Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus-eluting Stent

Study Overview
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Brief Summary
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BIOFLOW-IV is a prospective, international, multicenter, randomised controlled trial. The purpose of this trial is to compare the Biotronik Orsiro drug eluting stent system with the Xience Prime / Xience Xpedition (Xience)drug eluting stent system in de novo coronary lesions. The study is powered for non-inferiority with respect to Target Vessel Failure(TVF)at 12 months.

Official Title
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BIOTRONIK-A Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Stent in the Treatment of Subjects With up to Two de Novo Coronary Artery Lesions - IV

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Abbott Laboratories Xience
* Device: Biotronik Orsiro


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Subject must provide written informed consent The target reference vessel diameter (RVD) is ≥ 2.50 mm and ≤ 3.75 mm assessed either visually or by online QCA. Target lesion length is ≤ 26 mm (assessed either visual estimate or by online QCA) and can be covered by one study stent Single de novo lesion with ≥ 50% and < 100% stenosis in up to 2 coronary arteries Main Exclusion Criteria: Subject has evidence of myocardial infarction within 72 hours prior to the index procedure Planned intervention of non-target vessel(s) within 30 days after the index procedure Planned intervention of target vessel(s) after the index procedure Target lesion is located in the left main Target lesion is located in or supplied by an arterial or venous bypass graft Target lesion involves a side branch > 2.0 mm in diameter by visual estimate or by online QCA Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Abbott Laboratories Xience<br>Subjects assigned to Abbott Laboratories Xience can be treated with either the Xience Prime or Xience Xpedition drug eluting stent (DES). | Device: Abbott Laboratories Xience<br> <br> |
| Experimental: Biotronik Orsiro<br>Subjects assigned to Biotronik Orsiro will be treated with Biotronik Orsiro | Device: Biotronik Orsiro<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Vessel Failure |  | 12 months post index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinically-driven target lesion revascularization (TLR) |  | 1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year | 
| Rate of clinically-driven target vessel revascularization (TVR) |  | 1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year | 
| Rate of target lesion failure (TLF), defined as composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI), emergent coronary artery bypass graft (CABG), any clinically-driven TLR |  | 1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year |