At a glance
ClinicalIndex Comparison RecordN/ACompleted· 400 enrolled
Drug / intervention
XIENCE PRIME®/XIENCE Xpedition™ +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.
A Clinical Evaluation of AVJ-301 (Absorb™ BVS), the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions in Japanese Population
In Brief
A clinical study evaluating XIENCE PRIME®/XIENCE Xpedition™ and Absorb™ BVS for Coronary Artery Disease and Myocardial Ischemia. Completed, enrolled 400 participants across 39 sites.
Detailed Summary
Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter, Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions in Japanese population by comparing to approved metallic drug eluting stent.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease, Myocardial Ischemia
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2013
First PostedMay 2013
Primary CompletionJan 2015
Study CompletionJan 2019
TodayJul 2026
First PostedMay 1, 2013
Enrollment StartApr 1, 2013
Primary CompletionJan 1, 2015
Study CompletionJan 16, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.2 years ago
Interventions
XIENCE PRIME®/XIENCE Xpedition™device
Subjects receiving XIENCE PRIME®/XIENCE Xpedition™
Absorb™ BVSdevice
Subjects receiving Absorb™ BVS