Drug-coated balloon (DCB) is an alternative choice for denovo lesions in coronary artery disease patients with high bleeding risk. Intravascular ultrasound (IVUS) can provide more details of coronary anatomy and stent implantation, overcoming a number of limitations of coronary angiography. However, the benefit of IVUS-guided DCB treatment has not been investigated. This study is designed to compare IVUS-guided and Angiography-guided DCB treatment for coronary denovo lesions in patients with high bleeding risk.
This is a prospective, multicenter, randomized controlled trial that aims to enroll 260 patients with high bleeding risk. All patients with coronary denovo lesions suitable for DCB treatment will undergo 1:1 randomization to either IVUS guidance or Angiography guidance using the Central Randomization System. All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol. Data and images will be collected during the index procedure, and at the predefined 7-month coronary angiography follow-up visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
260
IVUS (Boston Scientific®) guidance + DCB (Sequent® Please) treatment
DCB (Sequent® Please) treatment
Nanjing First Hospital
Nanjing, Jiangsu, China
late lumen loss (LLL) at 7 months after procedure
LLL is defined as the difference between postprocedural minimal lumen diameter (MLD) minus MLD at the time of angiographic follow-up
Time frame: 7 months
Target vessel failure (TVF) at 6 months
TVF is defined as the composite of cardiac death, target-vessel myocardial infarction and ischemia-driven target-vessel revascularization.
Time frame: 6 months
bleeding at 6 months
bleeding
Time frame: 6 months
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