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PROMUS PREMIER™ China Post-Approval Study

NCT ID: NCT03273023

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2059 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-11

Study Completion Date

2025-10-03

Brief Summary

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To compile real-world clinical outcome data for the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System (Promus PREMIERTM Stent System) in routine clinical practice in China.

Detailed Description

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Each site will be allowed to enroll up to a maximum of 300 subjects. The scheduled follow up will occur at 30 days, 6 months, 12 months and then annually through 5 years post stent implant, for all enrolled subjects. Follow-up will be conducted via telephone contact or clinic visit

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System

Promus PREMIERTM Stent System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject must be at least 18 years of age
* Subject understands and provides written informed consent
* Subject who is clinically indicated and will have an attempt of at least one Promus PREMIERTM Stent OR Subject who is clinically indicated and was implanted with at least one Promus PREMIERTM Stent
* Subject is willing to comply with all protocol-required follow-up evaluation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bo Yu, Dr.

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Harbin Medical University

Locations

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The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status

Countries

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China

Other Identifiers

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S2384

Identifier Type: -

Identifier Source: org_study_id