Progress Bifurcation Global Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMinneapolis Heart Institute Foundation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Over 18 years of age
undergoing bifurcation percutaneous coronary intervention
Disqualifiers
None
Trial population
Subjects over 18 years of age and undergoing bifurcation percutaneous coronary intervention at each of the participating center.
Trial design
Design model
Case-only
Time perspective
Other
Treatments tested in this trial
Percutaneous Coronary Interbention
Procedure/SurgeryPercutaneous Coronary Interbention
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Procedural Success During Bifurcation PCI
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.Secondary outcomes
1
Technical Success
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.
Time frame
From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov