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RECRUITING
NCT07853261
NA

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

Sponsor: Jilin University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-01-07

Completion Date

2026-12-30

Last Updated

2026-10-01

Healthy Volunteers

No

Interventions

DEVICE

Coronary stent + non-compliant post-dilation balloon

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

Locations (1)

The First Hospital of Jilin University

Changchun, Jilin, China