Status:
UNKNOWN
BIOFLOW-III UK Satellite Registry Orsiro Stent System
Lead Sponsor:
Biotronik UK Ltd.
Conditions:
Coronary Artery Diseases
Eligibility:
All Genders
18+ years
Brief Summary
Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry.
Detailed Description
For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complic...
Eligibility Criteria
Inclusion
- Symptomatic coronary artery disease
- Subject 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
- Subject did not sign informed consent for data release
- Pregnancy
- Known intolerance to aspirin, clopidogrel, Ticlopidine, heparin or any other anticoagulant/antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media
- Planned surgery within 6 months after PCI unless dual antiplatelet therapy will be maintained
- Currently participating in another study and primary endpoint not reached yet
Key Trial Info
Start Date :
November 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT02257710
Start Date
November 1 2015
End Date
December 1 2018
Last Update
October 2 2017
Active Locations (4)
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1
Royal Sussex County Hospital
Brighton, East-Sussex, United Kingdom, BN2 5BE
2
St Peter's Hospital
Chertsey, Surrey, United Kingdom, KT16 0PZ
3
University Hospital Southampton
Southampton, United Kingdom
4
Royal Cornwall Hospital
Truro, United Kingdom