Ignite Creation Date:
2024-07-17 @ 10:52 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484647
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-26
Brief Title:
Comparing T-stenting And Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation
Sponsor:
San Luigi Gonzaga Hospital
Organization:
San Luigi Gonzaga Hospital
Study Overview
Official Title:
Comparing T-stenting And Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation Insights From TREX Registry
Status:
RECRUITING
Status Verified Date:
2024-07
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:
Nowadays no studies compare the T-stenting And Minimal Protrusion TAP and External Minicrush techniques in treating complex coronary bifurcation so eventually procedural clinical and safety differences remain unknown
Detailed Description:
1 According to DEFINITION criteria PCI of the complex coronary bifurcation with up-front two stent techniques is associated with lower target vessel revascularization TVR compared to Provisional Stenting
2 The Double-Kissing Crush stenting DK-Crush has been tested with the Culotte and the Classic Crush techniques in the unprotected left main disease ULMD and in no-ULMD setting respectively showing better clinical outcomes
3 However due to its technical complexity and simultaneous improvement of the Classic Crush technique evolving in the External Minicrush it has meant that the latter has become the most used technique in the clinical practice in treating complex coronary bifurcation
4 The DK-Crush technique has never been tested with the External Minicrush leaving the operators to choose one or the other according to their experience and preferences
5 The T-stenting And Minimal Protrusion TAP is a two-stent technique described to treat coronary bifurcation after provisional treating Compared to crush techniques it does not require crushing of the side branch stent but only minimal protrusion of the side branch stent before main vessel stenting
6 Nowadays no studies compare theTAP and the External Minicrush in treating complex coronary bifurcation so eventually procedural clinical and safety differences remain unknown
7 The issues importance is highlighted by higher rates of stent thrombosis ST and in-stent restenosis ISR of the two stent techniques compared to Provisional Stenting in treating coronary bifurcation8
8 Consequently investigating the efficacy and safety differences between the techniques could improve the treatment of complex coronary bifurcation to reduce post-PCI TLR
2 The Double-Kissing Crush stenting DK-Crush has been tested with the Culotte and the Classic Crush techniques in the unprotected left main disease ULMD and in no-ULMD setting respectively showing better clinical outcomes
3 However due to its technical complexity and simultaneous improvement of the Classic Crush technique evolving in the External Minicrush it has meant that the latter has become the most used technique in the clinical practice in treating complex coronary bifurcation
4 The DK-Crush technique has never been tested with the External Minicrush leaving the operators to choose one or the other according to their experience and preferences
5 The T-stenting And Minimal Protrusion TAP is a two-stent technique described to treat coronary bifurcation after provisional treating Compared to crush techniques it does not require crushing of the side branch stent but only minimal protrusion of the side branch stent before main vessel stenting
6 Nowadays no studies compare theTAP and the External Minicrush in treating complex coronary bifurcation so eventually procedural clinical and safety differences remain unknown
7 The issues importance is highlighted by higher rates of stent thrombosis ST and in-stent restenosis ISR of the two stent techniques compared to Provisional Stenting in treating coronary bifurcation8
8 Consequently investigating the efficacy and safety differences between the techniques could improve the treatment of complex coronary bifurcation to reduce post-PCI TLR
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