A number of 1448 patients scheduled for elective percutaneous coronary intervention (PCI) with a native coronary stenosis suitable for DES implantation and IVUS imaging are openly randomized 1:1 to either IVUS guidance or angiographic guidance groups.
The study is prospectively conducted at 8 high-volume PCI centers in China with IVUS expertise. Clinic follow-up are planned in all patients 12 months after implantation of drug eluting stents. Primary endpoint is target vessel failure. The study is powered for primary endpoint, which are likely to reach significance at the level P \< 0.05 even at a follow-up drop-out rate up to 10%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,448
The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. Additional stent implantation or post dilation will be allowed according to attending physician's discrete. IVUS will be not used in this arm.
The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. IVUS will be used to assess the anatomic characteristics of lesion and determine appropriate stent size and length. Additional stent implantation or post dilation will be allowed according to attending physician's discrete based on IVUS results.
Nanjing First Hospital
Nanjing, Jiangsu, China
Target Vessel Failure
The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization.
Time frame: 12 months
Mortality
the occurrence of 1-year all cause death
Time frame: 12 months
Cardiac death
Death that could not be attributed to a noncardiac etiology was considered cardiac death.
Time frame: 12 months
Myocardial infarction
Myocardial infarction was diagnosed by electrocardiographic changes and/or a rise and fall of creatine kinase-myocardial band fraction in the presence of ischemic symptoms.
Time frame: 12 months
Target vessel revascularization
Target vessel revascularization was defined as repeated revascularization by PCI or surgery of the target vessel.
Time frame: 12 months
Target lesion revascularization
Target lesion revascularization was defined as any revascularization procedure performed at the site of the treated lesion associated with clinical and/or objective evidence of inducible myocardial ischemia.
Time frame: 12 months
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