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Active, not recruiting Observational

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

NCT03736226 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2019-07-30
Last updated
2026-10-27

Condition(s) studied

Cardiovascular Diseases

Investigational drug(s) / intervention(s)

SYNERGYTM Stent System

SYNERGYTM Stent System: no intervention design in the study

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • MACE rate — 12 months
    endpoints will be assessed post stent implant

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Hospital Fudan University Shanghai Shanghai Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03736226 on ClinicalTrials.gov ↗ ← All trials in China