PROMUS Element Japan Small Vessel Trial
PROMUS Element Japan Small Vessel Trial
NCT ID: NCT01080261 Phase: PHASE3 Status: COMPLETED Enrollment: 60 Completion: 2012-12
Conditions
Atherosclerosis, Coronary Artery Disease
Interventions
PROMUS Element
Summary
A non-randomized, small vessel (SV) trial at approximately 15 sites in Japan to enroll 60 patients with a de novo lesion ≤28 mm in length (by visual estimate) in a native coronary artery ≥2.25 mm to \<2.50 mm in diameter (by visual estimate). Approximately thirty patients will be randomly assigned to the angiographic subset to also undergo angiographic assessment after the 12-month clinical follow-up.
Primary Outcome
Major Adverse Cardiac Events (MACE) (Percentage of Participants With an Event)