At a glance
ClinicalIndex Comparison RecordN/ACompleted· 536 enrolled
Drug / intervention
XIENCE PRIME - Long Length (LL) +1 moredevice
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 PRIME Everolimus Eluting Coronary Stent Post Marketing Surveillance (PMS) in Japan
In Brief
An observational study evaluating XIENCE PRIME - Long Length (LL) and XIENCE PRIME - Core Size for Angina and 4 related conditions. Completed, enrolled 536 participants across 1 site.
Detailed Summary
The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAngina, Coronary Occlusion, Coronary Artery Disease, Coronary Artery Stenosis, Myocardial Ischemia
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2012
First PostedNov 2012
Primary CompletionJun 2014
Study CompletionNov 2018
TodayJul 2026
First PostedNov 5, 2012
Enrollment StartOct 1, 2012
Primary CompletionJun 1, 2014
Study CompletionNov 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.7 years ago
Interventions
XIENCE PRIME - Long Length (LL)device
Long Length
XIENCE PRIME - Core Sizedevice
Core Size