Post-Marketing Clinical Study of High-Pressure Cutting Balloon
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrosMed Medical Co., Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years;
Patients with coronary artery disease who indicate IVUS-guided drug-eluting stent implantation;
Moderate-to-severe calcified lesions on coronary angiography;
Target lesion is a de novo lesion in a native vessel that has not received any prior interventional treatment;
Disqualifiers
Life expectancy <1 year;
Cardiogenic shock or hemodynamic instability;
Left main coronary artery disease;
Chronic total occlusion;
Trial design
Design model
Parallel
Treatments tested in this trial
High pressure cutting balloon
DeviceLesion preparation is carried out using the cutting balloon, and following completion of preparation, all stents are deployed at nominal pressure.
Non-cutting balloon
DeviceLesion preparation is carried out using the non-cutting balloon, and following completion of preparation, all stents are deployed at nominal pressure.
Treatment groups
280 Participants
are divided into 2 treatment groupsGroup A: Test groupExperimental treatment 1 intervention
Group B: Control groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Minimum 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)Secondary outcomes
1
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)2
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)3
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 procedureSponsors and contacts
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Source ClinicalTrials.gov