BIOFLOW-VIII All-comers Orsiro Mission Safety and Performance Registry

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

Detailed Description
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BIOFLOW-VIII is a national, prospective, non-randomized, multi-center, open-label registry to confirm both, the acute performance as well as the mid- and long-term safety and clinical performance of the Orsiro Mission stent in an all-comers patient population within daily clinical practice. A total of 868 subjects will be enrolled at approximately 50 study sites in France. Clinical follow-ups will take place at 6, 12, 36 and 60 months post index-procedure. Follow-ups can be conducted by telephone. A subgroup analysis will evaluate the outcomes for patients treated ambulatory with same day discharge.

Official Title
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BIOTRONIK - SaFety and Performance Registry for an aLl-comers Subject Population With the Limus Eluting Orsiro Mission Stent System Within Daily Clinical Practice: BIOFLOW-VIII

Conditions
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Coronary Artery Disease, Myocardial Ischemia

Intervention / Treatment
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* Device: Orsiro Mission DES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic coronary artery disease intended to be treated with an Orsiro Mission DES (silent ischemia is permitted) 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 of age Exclusion Criteria: Subject did not sign informed consent for data release Pregnancy Known allergy (which cannot be pre-treated) to all types of P2Y12 inhibitor (Clopidogrel, Ticagrelor, Prasugrel, Ticlopidine and Cangrelor; thus preventing the use of the appropriate P2Y12 inhibitor), aspirin, both heparin and bivalirudin, L-605 cobalt- chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten, nickel), silicon carbide, PLLA, mTOR inhibiting drugs such as sirolimus, or contrast media

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 Mission DES<br>All subjects will be implanted with the Limus Eluting Orsiro Mission Stent System and followed up until 60 months. | Device: Orsiro Mission DES<br>* Percutaneous Coronary Intervention (PCI)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Target Lesion Failure (TLF) at 12 months follow-up | TLF according to Academic Research Consortium-2 (ARC-2) definition: Composite of Cardiac Death, target-vessel Myocardial Infarction and clinically-driven Target Lesion Revascularization | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Target Lesion Failure (TLF) at 6, 36 and 60 months follow-up |  | 6, 36, and 60 months | 
| Rate of Target Vessel Revascularization (TVR) at 6, 12, 36, and 60 months follow-up |  | 6, 12, 36, and 60 months | 
| Rate of Target Lesion Revascularization (TLR) at 6, 12, 36, and 60 months follow-up |  | 6, 12, 36, and 60 months | 
| Rate of Definite Stent Thrombosis at 6, 12, 36, and 60 months follow-up |  | 6, 12, 36, and 60 months | 
| Percent of participants with Clinical Device Success defined as attainment of < 30% residual stenosis of the target lesion using Orsiro Mission only |  | Immediately after the intervention/procedure/surgery | 
| Percent of participants with Clinical Procedural Success defined as attainment of < 30% residual stenosis of the target lesion using any percutaneous method without occurrence of in-hospital death, myocardial infarction or target lesion revascularization |  | From the intervention/procedure/surgery until hospital discharge, assessed up to 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Observational registry, All-comers open-label registry, Percutaneous Coronary Intervention (PCI), Coronary revascularization, Orsiro Mission Drug Eluting Stent (DES), Stenting