Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
NCT Number: NCT02215915
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Nanjing, Jiangsu, 210006, China
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%.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Intravascular ultrasound
Other names: Percutaneous coronary drug-eluting stents implantation
Time frame: 12 months
The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization.
Time frame: 12 months
the occurrence of 1-year all cause death
Time frame: 12 months
Death that could not be attributed to a noncardiac etiology was considered cardiac death.
Time frame: 12 months
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 was defined as repeated revascularization by PCI or surgery of the target vessel.
Time frame: 12 months
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
Stent thrombus was classified as definite, probable, or possible, according to the definitions provided by the Academic Research Consortium (ARC).Regarding timing, ST was defined as early (<30 days), late (30 days to 1 year), or too late (>1 year).
Nanjing First Hospital, Nanjing Medical University
Other
Acronym: ULTIMATE
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