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

April 1, 2024 updated by: Boston Scientific Corporation

A Post-Approval, Single-Arm Study of the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Zhongshan Hospital Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

"all comers" study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE rate
Time Frame: 12 months
endpoints will be assessed post stent implant
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Junbo Ge, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2019

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

July 30, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (Actual)

November 9, 2018

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2424

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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