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NCT Number: NCT03736226

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SYNERGYTM Stent System

Device

no intervention design in the study

Primary outcomes

  1. MACE rate

    Time frame: 12 months

    endpoints will be assessed post stent implant

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2028
First posted
Nov 9, 2018
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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