Effect and Efficacy of Onyx™, Zotarolimus-eluting Stent for Coronary Atherosclerosis
HOST-ONYX
Harmonizing Optimal Strategy for Treatment of Coronary Atherosclerotic Lesions - Registry-based Study on the Effect and Safety of Onyx™, Zotarolimus-eluting Stent for Coronary Atherosclerotic Lesions: HOST-Onyx Registry
1 other identifier
observational
4,000
1 country
16
Brief Summary
The objectives of this study are
- 1.To establish a prospective registry of the whole patients who received percutaneous coronary intervention with Resolute Onyx™ stent.
- 2.To evaluate the long-term efficacy and safety of coronary stenting with the Resolute Onyx™ stent.
- 3.To compare the long-term efficacy and safety of coronary stenting between the Resolute Onyx™ stent and other contemporary drug-eluting stents which had established their own registry.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2015
Longer than P75 for all trials
16 active sites
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
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 21, 2016
CompletedFirst Posted
Study publicly available on registry
May 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedMay 12, 2017
May 1, 2017
3 years
July 21, 2016
May 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Target lesion failure
Composite of cardiac death, non-fatal target vessel-related myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)
12 months
Secondary Outcomes (10)
Stent thrombosis, acute
within 24 hours after index PCI
Stent thrombosis, subacute
from 24 hours to 30 days after index PCI
Stent thrombosis, late
from 30 days to 1 year after index PCI
Stent thrombosis, very-late
1 year ~ up to 3 years
Target vessel failure
12 months
- +5 more secondary outcomes
Study Arms (1)
Onyx
The patients who received PCI with Resolute Onyx stent(s)
Interventions
Eligibility Criteria
All coronary arterial disease patients who received percutaneous coronary intervention with Resolute Onyx™ stent(s)
You may qualify if:
- Age above 19
- Patients who received PCI with Resolute Onyx™ stent(s)
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Medtroniccollaborator
Study Sites (16)
Kosin University Gospel Hospital
Busan, South Korea
Soon Chun Hyang University Hospital Cheonan
Cheonan, South Korea
Myongji Hospital
Goyang, South Korea
Gwangju Christian Hospital
Gwangju, South Korea
Kwangju Veterans Hospital
Gwangju, South Korea
Chungbuk National University Hospital
Jeonju, South Korea
Presbyterian Medical Center
Jeonju, South Korea
Gyeongsang National University Hospital
Jinju, South Korea
Pusan National University Hospital
Pusan, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Gangbuk Samsung Hospital
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Soonchunhyang University Hospital
Seoul, South Korea
St. Vincent's Hospital
Suwon, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hyo-soo Kim, MD, PhD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 21, 2016
First Posted
May 12, 2017
Study Start
May 1, 2015
Primary Completion
May 1, 2018
Study Completion
May 1, 2021
Last Updated
May 12, 2017
Record last verified: 2017-05