BIOFLOW-III All-comers Orsiro Safety and Performance Registry

Study Overview
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Brief Summary
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This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

Detailed Description
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For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to long-term complications range from rather immediate elastic recoil 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%-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%-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 immobilised 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 a 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. This observational registry 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.

Official Title
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BIOTRONIK - Safety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III

Conditions
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Myocardial Ischemia, Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic coronary artery disease Subject has signed informed consent for data release Subject is geographically stable and willing to participate at all follow-up assessments Subject is ≥ 18 years Exclusion Criteria: Subject did not sign informed consent for data release Pregnancy Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained Currently participating in another study and primary endpoint is not reached yet.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Orsiro DES<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure (TLF) |  | 6, 36 and 60 months | 
| Target Vessel Revascularization (TVR) | Any repeat revascularization of the target vessel. | 6, 12, 36 and 60 months | 
| Target Lesion Revascularization (TLR) | Any repeat revascularization of the target lesion. | 6, 12, 36 and 60 months | 
| Stent Thrombosis |  | 6, 12, 36 and 60 months | 
| Clinical Device Success |  | At time of intervention | 
| Clinical Procedural Success |  | During the hospital stay to a maximum of the first seven days post index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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International, Multicenter, Observational registry, All-comers open label registry, Orsiro Drug Eluting Stent (DES), Stenting, Treatment of Coronary Artery Disease, Coronary revascularization, Percutaneous Coronary Intervention, STEMI, NSTEMI, Ischemia, Angina, Subgroups, Acute Myocardial Infarction, Diabetes, Small Vessels, Chronic Total Occlusion (CTO)