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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UNKNOWN
1500 participants
OBSERVATIONAL
2019-04-04
2022-04-27
Brief Summary
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The purpose of the registry is to explore the safety and effectiveness of the BioFreedomTM DCS in standard clinical practice in France and to serve as part of Post Market Surveillance.
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Detailed Description
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The registry will be purely observational and will not interfere with physician's decisions relating to stent selection or indication for treatment.
The purpose of the registry is to explore the safety and effectiveness of the BioFreedomTM DCS in standard clinical practice in France and to serve as part of Post Market Surveillance.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients who have signed an Informed Consent
Exclusion Criteria
* Patients taking part in another interventional trial which has not completed follow-up for the primary endpoint .Patient has received an additional stent different from a BioFreedom™ DCS stent during the index procedure.
* Pregnant or breastfeeding women
* Planned surgery within 6 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri surgical period for non HBR patients
* Planned surgery within 1 month of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri surgical period for HBR patients
* Patients under judicial protection, tutorship or curatorship
ALL
No
Sponsors
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European Cardiovascular Research Center
NETWORK
Biosensors Europe SA
INDUSTRY
Responsible Party
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Principal Investigators
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Janusz Lipiecki, MD
Role: PRINCIPAL_INVESTIGATOR
Clinique des Dômes
Philippe Garot, MD
Role: PRINCIPAL_INVESTIGATOR
ICPS, Massy
Locations
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Clinique Des Dômes
Clermont-Ferrand, Cedex 2, France
at Hôpital Privé Claude Galien ICPS
Quincy-sous-Sénart, Essonne, France
Clinique de Fontaine
Fontaine-lès-Dijon, , France
Centre Hospitalier General
Haguenau, , France
Clinique Saint Martin
Pessac, , France
CHU Toulouse Rangeuil
Toulouse, , France
Countries
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Other Identifiers
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18-EU-01
Identifier Type: -
Identifier Source: org_study_id
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