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NCT02389946 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Biotronik.

Completed
Registry status
NA
Development phase
1,334
Enrollment target

NCT02389946: Completed NA study, sponsored by Biotronik.

NCT02389946 is a NA study that has completed, run by Biotronik. The registered enrollment target is 1,334 participants, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02389946, a NA study, has completed, sponsored by Biotronik.

COMPLETED
Registry status
NA
Development phase
1,334 participants
Enrollment target

Study 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.

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 Xience DES
  • DEVICE Orsiro DES

Trial Details

FieldValue
Enrollment Target 1,334 participants
Start Date 2015-05
Est. Completion 2021-03
Phase NA
Biotronik

30 total trials

What the finished NCT02389946 record still lists

NCT02389946 is an interventional study that assigns participants to a tested intervention. Its 1,334 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which Xience DES is the first listed.

NCT02389946 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02389946 about?

NCT02389946 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 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.

What is the current status of trial NCT02389946?

This trial is currently completed. It is a NA study. The enrollment target is 1,334 participants. The study started on 2015-05. Estimated completion is 2021-03.

What interventions are being tested in trial NCT02389946?

The interventions under investigation include: Xience DES (DEVICE), Orsiro DES (DEVICE).

Who is sponsoring clinical trial NCT02389946?

This trial is sponsored by Biotronik, which has 30 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02389946's enrollment target sits among peer trials

1,334 75th of 2000 higher than 1,926 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02389946, the US trial registry maintained by the National Library of Medicine. NCT02389946 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.