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NCT01677585 Clinical Trial

Post-Approval Study of PROMUS Element™ in China

Coronary Artery Disease Clinical Trial

— PEChina  

Official title:
PROMUS Element™ China Post-Approval Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01677585
Other study ID # S2288
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2012
Est. completion date December 2019

Study information
Verified date February 2022
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to compile real-world clinical outcomes data for the PROMUS Element™ and PROMUS Element™ Plus Everolimus-Eluting Coronary Stent System (PROMUS Element and PROMUS Element Plus Stent System) in routine clinical practice in China.

Description:

Everolimus-eluting stents have been studied extensively in ongoing clinical studies. The safety and effectiveness of the everolimus drug and polymer combination have been studied extensively in the SPIRIT Clinical Trial Program. The PROMUS Element stent is currently being studied in the PLATINUM Clinical Trial Program. The PROMUS Element stent is also being evaluated in PROMUS Element Plus US post-approval studies and the ongoing Platinum China study. This study is designed to provide post-market surveillance information on the PROMUS Element™ and PROMUS Element™ Everolimus-Eluting Coronary Stent System (PROMUS Element and PROMUS Element Plus Stent System) after it has been approved by SFDA (State of Food and Drug Administration) in China. The study will evaluate clinical outcomes for subjects receiving the PROMUS Element and PROMUS Element plus stents over 5 years in a real world setting according to post approval requirements from SFDA.

Recruitment information / eligibility
Status Completed
Enrollment 2016
Est. completion date December 2019
Est. primary completion date December 2015
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 Element stent OR Subject who is clinically indicated and was implanted with at least one PROMUS Element stent - Subject is willing to comply with all protocol-required follow-up evaluation Exclusion Criteria: - Exclusion criteria is not required in the PROMUS Element China Post-Approval study which is an "all comers" study.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Second Affliated Hosptial Zhejiang University College of Medicine Hangzhou

Sponsors (1)
Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Target Lesion Failure (TLF) rate The primary endpoint is the 12-month target lesion failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death. 12-month
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