PROMUS PREMIER™ China Post-Approval Study

Boston Scientific Corporation2,059 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

2,059

Conditions

Coronary Artery Disease

Interventions

Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent SystemDEVICE

Promus PREMIERTM Stent System

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * Exclusion criteria are not required in the PE PREMIERTM China Post-Approval Study which is an "all comers" study.

Locations (1)

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Outcomes

Primary Outcomes

12-month Major Adverse Cardiac Event (MACE) Rate

12-month Major Adverse Cardiac Event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR).

Time frame: 12 months

Secondary Outcomes

12-month Cardiac Death

Participants occurred cardiac death event in 12 months

Time frame: 12 months

12-month Myocardial Infarction

Participants occurred myocardial infarction event in 12 months

Time frame: 12 months

12-month TVR

Participants occurred TVR event in 12 months

Time frame: 12 months

Data from ClinicalTrials.gov

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