NCT03736226

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Jul 2019Mar 2028

First Submitted

Initial submission to the registry

July 30, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

July 30, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Expected
Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

5 years

First QC Date

July 30, 2018

Last Update Submit

May 28, 2026

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • MACE rate

    endpoints will be assessed post stent implant

    12 months

Interventions

SYNERGYTM Stent SystemDEVICE

no intervention design in the study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

"all comers" study.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Junbo Ge

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2018

First Posted

November 9, 2018

Study Start

July 30, 2019

Primary Completion

August 1, 2024

Study Completion (Estimated)

March 31, 2028

Last Updated

May 29, 2026

Record last verified: 2026-05

Locations

CN(1)