BIOFLOW-III VIP Russia Registry Orsiro Stent System
- Conditions
- Coronary Artery Diseases
- Registration Number
- NCT02247492
- Lead Sponsor
- Biotronik Russia
- 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, whether the patient's body inflammation status correlates with the clinical outcome.
- 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 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Target Lesion Failure (TLF) 12 months 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).
- Secondary Outcome Measures
Name Time Method Clinical Device Success participants will be followed for the duration of hospital stay, an expected average of 1 day 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.
Clinical procedural success up to seven days 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.Target Vessel Revascularization (TVR) 6 and 36 months Any repeat revascularization of the target vessel.
Target Lesion Revascularization (TLR) 6 and 36 months Defined as any repeat revascularization of the target lesion.
Target Lesion Failure (TLF) 6 and 36 months 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)
Stent Thrombosis 6, 12 and 36 months Definite, Probable and Possible Stent Thrombosis
Vulnerable Inflammation Parameter (VIP) up to 36 months VIP registered ad Endotoxin concentration in patients blood serum
Trial Locations
- Locations (7)
Regional Clinical Hospital
🇷🇺Nizhniy Novgorod, Russian Federation
Ural Institute of Cardiology
🇷🇺Ekaterinburg, Russian Federation
Novosibirsk Scientific Research Institute of Circulation Pathology
🇷🇺Novosibirsk, Russian Federation
Research Institute for Complex Problems of Cardiovascular Diseases
🇷🇺Kemerovo, Russian Federation
City Emergency Clinical Hospital of Rostov-on-Don
🇷🇺Rostov-on-Don, Russian Federation
North-West Federal Medical Research Center named after V.A. Almazov
🇷🇺Saint Petersburg, Russian Federation
Institute of Cardiology, Tomsk Medical Research
🇷🇺Tomsk, Russian Federation