Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-25 @ 4:20 PM
Study NCT ID:
NCT01667757
Status:
COMPLETED
Last Update Posted:
2015-03-24
First Post:
2012-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimal Physiologic Intravascular Ultrasound Imaging Criteria After Drug Eluting Stent Implantation
Sponsor:
Inje University
Organization:
Study Overview
Official Title:
Angiographic and IVUS Criteria Defining Physiologic Optimization By the Fractional Flow Reserve After DES Implantation
Status:
COMPLETED
Status Verified Date:
2015-03
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:
None
Brief Summary:
Invasive imaging criteria of the Coronary arteriography (CAG) and intravascular ultrasound imaging (IVUS), satisfying procedural optimization after drug eluting stent (DES) implantation, were used in \< 10% DS by CAG and 5-5.5mm2 MSA by IVUS. Whether these criteria satisfy not only relieving visible stenosis but also relieving lesion specific ischemia or not were unclear. Fractional flow reserve (FFR), an index of lesion specific ischemia, was proposed 0.9 as a physiologic criteria satisfying successful stent implantation by previous studies with bare metal stent. FFR after drug-eluting stent implantation can be an useful predictor for clinical outcome. But, direct comparative evaluation of the invasive imaging criteria defining as an indicator relieving myocardial ischemia were not reported. The aim of this study was to investigate angiographic and IVUS parameters in which corresponding FFR and evaluate their optimal physiologic criteria after DES implantation.
Detailed Description:
None
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?: