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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2002 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2019-10-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Angioplasty Cardiovascular Disease Coronary Artery Disease Coronary Heart Disease Coronary Restenosis Myocardial Infarction Stent Thrombosis Vascular Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

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

XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

Intervention Type DEVICE

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

Interventions

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XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* The patient must be at least 18 years of age at the time of signing the informed consent.
* The patient or his/her legally-authorized representative signs the European Commission (EC)-approved Informed Consent Form (ICF).
* Only XIENCE PRIME stent(s) is (are) implanted during the index procedure.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No