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NCT04175626 · ClinicalTrials.gov registry record
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
A clinical trial, sponsored by Biotronik.
- Completed
- Registry status
- 556
- Enrollment target
NCT04175626: Completed study, sponsored by Biotronik.
NCT04175626 is a clinical trial that has completed, run by Biotronik. The registered enrollment target is 556 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04175626 has completed, sponsored by Biotronik.
- COMPLETED
- Registry status
- 556 participants
- Enrollment target
Study Summary
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).
Primary Outcome
TLF is defined as all cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (MI), or clinically driven target lesion revascularization (TLR).
Interventions
- DEVICE Orsiro DES
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 556 participants |
| Start Date | 2020-01-24 |
| Est. Completion | 2026-01-08 |
What the finished NCT04175626 record still lists
NCT04175626 is an observational study that tracks outcomes without assigning an intervention. The registered 556 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Orsiro DES is the first listed.
NCT04175626 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04175626 about?
NCT04175626 is a clinical study titled "Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions". 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 Adminis...
What is the current status of trial NCT04175626?
This trial is currently completed. The enrollment target is 556 participants. The study started on 2020-01-24. Estimated completion is 2026-01-08.
What interventions are being tested in trial NCT04175626?
The interventions under investigation include: Orsiro DES (DEVICE).
Who is sponsoring clinical trial NCT04175626?
This trial is sponsored by Biotronik, which has 30 total clinical trials registered on ClinicalTrials.gov.
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