Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
Location status: Recruiting
NCT Number: NCT05100992
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Minneapolis, Minnesota, 55407, United States
Location status: Recruiting
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,
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Percutaneous Coronary Interbention
Time frame: From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure.
procedural success is defined as the absence of in-hospital major cardiac adverse events (MACE), including any of the following adverse events prior to hospital discharge: death, stroke, myocardial infarction, recurrent angina requiring urgent repeat target vessel revascularization with PCI or coronary bypass surgery, and tamponade requiring pericardiocentesis or surgery.
Time frame: From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure.
Technical success will be defined as successful bifurcation lesion recanalization by any method with achievement of < 30% residual stenosis and TIMI 3 flow in both the main vessel and side branch.
Contact information is provided by the study sponsor or research team.
Bavana Rangan, BDS, MPH
CONTACT
Emmanouil Brilakis, MD, PhD
CONTACT
Minneapolis Heart Institute Foundation
Other
Prospective Global Registry of Percutaneous Coronary Intervention in Bifurcation Lesions (PROGRESS-BIFURCATION)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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