PROMUS PREMIER™ China Post-Approval Study

Coronary Artery Disease Clinical Trial

Official title:

Post-Approval Study of the PROMUS PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System in China

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03273023
• Other study ID #: S2384
• Status: Active, not recruiting
• Start date: January 11, 2018
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2059
• Est. completion date: September 30, 2024
• Est. primary completion date: December 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System
Promus PREMIERTM Stent System

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12-month Primary Endpoint: Major Adverse Cardiac Event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)	The primary endpoint is the 12-month major adverse cardiac event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)	12-month follow up