CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,334 enrolled
Drug / intervention
Orsiro DES +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.

Search/NCT02389946
NCT02389946N/ACompleted
CompareCT.gov

BIOTRONIK - A Prospective Randomized Multicenter Study to Assess the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions - V

Biotronik, Inc.·interventional·Posted Mar 17, 2015·Updated Aug 3, 2022

In Brief

A clinical study evaluating Orsiro DES and Xience DES for Coronary Artery Disease and 5 related conditions. Completed, enrolled 1,334 participants across 92 sites in 13 countries.

Detailed Summary

The objective of this study is to assess the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or restenotic (standard PTCA only) coronary artery lesions compared to the Xience coronary stent system.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease, Atherosclerosis, Coronary, Myocardial Ischemia, Ischemic Heart Disease, Acute Coronary Syndrome, Angina Pectoris
CountriesAustralia, Belgium, Canada, Denmark, Germany, Hungary, Israel, Netherlands, New Zealand, South Korea, Spain, Switzerland, United States
CollaboratorsBiotronik AG, Baim Institute for Clinical Research, Medstar Health Research Institute

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 17, 2015
Enrollment StartMay 1, 2015
Primary CompletionApr 1, 2017
Study CompletionMar 1, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.3 years ago

Interventions

Orsiro DESdevice

Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.

Xience DESdevice