NCT04555174Active, not recruiting
BIOFLOW-VIII All-comers Orsiro Mission Safety and Performance Registry
BIOTRONIK - SaFety and Performance Registry for an aLl-comers Subject Population With the Limus Eluting Orsiro Mission Stent System Within Daily Clinical Practice: BIOFLOW-VIII
Source: ClinicalTrials.gov · Last updated 21 Jun 2024
Brief summary (registry, in English)
The BIOFLOW-VIII registry is a post-market clinical evaluation of the Orsiro Mission stent in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 872 (actual)
- First submitted
- 2 Sept 2020
- Start date
- 25 Sept 2020
- Primary completion date
- 18 Jan 2023
- Lead sponsor
- Biotronik AG
- Diseases
- Coronary artery disease
- NCT number
- NCT04555174
What you commit to
- Study type: Observational
- Participants enrolled: 872
- From 25 Sept 2020 to the primary completion date, 18 Jan 2023
- 41 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
- Known allergy (which cannot be pre-treated) to all types of P2Y12 inhibitor (Clopidogrel, Ticagrelor, Prasugrel, Ticlopidine and Cangrelor; thus preventing the use of the appropriate P2Y12 inhibitor), aspirin, both heparin and bivalirudin, L-605 cobalt- chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten, nickel), silicon carbide, PLLA, mTOR inhibiting drugs such as sirolimus, or contrast media
Other
- Subject did not sign informed consent for data release
- Pregnancy
Who the study is looking for
- Symptomatic coronary artery disease intended to be treated with an Orsiro Mission DES (silent ischemia is permitted)
- Subject has signed informed consent for data release
- Subject is geographically stable and willing to participate at all follow up assessments
- Subject is ≥ 18 years of age
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (41)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinique Esquirol Saint Hilaire Coordinator of this site? Confirm its status | Agen | France | Unknown status |
| Clinique Axium Coordinator of this site? Confirm its status | Aix-en-Provence | France | Unknown status |
| CH Antibes Coordinator of this site? Confirm its status | Antibes | France | Unknown status |
| CH de Bastia Coordinator of this site? Confirm its status | Bastia | France | Unknown status |
| GCS de cardiologie Coordinator of this site? Confirm its status | Bayonne | France | Unknown status |
| Clinique Convert Coordinator of this site? Confirm its status | Bourg-en-Bresse | France | Unknown status |
| Hôpital Privé Saint Martin Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| CHU de Cermont Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| CH Sud Francilien Coordinator of this site? Confirm its status | Corbeil-Essonnes | France | Unknown status |
| CHU Henri Mondor Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| Centre de cardiologie d'Evecquemont Coordinator of this site? Confirm its status | Évecquemont | France | Unknown status |
| Clinique Mutualiste Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| CH d'Haguenau Coordinator of this site? Confirm its status | Haguenau | France | Unknown status |
| Clinique Sainte Clotilde Coordinator of this site? Confirm its status | La Réunion | France | Unknown status |
| Centre Hospitalier de La Rochelle Coordinator of this site? Confirm its status | La Rochelle | France | Unknown status |
| Hopital Louis Pasteur Coordinator of this site? Confirm its status | Le Coudray | France | Unknown status |
| Hopital Prive de L Estuaire Coordinator of this site? Confirm its status | Le Havre | France | Unknown status |
| Hôpital Marie Lannelongue Coordinator of this site? Confirm its status | Le Plessis-Robinson | France | Unknown status |
| CH de METZ Coordinator of this site? Confirm its status | Metz | France | Unknown status |
| Clinique Pont de Chaume Coordinator of this site? Confirm its status | Montauban | France | Unknown status |
| Clinique du Millenaire Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Clinique du Diaconat Coordinator of this site? Confirm its status | Mulhouse | France | Unknown status |
| Hôpital Privé du Confluent Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Clinique Ambroise Pare Coordinator of this site? Confirm its status | Neuilly-sur-Seine | France | Unknown status |
| Polyclinique Les Fleurs Coordinator of this site? Confirm its status | Ollioules | France | Unknown status |
| Hopital Saint Joseph Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Lariboisière Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CH de Pau Coordinator of this site? Confirm its status | Pau | France | Unknown status |
| Clinique La Croix Du Sud Coordinator of this site? Confirm its status | Quint-Fonsegrives | France | Unknown status |
| Polyclinique Saint Laurent Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| Centre Cardiologique du Nord Coordinator of this site? Confirm its status | Saint-Denis | France | Unknown status |
| Nouvel Hôpital Civil Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| Clinique Rhéna / GERC Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| CH de Toulon Coordinator of this site? Confirm its status | Toulon | France | Unknown status |
| CH De Tourcoing Coordinator of this site? Confirm its status | Tourcoing | France | Unknown status |
| CHRU de Tours Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| Clinique Saint Joseph Coordinator of this site? Confirm its status | Trélazé | France | Unknown status |
| CH de Valence Coordinator of this site? Confirm its status | Valence | France | Unknown status |
| Polyclinique Vauban Coordinator of this site? Confirm its status | Valenciennes | France | Unknown status |
| CH de Vannes Coordinator of this site? Confirm its status | Vannes | France | Unknown status |
| Médpôle Lyon Villeurbanne Coordinator of this site? Confirm its status | Villeurbanne | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.