This study is designed as a prospective, multicenter, 1:1 randomized controlled trial. It plans to enroll 280 patients with moderate-to-severe calcified coronary lesions who are candidates for IVUS-guided DES implantation. Subjects will be randomized in a 1:1 ratio to the experimental group (n=140) or the control group (n=140). The primary endpoint is the MSA measured by IVUS immediately after the procedure, with the purpose of verifying the safety and efficacy of the high-pressure cutting balloon in optimizing stent implantation outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
280
Lesion preparation is carried out using the cutting balloon, and following completion of preparation, all stents are deployed at nominal pressure.
Lesion preparation is carried out using the non-cutting balloon, and following completion of preparation, all stents are deployed at nominal pressure.
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
RECRUITINGMinimum stent area (MSA) at the site of maximum calcification immediately after stent implantation
IVUS-measured results obtained after stent implantation and prior to balloon post-dilation
Time frame: procedure day (0 day)
Procedural success
Defined as successful stent implantation, residual stenosis ≤20%, absence of severe complications such as severe dissection, perforation, acute occlusion, no-reflow, and intraprocedural death, and TIMI 3 flow in the target vessel.
Time frame: procedure day (0 day)
Strategy success
Defined as successful stent implantation, residual stenosis ≤20%, absence of severe complications such as severe dissection, perforation, acute occlusion, no-reflow, and intraprocedural death, and no need for alternative calcium modification devices (e.g., bailout rotational atherectomy, excimer laser coronary atherectomy, shockwave balloon).
Time frame: procedure day (0 day)
Major adverse cardiac events (MACE)
Defined as a composite endpoint consisting of all-cause death, unplanned urgent target vessel revascularization, unplanned cardiac surgery, or spontaneous myocardial infarction.
Time frame: the hospitalization period and 30-day after procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.