NCT03916432

Brief Summary

The study aims to evaluate the safety and efficacy of biodegradable polymer sirolimus-eluting coronary stent system (HELIOS) in patients with coronary artery disease . The primary endpoint is target lesion failure, a composite endpoint of cardiac death, target vessel related myocardial infarction and clinically-driven target lesion revascularization at 1 year follow-up.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

December 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 16, 2019

Status Verified

November 1, 2018

Enrollment Period

3 years

First QC Date

April 12, 2019

Last Update Submit

April 12, 2019

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • target lesion failure (TLF)

    a composite endpoint of cardiac death, target lesion related myocardial infarction, and/or target lesion revascularization

    12 months

Secondary Outcomes (6)

  • Patient oriented composite endpoint

    1、6、12、36、60 months

  • all cause death

    1、6、12、36、60 months

  • cardiac death

    1、6、12、36、60 months

  • Myocardial infarction

    1、6、12、36、60 months

  • Stent thrombosis

    1、6、12、36、60 months

  • +1 more secondary outcomes

Study Arms (1)

Interventional group

EXPERIMENTAL

HELIOS biodegradable polymer sirolimus-eluting stents

Device: HELIOS biodegradable polymer sirolimus-eluting stents

Interventions

HELIOS biodegradable polymer sirolimus-eluting stentsDEVICE

HELIOS biodegradable polymer sirolimus-eluting stents

Interventional group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ）18-85 years old, male or non-pregnancy female; 2）Patients with coronary artery disease who match the indication of stent implantation; 3）Patients who can understand the nature of the study, agree to participate and accept clinical follow-up

You may not qualify if:

  • Patients who can not tolerate the material or medication in this study; Pregnancy or lactation women
  • Patients who had participated in another investigational drug or device trial that has not completed the primary endpoint;
  • Patients are, in the opinion of the investigator, unable to comply with the requirements of the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ling Tao

Xi’an, Shanxi, 710054, China

RECRUITING

Related Publications (3)

  • Yuan F, Chen X, Song X, Wang D, Zhang Z, Li W, Li Z, Li H, Chen X, Huo Y, Wang L, Lu C, Lu Q, Xu B, Li W, Lyu S; HOPE Investigator. Novel completed biodegradable polymer sirolimus-eluting stent versus durable polymer sirolimus-eluting stent in de novo lesions: nine-month angiographic and three-year clinical outcomes of HOPE trial. Chin Med J (Engl). 2014;127(14):2561-6.

    PMID: 25043067RESULT

  • He X, Liu Y, Yin Z, Li F, van Geuns RJ, Garg S, Onuma Y, Serruys PW, Gao C, Tao L. Mid-term outcomes of paclitaxel-coated balloon for de novo non-small coronary lesions: a pooled analysis. BMC Med. 2025 Oct 31;23(1):598. doi: 10.1186/s12916-025-04429-9.

    PMID: 41174582DERIVED

  • Zheng B, Liu Y, Zhang R, Yang W, Su F, Wang R, Chen D, Shen G, Qiu Y, Wang L, Chen C, Wu Z, Li F, Li J, Li C, Gao C, Tao L; HELIOS Investigators. A novel biodegradable polymer-coated sirolimus-eluting stent: 1-year results of the HELIOS registry. Chin Med J (Engl). 2023 Aug 5;136(15):1848-1854. doi: 10.1097/CM9.0000000000002324.

    PMID: 37306407DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Ling Tao, MD, PhD

    First Affiliated Hospital，Fourth Military Medical University

    STUDY DIRECTOR

Central Study Contacts

Yi Liu, MD, PhD

CONTACT

186029732751391643423@qq.com

Ruining Zhang, MS

CONTACT

86-029-84775183liuyimeishan@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2019

First Posted

April 16, 2019

Study Start

December 1, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2025

Last Updated

April 16, 2019

Record last verified: 2018-11

Locations

CN(1)