High-Pressure Cutting Balloon for Calcified Coronary Artery Blockages Before Stent Placement
Compares a high-pressure cutting balloon with a non-cutting balloon in calcified coronary artery disease.
Plain-language title generated from the registry record
Registry title: Post-Marketing Clinical Study of High-Pressure Cutting Balloon
Key facts
- Where
- Xi’an, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with coronary artery disease and moderate-to-severe calcified lesions who need a drug-eluting stent placed with ultrasound (IVUS) guidance.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Moderate-to-severe calcified lesion seen on coronary angiography. It must be a new lesion in a native vessel, 2.5-4.0 mm wide, that the guidewire can cross.
- Earlier treatment
- The target lesion must not have had any earlier interventional treatment.
Main reasons for not taking part
- Life expectancy under 1 year
- Cardiogenic shock or unstable circulation
- Left main coronary artery disease or chronic total occlusion
- Active bleeding, bleeding tendency, or unable to take antiplatelet or anticoagulant drugs
- Pregnant or breastfeeding women
Read by machine on 13 November 2026.
Where in China
- The First Affiliated Hospital of Xi'an Jiaotong UniversityXi’an, ChinaContact: Ning Guo, ProfessorTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- BrosMed Medical Co., Ltd
- Trial code
- NCT07835178
- Record updated
- 22 September 2026
- Original description
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.Read full original descriptionShow less
A Clinical Study of the High-Pressure Cutting Balloon for Interventional Treatment of Calcified Coronary Lesions
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.
Inclusion: 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; Target vessel diameter of 2.5-4.0 mm, with guidewire crossing of the target lesion; In patients with multiple lesions, only one lesion will be selected as the target lesion in this study. If target and non-target lesions are treated during the same procedure, the target and non-target lesions must be located in different vessel branches; furthermore, the non-target lesion must be treated first, and the target lesion may be treated only after successful revascularization of the non-target lesion without severe angiographic complications; Provision of written informed consent.
Exclusion: Non-target vessel revascularization within 30 days before randomization with complications; Left main coronary artery disease; Active bleeding; Known history of allergy to contrast media or metals; Patients with a bleeding tendency, contraindications to antiplatelet or anticoagulant therapy, or inability to receive anticoagulation therapy; New-onset stroke/transient ischemic attack within 6 months; Left ventricular ejection fraction <25%, or NYHA functional class IV, or Killip class ≥2; Life expectancy <1 year; Cardiogenic shock or hemodynamic instability; Chronic total occlusion; Bifurcation lesions planned for a "two-stent strategy"; Pregnant or lactating women.