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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RECRUITING
10000 participants
OBSERVATIONAL
2023-06-15
2029-03-30
Brief Summary
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Detailed Description
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This registry will enroll up to 10000 patients in up to 150 investigative centers in Europe, South America, Middle East, Asia over a period of 5 years. Each patient be followed with phone (or clinic) visit at 12 months.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Biofreedom Ultra
The BioFreedomTM Ultra CoCr DCS is a combination product consisting of two key components: the cobalt chromium stent platform coated abluminally with the active ingredient BA9TM (polymer and carrier free) and the delivery system.
Eligibility Criteria
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Inclusion Criteria
* Patient is at least 18 years old
* Patient provides a signed informed consent
Exclusion Criteria
* Patients will be excluded as per Medical Device Regulation (MDR) (Article 65: "Clinical investigations on minors" and article 66: "Clinical investigations on pregnant or breastfeeding women"
* Patients will be excluded if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision
18 Years
ALL
No
Sponsors
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European Cardiovascular Research Center
NETWORK
Biosensors Europe SA
INDUSTRY
Responsible Party
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Locations
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Royal Bournemouth hospital
Bournemouth, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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O'Kane
Role: primary
Other Identifiers
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22-EU-01
Identifier Type: -
Identifier Source: org_study_id
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