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NCT01894152 · ClinicalTrials.gov registry record

XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study

A clinical trial, sponsored by Abbott Medical Devices.

Completed
Registry status
2,002
Enrollment target

NCT01894152: Completed study, sponsored by Abbott Medical Devices.

NCT01894152 is a clinical trial that has completed, run by Abbott Medical Devices. The registered enrollment target is 2,002 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01894152 has completed, sponsored by Abbott Medical Devices.

COMPLETED
Registry status
2,002 participants
Enrollment target

Study Summary

Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug Administration (CFDA) on August 10th, 2011. This prospective, observational, open-label, multi-center, single-arm, post-approval study is designed to evaluate the continued safety and effectiveness of the XIENCE PRIME EECSS in a cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in real-world settings in China. This study has no primary outcome measure. All observations are of equal weight.

Primary Outcome

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infa

Interventions

  • DEVICE XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

Trial Details

FieldValue
Enrollment Target 2,002 participants
Start Date 2013-07
Est. Completion 2019-10-09
Abbott Medical Devices

261 total trials

What the finished NCT01894152 record still lists

NCT01894152 is an observational study that tracks outcomes without assigning an intervention. Its 2,002 participants enrollment target places it among the larger protocols in the corpus.

The record links to 0 conditions, and to 1 intervention - of which XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) is the first listed.

NCT01894152 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01894152 about?

NCT01894152 is a clinical study titled "XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study". Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug Administration (CFDA) on August 10th, 2011. This prospective, observational, open-label, multi-center, single-arm, post-approval ...

What is the current status of trial NCT01894152?

This trial is currently completed. The enrollment target is 2,002 participants. The study started on 2013-07. Estimated completion is 2019-10-09.

What interventions are being tested in trial NCT01894152?

The interventions under investigation include: XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) (DEVICE).

Who is sponsoring clinical trial NCT01894152?

This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01894152, the US trial registry maintained by the National Library of Medicine. NCT01894152 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.