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NCT03736226 Clinical Trial

A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China

Cardiovascular Diseases Clinical Trial

Official title:
A Post-Approval, Single-Arm Study of the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System in China

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03736226
Other study ID # S2424
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 30, 2019
Est. completion date March 31, 2028

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

Clinical Trial Summary

A prospective, observational, single-arm, open-label, multicenter, post-approval study. To compile real-world clinical outcomes data for the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGYTM Stent System) in real-world clinical practice in China.

Description:

This prospective, open-label, multi-center study is designed to provide post-market surveillance information on the SYNERGY Stent System. The study will evaluate clinical outcomes of subjects receiving the SYNERGY™ stents over 5 years in a real world setting according to post approval requirements by China government.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 2000
Est. completion date March 31, 2028
Est. primary completion date June 30, 2024
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 SYNERGYTM stent OR Subject who is clinically indicated and was implanted with at least one SYNERGYTM stent - Subject is willing to comply with all protocol-required follow-up evaluation Exclusion Criteria: - Exclusion criteria are not required in this study which is an "all comers" study.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• SYNERGYTM Stent System
no intervention design in the study

Locations
Country Name City State
China Zhongshan Hospital Fudan University Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary MACE rate endpoints will be assessed post stent implant 12 months
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