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XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study

NCT ID: NCT01249027

Last Updated: 2019-03-01

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

2605 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2017-01-31

Brief Summary

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This is a prospective, observational, single-arm, open-label, multicenter, postapproval registry study in China. The purpose of this study is to:

* Evaluate the continued safety and effectiveness of the XIENCE V EECSS in a cohort of real-world patients receiving the XIENCE V EECSS during commercial use
* Evaluate patient compliance to dual antiplatelet therapy (DAPT)

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Detailed Description

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Conditions

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Angioplasty Chronic Coronary Occlusion Stent Thrombosis Vascular Disease Myocardial Ischemia Coronary Artery Stenosis Coronary Disease Coronary Artery Disease Coronary Restenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational

Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS).

XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)

Intervention Type DEVICE

Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.

Interventions

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XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)

Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* The patient or patient's legally-authorized representative agrees to participate in this study by signing the Ethics Committee-approved informed consent form (ICF).
* Only XIENCE V stent(s) is/are implanted into the coronary vasculature during the index procedure.

Exclusion Criteria

* The inability to obtain a signed ICF
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Junbo Ge, MB, MSc, MD, FACC, FESC, FSCAI

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Jiyan Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Cardiovascular Guangdong, Guangdong Provincial People's Hospital

YuJie Zhou, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

An Zhen Hospital

Locations

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Abbott Vascular

Santa Clara, California, United States

Site Status

Countries

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United States

Other Identifiers

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10-388

Identifier Type: -

Identifier Source: org_study_id

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