At a glance
ClinicalIndex Comparison RecordN/ACompleted· 440 enrolled
Drug / intervention
Coronary 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.
BIOTRONIK-Safety and Clinical PerFormance of the Drug ELuting Orsiro Stent in the Treatment of Subjects With de Novo Coronary Artery Lesions-VI
In Brief
A clinical study evaluating Coronary Stent for Coronary Artery Disease. Completed, enrolled 440 participants across 1 site.
Detailed Summary
The clinical investigation is a non-inferiority, multicenter, blinding evaluation, randomized, parallel controlled clinical study enrolling up to 440 subjects. All subjects will be randomized 1:1 to receive the BIOTRONIK Orsiro SES or the Abbott Xience Prime™ EES, in order to evaluate the efficacy and safety of the SES drug eluting stent in the treatment of coronary artery disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesChina
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJul 2015
First PostedAug 2016
Primary CompletionApr 2017
Study CompletionDec 2021
TodayJul 2026
First PostedAug 18, 2016
Enrollment StartJul 14, 2015
Primary CompletionApr 6, 2017
Study CompletionDec 1, 2021
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.9 years ago
Interventions
Coronary Stentdevice