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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-30

Study Completion Date

2028-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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SYNERGYTM Stent System

no intervention design in the study

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Junbo Ge

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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S2424

Identifier Type: -

Identifier Source: org_study_id