Artery Coronary StenosisCELEBRITYNCT06420505
Evaluation of the Vivo Isar Stent System in Routine Clinical Practice
An observational study of Artery Coronary Stenosis, run by Translumina GmbH at 19 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Artery Coronary Stenosis
- What is being tested?
- Percutaneous Coronary Intervention
- Type of treatment
- Medical device
- How many people
- 3,000 participants
- Where
- 19 sitesFrance
- Study dates
- 29 Nov 2023to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- 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
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
France19 sites, 19 recruiting
- Recruiting
Clinique Axium
Aix-en-Provence, 13100
Luc Maillard, Dr, luc.maillard@laposte.net
- Not yet recruiting
CHU CAEN
Caen, 14000
Farzin Begui, Pr, beygui-f@chu-caen.fr
- Recruiting
Hôpital A. Schweitzer - GHCA
Colmar, 68003
Amine Matari, Dr, amine.matari@diaconat-mulhouse.fr
- Recruiting
Clinique Louis Pasteur
Essey-lès-Nancy, 54271
Julien Lemoine, Dr, ju.lemoine54@gmail.com
- Recruiting
CH Haguenau
Haguenau, 67500
Fabien DE POLI, Dr, fabien@ch-haguenau.fr
- Recruiting
CHU La Timone
Marseille, 13005
Thomas Cuisset, Pr, thomas.cuisset@mail.ap-hm.fr
- Not yet recruiting
Hopital Nord
Marseille, 13015
Laurent Bonello, Pr, laurent.bonello@ap-hm.fr
- Recruiting
HP Jacques Cartier
Massy, 91300
Philippe Garot, Dr, p.garot@icps.com.fr
- Not yet recruiting
Clinique Pont de Chaume
Montauban, 82000
Romain André, Dr, romain-andre@hotmail.fr
- Recruiting
Hôpital Privé du Confluent
Nantes, 44277
Ashok Tirouvanziam, Dr, ashok.tirouvanziam@groupeconfluent.fr
- Recruiting
Polyclinique Les Fleurs
Ollioules, 83190
La Scala, Dr
- Not yet recruiting
APHP
Paris, 75013
Gille Montalescot, Dr, gilles.montalescot@aphp.fr
- Not yet recruiting
HP Claude Galien
Quincy-sous-Sénart, 91480
Thierry Unterseeh, Dr, t.unterseeh@icps.com.fr
- Recruiting
CHU Reims
Reims, 51000
Laurent Faroux, Dr, lfaroux@chu-reims.fr
- Recruiting
Clinique Saint Hilaire
Rouen, 76000
Matthieu Godin, Dr, mgodin@clinique-sainthilaire.fr
- Not yet recruiting
CHRU Strasbourg
Strasbourg, 67091
Olivier Morel, Pr, Olivier.Morel@chru-strasbourg.fr
- Recruiting
CH de Bigorre
Tarbes, 65013
Majdi Abdennadher, Dr, mabdennadher@ch-tarbes-vic.fr
- Not yet recruiting
Clinique Pasteur
Toulouse, 31076
Didier Tchétché, Dr, dtchetche@clinique-pasteur.com
- Recruiting
Chu Toulouse
Toulouse, 31400
Thibault Lhermusier, Pr, lhermusier.t@chu-toulouse.fr
About this study
Official title: Multicenter Observatory Evaluating the Polymer-Free Sirolimus Eluting Coronary Stent System VIVO ISAR in Routine Clinical Practice (CELEBRITY Observatory)
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
- Artery Coronary Stenosis
- Being tested
- Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary InterventionDevice
The Vivo ISAR is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months post-procedure
Secondary outcomes (4)
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
Measured: 12 months post-procedure
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
Measured: 7 days post-procedure
Assess reperfusion
Target Lesion Revascularization at 12 months
Measured: 12 months post-procedure
• Evaluate the antiplatelet treatment
antiplatelet consumption during 1 year after the procedure
Measured: 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start29 Nov 2023
- Primary completion29 Nov 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artery Coronary StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Translumina GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Responsible party
- Sponsor
- Investigators
- Thibault Lhermusier, Pr, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420505
- Sponsor's protocol ID
- TRANSLUMINA
- Acronym
- CELEBRITY
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Observatory Evaluating the Polymer-Free Sirolimus Eluting Coronary Stent System VIVO ISAR in Routine Clinical Practice (CELEBRITY Observatory)
- ClinicalTrials.gov ID
- NCT06420505
- Acronym / sponsor ID
- CELEBRITY / TRANSLUMINA
- Conditions
- Artery Coronary Stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Translumina GmbHIndustry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 29 Nov 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (6 listed)
- ≥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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Coronary InterventionThe Vivo ISAR is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease. | Device | – |
Primary outcome
rate of target lesion failure
Time frame: 12 months post-procedure
• 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
4 secondary outcomes
Device success rate
Time frame: 12 months post-procedure
Procedural success rate
Time frame: 7 days post-procedure
Assess reperfusion
Time frame: 12 months post-procedure
• Evaluate the antiplatelet treatment
Time frame: 12 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thibault Lhermusier, Pr principal investigator
University Hospital, Toulouse
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Artery Coronary Stenosis, run by Translumina GmbH at 19 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Béatrice GODEFROY (0623822906 ext. +33, beatrice.godefroy@translumina.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of target lesion failure (time frame: 12 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.