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Completed Not applicable Interventional Results available

Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions

ClinicalTrials.gov ID: NCT02389946

Public ClinicalTrials.gov record NCT02389946. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 26, 2026, 7:21 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT02389946
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Biotronik, Inc.
Industry
Enrollment
1,334 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 2015 (Type not available)
Primary completion
Apr 2017 (Actual)
Completion
Mar 2021 (Actual)
Last update posted
Aug 3, 2022

2015 – 2021

United States locations

U.S. sites
55
U.S. states
25
U.S. cities
52
Facility City State ZIP Site status
Not listed Fairhope Alabama 36535 —
Not listed Concord California 94520 —
Not listed La Mesa California 91942 —
Not listed Laguna Hills California 92653 —
Not listed Mission Viejo California 92691 —
Not listed Washington D.C. District of Columbia 20010 —
Not listed Clearwater Florida 33756 —
Not listed Hollywood Florida 33021 —
Not listed Orlando Florida 32803 —
Not listed Tampa Florida 33613 —
Not listed Atlanta Georgia 30309 —
Not listed Urbana Illinois 61801 —
Not listed Fort Wayne Indiana 46845 —
Not listed Baltimore Maryland 21218 —
Not listed Boston Massachusetts 02120 —
Not listed Bay City Michigan 48708 —
Not listed Detroit Michigan 48236 —
Not listed Lansing Michigan 48912 —
Not listed Pontiac Michigan 48341 —
Not listed Rochester Michigan 48307 —
Not listed Troy Michigan 48085 —
Not listed Ypsilanti Michigan 48197 —
Not listed Minneapolis Minnesota 55407 —
Not listed Omaha Nebraska 68124 —
Not listed Hackensack New Jersey 07601 —
Not listed Neptune City New Jersey 07753 —
Not listed Newark New Jersey 07102 —
Not listed New York New York 10021 —
Not listed New York New York 10029 —
Not listed New York New York 10032 —
Not listed Asheville North Carolina 28803 —
Not listed Greensboro North Carolina 27401 —
Not listed Fargo North Dakota 58102 —
Not listed Cincinnati Ohio 45219 —
Not listed Cleveland Ohio 44111 —
Not listed Columbus Ohio 43210 —
Not listed Elyria Ohio 44035 —
Not listed Toledo Ohio 43606 —
Not listed Toledo Ohio 43608 —
Not listed Portland Oregon 97225 —
Not listed Butler Pennsylvania 16001 —
Not listed Mechanicsburg Pennsylvania 17050 —
Not listed Wynnewood Pennsylvania 19096 —
Not listed York Pennsylvania 17403 —
Not listed Providence Rhode Island 02906 —
Not listed Greenville South Carolina 29605 —
Not listed Rock Hill South Carolina 29732 —
Not listed Knoxville Tennessee 37934 —
Not listed Dallas Texas 75226 —
Not listed Houston Texas 77030 —
Not listed McKinney Texas 75069 —
Not listed Tyler Texas 75701 —
Not listed Charlottesville Virginia 22908 —
Not listed Virginia Beach Virginia 23454 —
Not listed Charleston West Virginia 25304 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 37 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02389946, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 3, 2022 · Synced Oct 26, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02389946 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →