BIOTRONIK - BIOFLOW-III Registry French Satellite
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|ClinicalTrials.gov Identifier: NCT02273648|
Recruitment Status : Active, not recruiting
First Posted : October 24, 2014
Last Update Posted : December 14, 2017
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.
|Condition or disease||Intervention/treatment|
|Coronary Artery Diseases||Device: Drug Eluting Stent (DES)|
|Study Type :||Observational|
|Actual Enrollment :||1000 participants|
|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 French Satellite|
|Actual Study Start Date :||November 19, 2014|
|Actual Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||September 2021|
Subjects requiring coronary revascularization with Drug Eluting Stents (DES) as well as Subjects presenting with
Device: Drug Eluting Stent (DES)
Percutaneous Coronary Intervention
- 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, 24, 36, 48 and 60 months ]Defined as the composite of Cardiac death, Target vessel Q-wave or non-Q wave Myocardial Infarction (MI) (i.e., Q-wave MI that cannot be attributed to a non-target vessel), clinically driven Target Lesion Revascularization (TLR) and Emergent Coronary Artery Bypass Grafting (CABG).
- Target Vessel Revascularization (TVR) [ Time Frame: 6, 12, 24, 36, 48 and 60 months ]Any repeat revascularization of the target vessel. (Vascular bypass or angioplasty)
- Target Lesion Revascularization (TLR) [ Time Frame: 6, 12, 24, 36, 48 and 60 months ]Target Lesion Revascularization (Vascular bypass or angioplasty)
- Stent Thrombosis [ Time Frame: 6, 12, 24, 36, 48 and 60 months ]Definite, Probable and Possible Stent Thrombosis
- Clinical Device Success [ Time Frame: up to 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 a 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 (this includes successful delivery and deployment of multiple overlapping stents, if applicable) and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% of the target lesion as observed by visual estimate without using any adjunctive device* without the occurrence of ischemia-driven major adverse cardiac event (ID-MACE) during the hospital stay to a maximum of the first seven days post index procedure.
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): NCT02273648
|Study Director:||Nicolas CANOT||Biotronik France|