Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-26 @ 11:32 PM
Study NCT ID:
NCT05100992
Status:
RECRUITING
Last Update Posted:
2021-10-29
First Post:
2021-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Progress Bifurcation Global Registry
Sponsor:
Minneapolis Heart Institute Foundation
Organization:
Study Overview
Official Title:
Prospective Global Registry of Percutaneous Coronary Intervention in Bifurcation Lesions (PROGRESS-BIFURCATION)
Status:
RECRUITING
Status Verified Date:
2021-10
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:
Coronary bifurcation lesions are lesions (or blockages) that occur at or near the intersection of a major coronary artery and one of the arteries' side branches.
Numerous techniques and devices have been developed to treat coronary bifurcations; however, these types of lesions remain some of the most challenging, both in terms of procedural success and outcome. This study is designed as an observational, multi-center registry that will collect information on treatment strategies and outcomes of consecutive patients undergoing percutaneous coronary interventions (PCI) in coronary bifurcations among various participating centers, in order to determine the frequency of bifurcation PCI, the procedural strategies utilized, and the procedural outcomes.
Numerous techniques and devices have been developed to treat coronary bifurcations; however, these types of lesions remain some of the most challenging, both in terms of procedural success and outcome. This study is designed as an observational, multi-center registry that will collect information on treatment strategies and outcomes of consecutive patients undergoing percutaneous coronary interventions (PCI) in coronary bifurcations among various participating centers, in order to determine the frequency of bifurcation PCI, the procedural strategies utilized, and the procedural outcomes.
Detailed Description:
Numerous techniques and devices have been developed to treat coronary bifurcations; however, these types of lesions remain some of the most challenging, both in terms of procedural success and outcome. Several techniques are currently being utilized to treat coronary bifurcation lesions, including a 1-stent provisional stenting technique. Various 2-stent techniques are also performed, including: double kiss crush (DK crush4), culotte, T and protrusion (TAP), crush, mini-crush, reverse crush and V-stenting. The optimal technique for bifurcation stenting when two stents are required remains controversial; however, the DK crush technique appears to have stronger data, especially for left main bifurcations. However, DK crush can be challenging to perform, requiring several steps and frequent troubleshooting.
The adoption of DK crush and other 2-stent bifurcation strategies, as well as the rigor of implementation, have received limited study. This study is designed as an observational, multi-center registry that will collect information on treatment strategies and outcomes of consecutive patients undergoing percutaneous coronary interventions (PCI) in coronary bifurcations among various participating centers, in order to determine the frequency of bifurcation PCI, the procedural strategies utilized,
The adoption of DK crush and other 2-stent bifurcation strategies, as well as the rigor of implementation, have received limited study. This study is designed as an observational, multi-center registry that will collect information on treatment strategies and outcomes of consecutive patients undergoing percutaneous coronary interventions (PCI) in coronary bifurcations among various participating centers, in order to determine the frequency of bifurcation PCI, the procedural strategies utilized,
Study Oversight
Has Oversight DMC:
False
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?: