BIOFLOW-VIII All-comers Orsiro Mission Safety and Performance Registry
NCT ID: NCT04555174
Last Updated: 2024-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
872 participants
OBSERVATIONAL
2020-09-25
2027-02-19
Brief Summary
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Detailed Description
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A total of 868 subjects will be enrolled at approximately 50 study sites in France. Clinical follow-ups will take place at 6, 12, 36 and 60 months post index-procedure. Follow-ups can be conducted by telephone.
A subgroup analysis will evaluate the outcomes for patients treated ambulatory with same day discharge.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Orsiro Mission DES
All subjects will be implanted with the Limus Eluting Orsiro Mission Stent System and followed up until 60 months.
Orsiro Mission DES
Percutaneous Coronary Intervention (PCI)
Interventions
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Orsiro Mission DES
Percutaneous Coronary Intervention (PCI)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Pregnancy
* 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
18 Years
ALL
No
Sponsors
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Biotronik France
INDUSTRY
Biotronik AG
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Barragan, MD
Role: PRINCIPAL_INVESTIGATOR
Polyclinique les Fleurs
Locations
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Clinique Esquirol Saint Hilaire
Agen, , France
Clinique Axium
Aix-en-Provence, , France
CH Antibes
Antibes, , France
CH de Bastia
Bastia, , France
GCS de cardiologie
Bayonne, , France
Clinique Convert
Bourg-en-Bresse, , France
Hôpital Privé Saint Martin
Caen, , France
CHU de Cermont Ferrand
Clermont-Ferrand, , France
CH Sud Francilien
Corbeil-Essonnes, , France
CHU Henri Mondor
Créteil, , France
Centre de cardiologie d'Evecquemont
Évecquemont, , France
Clinique Mutualiste
Grenoble, , France
CH d'Haguenau
Haguenau, , France
Clinique Sainte Clotilde
La Réunion, , France
Centre Hospitalier de La Rochelle
La Rochelle, , France
Hôpital Louis Pasteur
Le Coudray, , France
Hôpital Privé de l'Estuaire
Le Havre, , France
Hôpital Marie Lannelongue
Le Plessis-Robinson, , France
CH de Metz
Metz, , France
Clinique Pont de Chaume
Montauban, , France
Clinique du Millénaire
Montpellier, , France
Clinique du Diaconat
Mulhouse, , France
Hôpital Privé du Confluent
Nantes, , France
Clinique Ambroise Paré
Neuilly-sur-Seine, , France
Polyclinique Les Fleurs
Ollioules, , France
Hôpital Lariboisière
Paris, , France
Hôpital Saint Joseph
Paris, , France
CH de Pau
Pau, , France
Clinique La Croix du Sud
Quint-Fonsegrives, , France
Polyclinique Saint Laurent
Rennes, , France
Centre Cardiologique du Nord
Saint-Denis, , France
Clinique Rhéna / GERC
Strasbourg, , France
Nouvel Hopital Civil
Strasbourg, , France
CH de Toulon
Toulon, , France
CH de Tourcoing
Tourcoing, , France
CHRU de Tours
Tours, , France
Clinique Saint Joseph
Trélazé, , France
CH de Valence
Valence, , France
Polyclinique Vauban
Valenciennes, , France
CH de Vannes
Vannes, , France
Médpôle Lyon Villeurbanne
Villeurbanne, , France
Countries
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Other Identifiers
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C1902
Identifier Type: -
Identifier Source: org_study_id
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