The ABSORB II clinical trial will enroll approximately 500 patients at about 40 investigational sites in Europe and New Zealand . Patients will be randomized at a ratio of 2-to-1 (Absorb to XIENCE PRIME). The primary endpoints of the trial are change in dimension of the lumen (interior of the vessel) over time and vasomotion (vessel movement) at the treated vessel segment, which will be assessed based on changes in the vessel diameter in response to a stimulus. Clinical endpoints, including death, myocardial infarction (heart attack), target lesion revascularization, and scaffold/stent thrombosis, will be assessed at 30 and 180 days and at one, two and three years post-treatment. Quality-of-life measures will be assessed prior to treatment, at 180 days and at one, two and three years post-treatment.
Note: This is not the pivotal trial for approval of Absorb in the US or any other market.
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