BIOFLOW III Satellite-ELADIS Orsiro Stent System
|ClinicalTrials.gov Identifier: NCT02029092|
Recruitment Status : Completed
First Posted : January 7, 2014
Last Update Posted : September 28, 2017
|Condition or disease|
|Coronary Artery Disease|
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 neontimal 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. Results will contribute to the collection of clinical evidence for the clinical performance and safety of ORSIRO drug eluting stent system in daily clinical practice.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||404 participants|
|Target Follow-Up Duration:||12 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- ELADIS|
|Actual Study Start Date :||February 2014|
|Primary Completion Date :||July 2016|
|Study Completion Date :||July 2016|
- 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).
- TLF [ Time Frame: 6 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 Vessel Revascularization (TVR) [ Time Frame: 6 and 12 months ]Target Vessel Revascularization (TVR)
- Target lesion revascularization (TLR) [ Time Frame: 6 and 12 months ]Target lesion revascularization (TLR)
- Stent Thrombosis rate [ Time Frame: 6 and 12 months ]Stent Thrombosis rate
- Device success [ Time Frame: up to discharge ]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, without using any adjunctive device outside the assigned treatment strategy
- Procedure success [ Time Frame: up to 7 days after procedure ]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, without using any adjunctive device and without the occurrence of ischemia-driven major cardiac event during the hospital stay to a maximum of the first seven days post index procedure.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029092
|Hospital Universitario León|
|León, A/Altos de Nava s/n, Spain, 24080|
|Hospital Infanta Cristina|
|Hospital Vall D' Hebron|
|Hospital G.de Jerez de la Frontera|
|Hospital de Txagorritxu|
|Gasteiz / Vitoria, Spain|
|Hospital Univ. Virgen de la Arrixaca|
|Hospital de Mérida|
|Hospital Parc Tauli|
|Complejo de Hospitalario de Santiago|
|Santiago de Compostela, Spain, 15702|
|Hospital Virgen del Rocio|
|Hospital Mutua de Terrassa|
|Hospital Clinico de Valencia|
|Hospital Doctor Peset|
|Hospital de Cruces|
|Vizcaya, Spain, 48903|
|Study Director:||Sonia Martin||CEM BIOTRONIK SA|