Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546748
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Mini Crush or Double Kissing Crush Stenting Techniques For Complex Left Main Bifurcation Lesions
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Mini Crush or Double Kissing Crush Stenting Techniques For Complex Left Main Bifurcation Lesions The EVOLUTE-CRUSH Left Main Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Crush technique has evolved significantly since its introduction to the literature by Colombo et al in 2003 with multiple iterations including mini-crush MC and double kissing-crush DKC stenting techniques The main principle of crush techniques for complex bifurcation lesions is to protrude the side branch SB stent towards the main branch to adequately cover the SB ostium and minimize the risk of SB ostium restenosis It was noticed that the 4-5 mm protrusion of the SB stent resulted in a large volume of the crushed stent and the technique was modified into MC which aimed for approximately 1-2 mm protrusion by Galassi et al in 2007 Despite all the disadvantages of the crush technique the final kissing balloon inflation KBI rate of this technique along with several iterations has been up to 98 Moreover a recent meta-analysis showed that MC was associated with a reduction in risk of major cardiovascular events compared to provisional stenting crush and culotte techniques The DKC is a planned 2-stent technique introduced by Chen et al The ultimate innovation of this approach is that it is designed to increase the success rate of the final KBI Provided recrossing of the crushed stent occurs through the proximal cell another advantage of the DKC technique is to improve the success of KBI The DKC significantly reduced major cardiovascular events MACE compared to provisional stenting crush TAP and culotte Until now no clinical investigation has compared the DKC and MC in patients with complex left main bifurcation lesions Therefore this study sought to determine the clinical results of DKC and MC stenting techniques under long-term follow-up
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None