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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 is a clinical trial that has completed, run by Biotronik. The registered enrollment target is 556 participants.
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).
Interventions
- DEVICE Orsiro DES
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 556 participants |
| Start Date | 2020-01-24 |
| Est. Completion | 2026-01-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04175626
The ClinicalTrials.gov registry entry for NCT04175626 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 556 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biotronik, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Orsiro DES is the first listed.
NCT04175626 reports 0 study locations.
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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