An observational study in Coronary Artery Diseases, sponsored by Biotronik Russia. Status unknown at 7 sites in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-23.
Sponsored by Biotronik Russia · Observational
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, whether the patient's body inflammation status correlates with the clinical outcome.
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 complications range from rather immediate elastic coil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to 50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20 to 40% of cases, necessitating repeat procedures.
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.
5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.
This study's planned enrollment of 200 is below the median of 336 across 1,946 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →This is the only study on the registry with Biotronik Russia as lead sponsor.
Counted across the registry records on this site, refreshed daily.
All subjects requiring coronary revascularization with Drug Eluting Stents (DES)
Exclusion Criteria:
Target Lesion Failure (TLF)
Composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) and clinically driven Target Lesion Revascularization (TLR).
Time frame: 12 months
Target Lesion Failure (TLF)
Composite of cardiac death, target vessel Q-wave or non-Q wave Myocardial Infarction (MI), Emergent Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularization (TLR)
Time frame: 6 and 36 months
Target Vessel Revascularization (TVR)
Any repeat revascularization of the target vessel.
Time frame: 6 and 36 months
Target Lesion Revascularization (TLR)
Defined as any repeat revascularization of the target lesion.
Time frame: 6 and 36 months
Stent Thrombosis
Definite, Probable and Possible Stent Thrombosis
Time frame: 6, 12 and 36 months
Clinical Device Success
Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation and without use of device outside the assigned treatment strategy.
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 day
Clinical procedural success
Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation and without using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event during the hospital stay to a maximum of the first seven days post index procedure. In case of multiple lesions treatment, all treated lesions must meet the clinical procedural success.
Time frame: up to seven days
Vulnerable Inflammation Parameter (VIP)
VIP registered ad Endotoxin concentration in patients blood serum
Time frame: up to 36 months
This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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