An observational study in Coronary Artery Disease and Left Main Coronary Artery Disease, sponsored by Shanghai Zhongshan Hospital. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-08-28.
Sponsored by Shanghai Zhongshan Hospital · Observational
To compare the 3 - year clinical follow - up results of patients with left main bifurcation lesions treated by intravascular ultrasound(IVUS) - guided and coronary angiography(CAG) - guided percutaneous coronary intervention(PCI), and to confirm the clinical benefits of optimizing interventional therapy of left main bifurcation lesions by intravascular ultrasound(IVUS).
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 616 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.
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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)
Exclusion Criteria:
In this group, intravascular ultrasound(IVUS) in addition to coronary angiography(CAG) is used to guide percutaneous coronary intervention(PCI) procedure of left main bifurcation lesion.
Device: intravascular ultrasound (IVUS) · Other: coronary angiography
In this group, coronary angiography(CAG) is used to guide percutaneous coronary intervention(PCI) procedure of left main bifurcation lesion.
Other: coronary angiography
use IVUS in the procedure
Coronary angiography is required for all PCI procedure.
Target vessel failure rate(the rate of outcomes including cardiac death, target vessel myocardial infarction(MI), and clinically driven main branch or side branch target vessel revascularization(TVR) in each group)
Cardiac death is defined as death resulting from an acute myocardial infarction (MI), sudden cardiac death, stroke, death due to heart failure (HF), death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes; target vessel MI is defined as a MI case with the evidence of myocardial necrosis in the vascular territory of previously treated vessel; clinically driven main branch or side branch TVR is defined as a revascularization procedure with repeated stenting, balloon angioplasty or surgical bypass grafting for restenosed or occluded culprit target vessel.
Time frame: 12th month after stent implantation
major adverse cardiac and cerebrovascular events（MACCE）rate（ the percentage of outcomes including all cause death, stroke, myocardial infarction(MI), and all clinically driven target vessel revascularization(TVR) in each group)
TVR is defined as a revascularization procedure with repeated stenting, balloon angioplasty or surgical bypass grafting for restenosed or occluded culprit target vessel.
Time frame: 30 days, 6 months, 12 months, 24 months and 36 months after operation
The percentage of in-stent restenosis (ISR) assessed by quantitative coronary angiography(QCA) in each group
ISR is defined as a \>50% stenosis of a previously stented segment as judged by QCA after coronary angiography
Time frame: 12 months after operation
No study locations are listed for this record.
Plan to share: No — Whether to share the data will be decided by the principal investigator
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Shanghai Zhongshan Hospital