Randomized Study To evaluate the safety and effectiveness of the Elixir Medical DESyne Novolimus-Eluting Coronary Stent System with Durable Polymer through the assessment of clinical, angiographic and IVUS endpoints as compared to the concurrently enrolled Medtronic Zotarolimus-Eluting Coronary Stent System in a randomized, single blind study of up to 200 male and female patients. In a Continued Access Registry of up to 100 patients receiving the DESyne Stent clinical-only endpoints will be evaluated. To evaluate the safety and effectiveness of the Elixir Novolimus-Eluting Coronary Stent System with bioabsorbable polymer as compared to the Medtronic Endeavor Zotarolimus-Eluting Coronary Stent System control through clinical and angiographic endpoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
360
coronary stent implantation
coronary stent implantation
coronary stent implantation
Monash Medical Center
Melbourne, Australia
University Hospital Gent
Ghent, Belgium
Instituto Dante Pazzanese
São Paulo, Brazil
Universitäres Herz- und Gefäßzentrum
Hamburg, Germany
Thoraxcentrum
Rotterdam, Netherlands
Auckland City Hospital
Auckland, New Zealand
Jagiellonian University
Krakow, Poland
University Hospital Bern
Bern, Switzerland
In-stent late lumen loss assessed by QCA
Time frame: 9 months
Device-oriented Composite Endpoints
Time frame: 1, 6, 9, and 12 months and annually to 5 years
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