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

Condition(s) studied

Investigational drug(s) / intervention(s)

Coronary stent + non-compliant post-dilation balloon: Coronary stent implantation followed by serial pressure post-dilation using non-compliant balloon under IVUS guidance

Study summary

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.

Eligibility

Primary outcome measure(s)

• Minimum Stent Area (MSA) — 3 days
  IVUS-measured minimum lumen cross-sectional area within the stented segment post-procedure (after stent deployment with norminal pressure, 12\*10 atm, 18\*10 atm and 24\*10 atm NC balloon post-dilation), Final post-dilation will be attempted at 24 atm for up to 120 seconds, with the duration limited to the patient's maximum tolerated time if premature intolerance occurs.

Trial sites (1)

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