email:** mgodin@clinique-sainthilaire.fr

- **Name:** Matthieu Godin, Dr

- **Role:** CONTACT

**Country:** France

**Facility:** Clinique Saint Hilaire

**Status:** RECRUITING

**Zip:** 76000

**Location 16:**

**City:** Strasbourg

**Contacts:**

***Contact 1:***

- **Email:** Olivier.Morel@chru-strasbourg.fr

- **Name:** Olivier Morel, Pr

- **Role:** CONTACT

**Country:** France

**Facility:** CHRU Strasbourg

**Status:** NOT_YET_RECRUITING

**Zip:** 67091

**Location 17:**

**City:** Tarbes

**Contacts:**

***Contact 1:***

- **Email:** mabdennadher@ch-tarbes-vic.fr

- **Name:** Majdi Abdennadher, Dr

- **Role:** CONTACT

**Country:** France

**Facility:** CH de Bigorre

**Status:** RECRUITING

**Zip:** 65013

**Location 18:**

**City:** Toulouse

**Contacts:**

***Contact 1:***

- **Email:** dtchetche@clinique-pasteur.com

- **Name:** Didier Tchétché, Dr

- **Role:** CONTACT

**Country:** France

**Facility:** Clinique Pasteur

**Status:** NOT_YET_RECRUITING

**Zip:** 31076

**Location 19:**

**City:** Toulouse

**Contacts:**

***Contact 1:***

- **Email:** lhermusier.t@chu-toulouse.fr

- **Name:** Thibault Lhermusier, Pr

- **Role:** CONTACT

**Country:** France

**Facility:** Chu Toulouse

**Status:** RECRUITING

**Zip:** 31400

#### Overall Officials

**Official 1:**

**Affiliation:** CHU Toulouse

**Name:** Thibault Lhermusier, Pr

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003327

- Term: Coronary Disease

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M6475

- Name: Constriction, Pathologic

- Relevance: LOW

- As Found: Unknown

- ID: M22913

- Name: Coronary Stenosis

- Relevance: HIGH

- As Found: Coronary Stenosis

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: LOW

- As Found: Unknown

- ID: M6549

- Name: Coronary Disease

- Relevance: LOW

- As Found: Unknown

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000023921

- Term: Coronary Stenosis

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21960

- Name: Sirolimus

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
