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

NCT01894152 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2002

Last updated 2020-05-26

Study results available
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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.

Conditions

Interventions

DEVICE

XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Junbo Ge, MB, MSc, MD · Fudan University

  • Fang Chen, MD · Anzhen Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2019-10-09
Completion
2019-10-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01894152 on ClinicalTrials.gov