Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-01-26 @ 5:37 PM
Study NCT ID:
NCT03151018
Status:
UNKNOWN
Last Update Posted:
2017-05-12
First Post:
2016-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect and Efficacy of Onyx™, Zotarolimus-eluting Stent for Coronary Atherosclerosis
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2017-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOST-ONYX
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.
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.
Detailed Description:
Secondary endpoints are
1. Stent thrombosis-24 hours(acute), 30 days(subacute), 1 year(late), every 1 year till 3 years(very-late) after index PCI (percutaneous coronary intervention),
2. Target vessel failure
3. Composite rate of cardiac death and any MI, 3 years
4. Composite rate of all death and any MI
5. Composite rate of all death, any MI, and any repeat revascularization
6. Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy
7. Clinical device and procedural success
1. Stent thrombosis-24 hours(acute), 30 days(subacute), 1 year(late), every 1 year till 3 years(very-late) after index PCI (percutaneous coronary intervention),
2. Target vessel failure
3. Composite rate of cardiac death and any MI, 3 years
4. Composite rate of all death and any MI
5. Composite rate of all death, any MI, and any repeat revascularization
6. Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy
7. Clinical device and procedural success
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: