Coronary Artery Disease
Conditions
Brief summary
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.
Interventions
DEVICEAbbott Laboratories Xience
DEVICEBiotronik Orsiro
Sponsors
Biotronik AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Vessel Failure | 12 months post index procedure |
Secondary
| Measure | 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 |
Countries
Australia, Belgium, Denmark, Germany, Israel, Japan, Netherlands, New Zealand, Poland, Spain, Sweden, Switzerland
Outcome results
None listed