Status:
COMPLETED
BIOFLOW-III Belgium Satellite Registry
Lead Sponsor:
Biotronik Belgium NV
Conditions:
Coronary Artery Disease
Myocardial Ischemia
Eligibility:
All Genders
18+ years
Brief Summary
This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
Detailed Description
For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to long-term compl...
Eligibility Criteria
Inclusion
- Symptomatic coronary artery disease
- 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
Exclusion
- Subject did not sign informed consent for data release
- Pregnancy
- Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media
- Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained
- Currently participating in another study and primary endpoint is not reached yet.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
332 Patients enrolled
Trial Details
Trial ID
NCT01831336
Start Date
February 1 2013
End Date
June 1 2016
Last Update
September 28 2017
Active Locations (8)
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1
UCL St. Luc
Brussels, Belgium, 1200
2
Brussels Heart Center
Brussels, Belgium
3
CHU Charleroi
Charleroi, Belgium
4
Grand Hopital de Charleroi Saint Joseph
Gilly, Belgium