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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Jilin University • ClinicalTrials.gov ID: NCT07853261

Registry updated: 2026-10-01
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Description

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 additional randomization or mandatory intervention is applied beyond the standard of care. The study solely observes and records outcomes associated with this treatment strategy.

Interventions

  • Coronary stent + non-compliant post-dilation balloon (Device)
    Coronary stent implantation followed by serial pressure post-dilation using non-compliant balloon under IVUS guidance

Eligibility criteria

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.

Conditions

Coronary Artery Disease Drug Eluting Stents

Locations

  • The First Hospital of Jilin University — Changchun, Jilin, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record