At a glance
ClinicalIndex Comparison RecordN/ACompleted· 2,010 enrolled
Drug / intervention
XIENCE V / PROMUS stentdevice
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.
XIENCE V/PROMUS Everolimus-Eluting Stent System Japan Post-marketing Surveillance Protocol
In Brief
An observational study evaluating XIENCE V / PROMUS stent for Angina and 8 related conditions. Completed, enrolled 2,010 participants across 47 sites.
Detailed Summary
The objectives of this post-marketing surveillance, conducted in Japan, is to know the frequency, type and degree of device malfunction, to assure the safety of the medical device, and to collect information on evaluation of the efficacy and safety.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAngina, Chronic Coronary Occlusion, Stent Thrombosis, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2010
First PostedMar 2010
Primary CompletionJun 2012
Study CompletionAug 2016
TodayJul 2026
First PostedMar 15, 2010
Enrollment StartMar 1, 2010
Primary CompletionJun 1, 2012
Study CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.3 years ago
Interventions
XIENCE V / PROMUS stentdevice
Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.