At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 60 enrolled
Drug / intervention
PROMUS Elementdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of a Small Vessel De Novo Coronary Artery Lesion in Japan
In Brief
A Phase 3 clinical trial evaluating PROMUS Element for Atherosclerosis and Coronary Artery Disease. Completed, enrolled 60 participants across 15 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtherosclerosis, Coronary Artery Disease
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2010
First PostedMar 2010
Primary CompletionMar 2011
Study CompletionDec 2012
TodayJul 2026
First PostedMar 4, 2010
Enrollment StartFeb 1, 2010
Primary CompletionMar 1, 2011
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 16.3 years ago
Interventions
PROMUS Elementdevice
PROMUS Element Everolimus-Eluting Coronary Stent System