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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UNKNOWN
200 participants
OBSERVATIONAL
2017-04-14
2021-05-31
Brief Summary
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Detailed Description
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The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in better safety profile as compared to BMS with systemic drug administration. These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease.
Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES. It is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.
Along with it, an explanatory (hypothesis-finding) problem will be investigated, whether the patient's body inflammation status correlates with the clinical outcome.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Orsiro
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Biotronik Russia
INDUSTRY
Responsible Party
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Principal Investigators
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Evgeny Kretov, Dr.
Role: PRINCIPAL_INVESTIGATOR
Novosibirsk Research Institute for Circulation
Locations
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Research Institute for Complex Problems of Cardiovascular Diseases
Kemerovo, , Russia
Regional Clinical Hospital
Nizhny Novgorod, , Russia
Novosibirsk Scientific Research Institute of Circulation Pathology
Novosibirsk, , Russia
City Emergency Clinical Hospital of Rostov-on-Don
Rostov-on-Don, , Russia
North-West Federal Medical Research Center named after V.A. Almazov
Saint Petersburg, , Russia
Institute of Cardiology, Tomsk Medical Research
Tomsk, , Russia
Ural Institute of Cardiology
Yekaterinburg, , Russia
Countries
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Central Contacts
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Facility Contacts
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Gonyukov, Dr.
Role: primary
Antonina Bogush, Dr.
Role: primary
Evgeniy Kretov
Role: primary
Alexander Ponomarev, Dr.
Role: primary
Alexey Yakovlev
Role: primary
Sergey Popov
Role: primary
Marina Freidlin
Role: primary
Other Identifiers
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G1406
Identifier Type: -
Identifier Source: org_study_id
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