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Recruiting Not applicable

Post-Marketing Clinical Study of High-Pressure Cutting Balloon

NCT07835178 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-09
Last updated
2026-09-22

Condition(s) studied

Coronary Artery DiseaseCalcification

Investigational drug(s) / intervention(s)

High pressure cutting balloonNon-cutting balloon

High pressure cutting balloon: Lesion preparation is carried out using the cutting balloon, and following completion of preparation, all stents are deployed at nominal pressure.

Non-cutting balloon: Lesion preparation is carried out using the non-cutting balloon, and following completion of preparation, all stents are deployed at nominal pressure.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * Life expectancy \<1 year; * Cardiogenic shock or hemodynamic instability; * Left main coronary artery disease; * Chronic total occlusion; * Bifurcation lesions planned for a "two-stent strategy"; * 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; * Pregnant or lactating women; * Left ventricular ejection fraction \<25%, or NYHA functional class IV, or Killip class ≥2; * Non-target vessel revascularization within 30 days before randomization with complications.

Primary outcome measure(s)

  • Minimum stent area (MSA) at the site of maximum calcification immediately after stent implantation — procedure day (0 day)
    IVUS-measured results obtained after stent implantation and prior to balloon post-dilation

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07835178 on ClinicalTrials.gov ↗ ← All trials in China