Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-03-06 @ 2:31 PM
Study NCT ID:
NCT01078051
Status:
TERMINATED
Last Update Posted:
2019-08-02
First Post:
2010-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total Occlusion (DECISION-CTO)
Sponsor:
Seung-Jung Park
Organization:
Study Overview
Official Title:
Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients
Status:
TERMINATED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
at sponsor's discretion : Benefit is not guaranteed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the safety and effectiveness of drug-eluting stent implantation compared to optimal medical treatment in patients with chronic total occlusion.
Detailed Description:
Prospective, two arms, randomized multi-center trial in Asian-pacific region. Following angiography, patients with chronic total occlusion (more than 3 months) have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) drug-eluting stent vs. b) optimal medical treatment. All patients will be followed for at least 3 year.
The subjects with chronic total occlusion but failed to random for any reason, they will be enrolled in registry group.
The random design was closed at the date of 22 July 2019 however already randomized subjects and subjects from registry design continue 10 years follow-up on IRIS-CTO registry.
The subjects with chronic total occlusion but failed to random for any reason, they will be enrolled in registry group.
The random design was closed at the date of 22 July 2019 however already randomized subjects and subjects from registry design continue 10 years follow-up on IRIS-CTO registry.
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?: