BIOFLOW-III VIP Russia Registry Orsiro Stent System
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|ClinicalTrials.gov Identifier: NCT02247492|
Recruitment Status : Recruiting
First Posted : September 25, 2014
Last Update Posted : July 23, 2018
|Condition or disease|
|Coronary Artery Diseases|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|Target Follow-Up Duration:||36 Months|
|Official Title:||BIOTRONIK - SaFety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III and Vulnerable Inflammation Parameter Registry|
|Actual Study Start Date :||April 14, 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||May 2021|
- Target Lesion Failure (TLF) [ Time Frame: 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).
- Target Lesion Failure (TLF) [ Time Frame: 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)
- Target Vessel Revascularization (TVR) [ Time Frame: 6 and 36 months ]Any repeat revascularization of the target vessel.
- Target Lesion Revascularization (TLR) [ Time Frame: 6 and 36 months ]Defined as any repeat revascularization of the target lesion.
- Stent Thrombosis [ Time Frame: 6, 12 and 36 months ]Definite, Probable and Possible Stent Thrombosis
- Clinical Device Success [ Time Frame: 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 [ Time Frame: 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.
- Vulnerable Inflammation Parameter (VIP) [ Time Frame: up to 36 months ]VIP registered ad Endotoxin concentration in patients blood serum
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247492
|Contact: Ildar Khassanov, Dr.||+49 9131 852 56 firstname.lastname@example.org|
|Ural Institute of Cardiology||Recruiting|
|Ekaterinburg, Russian Federation|
|Contact: Marina Freidlin|
|Research Institute for Complex Problems of Cardiovascular Diseases||Recruiting|
|Kemerovo, Russian Federation|
|Contact: Gonyukov, Dr.|
|Regional Clinical Hospital||Recruiting|
|Nizhniy Novgorod, Russian Federation|
|Contact: Antonina Bogush, Dr.|
|Novosibirsk Scientific Research Institute of Circulation Pathology||Recruiting|
|Novosibirsk, Russian Federation|
|Contact: Evgeniy Kretov|
|City Emergency Clinical Hospital of Rostov-on-Don||Recruiting|
|Rostov-on-Don, Russian Federation|
|Contact: Alexander Ponomarev, Dr.|
|North-West Federal Medical Research Center named after V.A. Almazov||Recruiting|
|Saint Petersburg, Russian Federation|
|Contact: Alexey Yakovlev|
|Institute of Cardiology, Tomsk Medical Research||Recruiting|
|Tomsk, Russian Federation|
|Contact: Sergey Popov|
|Principal Investigator:||Evgeny Kretov, Dr.||Novosibirsk Research Institute for Circulation|