To evaluate long-term safety and performance of the DESyne Novolimus Eluting Coronary Stent System and the DESyne BD Novolimus Eluting Coronary Stent System
DESyne and DESyne BD are not currently approved for sale in the United States.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Krankenhaus der Barmherzigen Brüder
Trier, Germany
Jordan Hospital
Amman, Jordan
King Abdullah University Hospital
Irbid, Jordan
Santiago de Compostela University Hospital Complex
Santiago de Compostela, Spain
Device-oriented Composite Endpoint (DoCE)
Device-oriented Composite Endpoint (DoCE) at 1, 9, 12, and 24 months. DoCE is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.
Time frame: 1, 9, 12, and 24 months
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