Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
Public ClinicalTrials.gov record NCT04175626. 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.
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 Multicenter Study to Confirm 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 - VII
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this post-approval study is to confirm that the clinical performance of the Orsiro stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V Investigational Device Exemption pivotal trial, as a condition of the US Food and Drug Administration (FDA) approval (P170030).
Study identification
- NCT ID
- NCT04175626
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 556 participants
Conditions and interventions
Conditions
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
- Jan 24, 2020 (Actual)
- Primary completion
- Jan 12, 2022 (Actual)
- Completion
- Jan 8, 2026 (Actual)
- Last update posted
- Feb 27, 2026
2020 – 2026
United States locations
- U.S. sites
- 33
- U.S. states
- 23
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cardiology Associates of Mobile | Fairhope | Alabama | 36532 | — |
| John Muir Medical Center | Concord | California | 94520 | — |
| St. Joseph Hospital Orange | Orange | California | 92868 | — |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| AdventHealth Tampa | Tampa | Florida | 33613 | — |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | — |
| University of Illinois | Chicago | Illinois | 60612 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Advocate Lutheran General Hospital | Park Ridge | Illinois | 60068 | — |
| Ascension St. Vincent Medical Group | Indianapolis | Indiana | 46920 | — |
| Ascension Via Christi Hospitals | Wichita | Kansas | 67226 | — |
| University of Kentucky | Lexington | Kentucky | 40536 | — |
| Northern Light Cardiology | Bangor | Maine | 04401 | — |
| MedStar Union Memorial Hospital | Baltimore | Maryland | 21218 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | — |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | — |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | — |
| Saint Michael's Medical Center | Newark | New Jersey | 07102 | — |
| Maimonides Medical Center | Brooklyn | New York | 11219 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Weill Cornell Medical College | New York | New York | 10065 | — |
| Mercy Health - St Vincent Medical Center | Toledo | Ohio | 43608 | — |
| Penn State Health Holy Spirit Medical Center | Camp Hill | Pennsylvania | 17011 | — |
| AnMed Health | Anderson | South Carolina | 29621 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Seton Medical Center Austin | Austin | Texas | 78705 | — |
| Austin Heart | Austin | Texas | 78756 | — |
| Baylor Heart and Vascular Hospital | Dallas | Texas | 75226 | — |
| UT Health Science Center | Houston | Texas | 77030 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | — |
| Charleston Area Medical Center Memorial Hospital | 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.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04175626, 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 Feb 27, 2026 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04175626 live on ClinicalTrials.gov.