Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-12 @ 12:33 PM
Study NCT ID:
NCT00694005
Status:
COMPLETED
Last Update Posted:
2015-11-20
First Post:
2008-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Choice Of Optimal Strategy For Bifurcation Lesions With Normal Side Branch
Sponsor:
Seung-Jung Park
Organization:
Study Overview
Official Title:
Phase IV Study of the Choice of Optimal Strategy for Bifurcation Lesions With Normal Side Branch
Status:
COMPLETED
Status Verified Date:
2015-11
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:
CROSS
Brief Summary:
Few data are available about the late patency of side branches in association with the currently used stent types and implantation techniques.
Detailed Description:
Among the bifurcation type, bifurcation lesion without significant side branch stenosis (\<50%) usually did not require side branch stenting, but owing to several putative mechanism including dissection, thrombosis formation, embolization of plaque debris, ostial compromise by displaced stent strut, and snow plow effect, the side branch might be compromised. In this situation, the strategy to achieve optimal results has not been reported. Recently, FFR study showed that most jailed side branch (vessel size \>2.0 mm. DS\>50%) after main branch stenting did not have functional significance. We compared strategies with or without routine kissing balloon dilatation for less than 50% stenosis after simple DES crossing for bifurcation lesions (bifurcation type 1.1.0, 1.0.0, and 0.1.0 according to Medina classification) with serial change of FFR measurement.
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?: