InfiniteIntravascular Ultrasound(IVUS) vs Angiography Guided Percutaneous Coronary Intervention(PCI) for Patients With Left Main Bifurcation Lesion
Data Collection
Collected from today forward - ProspectiveArterial Occlusive Diseases+5
+ Arteriosclerosis
+ Cardiovascular Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: September 1, 2019
Actual date on which the first participant was enrolled.616 patients with primary left main coronary artery bifurcation lesions will be recruited in this study. The target lesions of patients need to be true coronary artery bifurcation lesions (Medina 1,1,1 or 0,1,1). After angiography, patients will be randomly assigned to intravascular ultrasound(IVUS) - guided and coronary angiography (CAG)- guided groups. The random number of patients will be generated by the central computer random system, and the random will be stratified according to the study sites. In coronary angiography(CAG)-guided group, two-stent technique will be used(the exact two-stent technique used was left to the operator's discretion). In intravascular ultrasound(IVUS)-guided group, minimal lumen area(MLA) in ostium of side branch will be measured by intravascular ultrasound(IVUS). If minimal lumen area(MLA)<4mm2, two-stent technique will be used(the exact two-stent technique used was left to the operator's discretion) and intravascular ultrasound(IVUS) will be repeated at the end of the procedure. If minimal lumen area(MLA) >=4mm2, one-stent technique will be used and intravascular ultrasound(IVUS) will be repeated. If minimal lumen area(MLA) in ostium of side branch is still >=4mm2, the procedure will be ended. If minimal lumen area(MLA) in ostium of side branch become <4mm2, the following interventional strategy will be left to the operator's discretion( balloon inflation, drug-eluting balloon, or switch to two-stent technique). Again, intravascular ultrasound(IVUS) will be repeated at the end of the procedure.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.616 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives