Status:
TERMINATED
BIOFLOW-III Hungary Satellite Registry
Lead Sponsor:
Biotronik Hungária Kft.
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 :
September 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2016
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT01892917
Start Date
September 1 2012
End Date
December 31 2016
Last Update
October 12 2017
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Állami Szívkórház (State Hospital for cardiology of Balatonfüred)
Balatonfüred, Hungary, 8231
2
Gottsegen György Országos Kardiológiai Intézet (Gottsegen György Hungarian Institute of Cardiology)
Budapest, Hungary, 1096
3
Bajcsy-Zsilinszky Kórház (Bajcsy-Zsilinszky Hospital)
Budapest, Hungary, 1106
4
SE ÁOK Kardiológiai Központ (Semmelweis University, Heart Center)
Budapest, Hungary, 1122