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Impact of Stepwise Pressure-Increasing NC Balloon Post-Dilation on Stent Expansion

RecruitingNAAges 18 Years - anyAllJilin University
NCT07853261 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a prospective, single-center, single-arm exploratory observational study aiming to evaluate the impact of stepwise pressure-increasing non-compliant (NC) balloon post-dilation on stent expansion rate in patients undergoing single-stent implantation for coronary artery stenosis, with stent sizing guided by intravascular ultrasound-external elastic membrane (IVUS-EEM) measurement. A total of 150 eligible patients will be enrolled at The First Hospital of Jilin University. All participants will receive standard single-stent implantation followed by multi-stage stepwise pressure-increasing NC balloon post-dilation under IVUS monitoring. The post-dilation protocol includes sequential inflation at nominal pressure, rated burst pressure, and 24 atm, with IVUS assessment performed after each stage. All treatment procedures are conducted in accordance with routine clinical practice; no a

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 years regardless of gender; * Coronary angiography confirms single-vessel coronary artery stenosis ≥50%, meeting the indication for single-stent implantation; * Preoperative IVUS examination can clearly visualize the vessel EEM, allowing for stent size measurement and assessment of stent expansion-related parameters; * The patient voluntarily participates in this study and signs the informed consent form; * No contraindications related to IVUS examination, stent implantation, or balloon angioplasty. Exclusion Criteria: * Hemodynamically unstable * Presence of anatomical or pathological factors preventing IVUS catheter crossing.
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What it tests

  • Coronary stent + non-compliant post-dilation balloon
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Where

1 site
The First Hospital of Jilin University
Changchun, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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