Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05705362
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-01-30
First Post:
2022-12-19
Brief Title:
Simple Crossover Versus Side Branch Opening in Patients With Non-Left Main Bifurcation Lesion
Sponsor:
Keimyung University Dongsan Medical Center
Organization:
Keimyung University Dongsan Medical Center
Study Overview
Official Title:
Randomized Controlled Trial of Simple CROSSsover Versus Side Branch Opening on Clinical Outcomes in Patients With Non-Left Main BIfurcation LeSion CROSS-COBIS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
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-COBIS
Brief Summary:
Hypothesis
Simple crossover strategy would be non-inferior to SB opening strategy in the risk of target lesion failure TLF in patients with angiographically compromised SB visually SB stenosis 50 after provisional MV stenting for non-left main bifurcation lesion
A total of 1000 patients 500 per each group with the angiographically compromised SB visually SB stenosis 50 after provisional MV stenting for non-left main bifurcation lesion will be enrolled Patients will be randomized to either the simple crossover strategy group or SB opening strategy group at the time of enrollment with 11 ratio Stratified randomization according to participating center clinical presentation acute coronary syndrome or stable ischemic heart disease and type of bifurcation lesions true or non-true will be performed
Simple crossover strategy would be non-inferior to SB opening strategy in the risk of target lesion failure TLF in patients with angiographically compromised SB visually SB stenosis 50 after provisional MV stenting for non-left main bifurcation lesion
A total of 1000 patients 500 per each group with the angiographically compromised SB visually SB stenosis 50 after provisional MV stenting for non-left main bifurcation lesion will be enrolled Patients will be randomized to either the simple crossover strategy group or SB opening strategy group at the time of enrollment with 11 ratio Stratified randomization according to participating center clinical presentation acute coronary syndrome or stable ischemic heart disease and type of bifurcation lesions true or non-true will be performed
Detailed Description:
Despite advances in stenting techniques and devices percutaneous coronary intervention PCI for bifurcation lesions remains one of the most challenging and complex procedures Current guidelines recommend 1-stenting with provisional side branch SB approach should be an initial treatment strategy for the bifurcation lesions based on the previous results of several randomized trials However the standardization of the provisional strategy is limited In particular there is a recommendation on the treatment technique for SB when SB intervention is required but It has not been decided in which cases SB treatment is necessary in the latest European Bifurcation Club EBC consensus document16 In previous studies the criteria for performing SB opening after MV stent intervention in the 1-stenting with provisional SB approach were varied In the DK-CUSH II Double Kissing Crush versus Provisional Stenting Technique for Treatment of Coronary Bifurcation Lesions or CACTUS Coronary Bifurcations Application of the Crushing Technique Using Sirolimus-Eluting Stents trials SB intervention was performed when the SB diameter stenosis more than 50 grade B or higher dissection or blood flow disturbance TIMI flow 2 or less after MV stent insertion On the other hand in the Nordic trial the authors applied strict criteria for SB intervention after MV stent insertion TIMI flow 2 or less only Furthermore there have been conflicting results regarding the clinical and angiographic outcomes of the jailed SB opening strategy after the main vessel MV stenting compared with the simple crossover strategy for non-left main bifurcation lesion
On this background this trial aims to compare the clinical outcomes between simple crossover and side branch opening strategies in patients with the angiographically compromised SB visually SB stenosis 50 after provisional MV stenting for non-left main bifurcation lesion
On this background this trial aims to compare the clinical outcomes between simple crossover and side branch opening strategies in patients with the angiographically compromised SB visually SB stenosis 50 after provisional MV stenting for non-left main bifurcation lesion
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