BIOFLOW-SV All Comers Registry

Study Overview
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Brief Summary
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Assessment of the clinical safety and performance of the Orsiro drug-eluting stent in a real world setting in patients with small vessels with reference vessel diameter ≤2.75 mm.

Detailed Description
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Prospective, single-arm, multi-center, all-comers registry with clinical follow-up visits at the hospital or by phone at 6 and 12 months post-procedure. A minimum of 1000 patients will be enrolled in approximately 15 sites in Brazil, including at least 415 patients with reference vessel diameter ≤2.75 mm as assessed by online QCA.

Official Title
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BIOTRONIK - SaFety and Performance Registry for an All-comers Patient Population With the SiroLimus Eluting Orsiro Stent Within Daily Clinical Practice in Small Vessels

Conditions
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de Novo, Symptomatic Ischemic Heart Disease, Restenoses, Coronary

Intervention / Treatment
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* Device: Orsiro Sirolimus Eluting Coronary Stent System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects ≥18 years of Age Subject must sign a Patient Informed Consent (PIC) Subject must agree to undergo all required follow-up visits, either at the hospital or by phone. Subject with coronary artery disease requiring treatment with Orsiro Sirolimus eluting stent system Exclusion Criteria: Pregnant and/or breast feeding females at the time of enrolment Known allergies to Acetylsalicylic Acid (ASA), clopidogrel, ticlopidine, heparin or any other anticoagulant /antiplatelet required for PCI, contrast medium, sirolimus, or similar drugs, or the stent materials that cannot be adequately pre-medicated Currently participating in another study that has not yet reached the primary endpoint.

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

| Intervention/Treatment |
| --- |
|Device: Orsiro Sirolimus Eluting Coronary Stent System|Percutaneous coronary intervention|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure for the small vessel group | Primary endpoint will be Target Lesion Failure (TLF) at 12 months for the small vessels group, defined as a composite of cardiac death, target vessel Myocardial Infarction (MI) or clinically driven Target Lesion Revascularization (TLR) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TLF for the overall cohort | TLF at 12 months post procedure for the overall cohort | at 12 months | 
| Clinically driven Target Lesion Revascularization (TLR) | Clinically driven Target Lesion Revascularization (TLR) at 6 and 12 months post procedure | at 6 and 12 months | 
| Clinically driven Target Vessel Revascularization (TVR) | Clinically driven Target Vessel Revascularization (TVR) at 6 and 12 months post procedure | at 6 and 12 months | 
| Definite and probable stent thrombosis | Definite and probable stent thrombosis at 6 and 12 months post procedure (ARC Definition) | at 6 and 12 months | 
| Procedure success | defined as achievement of a final diameter stenosis of <30% by investigator's visual estimate (using any percutaneous method) without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay | 12 months | 
| Device success | defined as a final residual diameter stenosis of <30% by investigator's visual estimate, using the assigned device only, successful delivery of the stent to the target lesion site in the coronary artery, appropriate stent deployment, and successful removal of the device. Post-dilatation is allowed to achieve device success | 12 months |