Status:
UNKNOWN
BIOFLOW-III VIP Russia Registry Orsiro Stent System
Lead Sponsor:
Biotronik Russia
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). Along with it, an explanatory (hypothesis-finding) problem will be investigated,...
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
- 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 :
April 14 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02247492
Start Date
April 14 2017
End Date
May 1 2021
Last Update
July 23 2018
Active Locations (7)
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1
Research Institute for Complex Problems of Cardiovascular Diseases
Kemerovo, Russia
2
Regional Clinical Hospital
Nizhny Novgorod, Russia
3
Novosibirsk Scientific Research Institute of Circulation Pathology
Novosibirsk, Russia
4
City Emergency Clinical Hospital of Rostov-on-Don
Rostov-on-Don, Russia