Ignite Creation Date:
2024-05-06 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03394079
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-20
First Post:
2017-12-25
Brief Title:
Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention
Sponsor:
Seung-Jung Park
Organization:
Asan Medical Center
Study Overview
Official Title:
A Prospective Open Label Multi-center Dual Arm Randomized Pragmatic Trial Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
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:
OCTIVUS
Brief Summary:
The primary aim of this study is to compare the clinical efficacy and safety of OCT-guidedoptical coherence tomography OCT-guided and IVUS-guidedIntravascular ultrasound IVUS-guided strategies in patients undergoing Percutaneous coronary intervention PCI with contemporary drug-eluting stents DES or drug-coated balloons only for in-stent restenosis for significant obstructive Coronary artery disease CAD
The investigators hypothesize that OCT-guided PCI is non-inferior to IVUS-guided PCI with respect to primary end point of target-vessel failure cardiac death target-vessel myocardial infarction MI or ischemia-driven target-vessel revascularization TVR at 1 year after randomization
The investigators hypothesize that OCT-guided PCI is non-inferior to IVUS-guided PCI with respect to primary end point of target-vessel failure cardiac death target-vessel myocardial infarction MI or ischemia-driven target-vessel revascularization TVR at 1 year after randomization
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None