NCT06420505Recruiting
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)
Source: ClinicalTrials.gov · Last updated 6 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 14 May 2024
- Start date
- 29 Nov 2023
- Primary completion date
- 29 Nov 2026
- Lead sponsor
- Translumina GmbH
- Diseases
- Coronary artery disease
- NCT number
- NCT06420505
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 29 Nov 2023 to the primary completion date, 29 Nov 2026
- 19 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in another clinical trial.
- Planned elective surgery in next 6 months
- Concurrent medical condition with a life expectancy of less than 12 months
Other illness
- History of cerebrovascular accident in the last 6 months.
Other
- Having benefited from an angioplasty of ≤ 1 month with a stent other than Vivo ISAR.
- Cardiogenic shock/ hemodynamically unstable patients
- Vulnerable patient under guardianship or curatorship
Who the study is looking for
- ≥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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinique Axium Coordinator of this site? Confirm its status | Aix-en-Provence | France | Recruiting |
| CHU Caen Coordinator of this site? Confirm its status | Caen | France | Not yet recruiting |
| Hôpital A. Schweitzer - GHCA Coordinator of this site? Confirm its status | Colmar | France | Recruiting |
| Clinique Louis Pasteur Coordinator of this site? Confirm its status | Essey-lès-Nancy | France | Recruiting |
| CH Haguenau Coordinator of this site? Confirm its status | Haguenau | France | Recruiting |
| Hôpital Nord Coordinator of this site? Confirm its status | Marseille | France | Not yet recruiting |
| CHU La Timone Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| HP Jacques Cartier Coordinator of this site? Confirm its status | Massy | France | Recruiting |
| Clinique Pont de Chaume Coordinator of this site? Confirm its status | Montauban | France | Not yet recruiting |
| Hôpital Privé du Confluent Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Polyclinique Les Fleurs Coordinator of this site? Confirm its status | Ollioules | France | Recruiting |
| APHP Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| HP Claude Galien Coordinator of this site? Confirm its status | Quincy-sous-Sénart | France | Not yet recruiting |
| CHU Reims Coordinator of this site? Confirm its status | Reims | France | Recruiting |
| Clinique Saint-Hilaire Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
| CHRU Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Not yet recruiting |
| CH de Bigorre Coordinator of this site? Confirm its status | Tarbes | France | Recruiting |
| Clinique Pasteur Coordinator of this site? Confirm its status | Toulouse | France | Not yet recruiting |
| CHU Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.