Stepwise Pressure-Adjusted Balloon Post-Dilation After a Single Stent

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, single-arm exploratory study enrolling 150 adults with single-vessel coronary artery stenosis indicated for a single stent. After standard stent implantation, patients undergo multi-stage post-dilation using an non-compliant balloon at sequential pressures (nominal, rated burst, and 24 atm) with IVUS checks after each stage to assess expansion. Stent sizing is guided by IVUS-external elastic membrane measurements to optimize fit. No randomization or additional interventions beyond standard care are performed. The trial seeks to characterize how stepwise pressure increases influence stent expansion and immediate post-procedural apposition.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Hospital of Jilin University
  Changchun, Jilin, China Recruiting

Study contacts

• Study coordinator: Mingyou Zhang, M.D.
• Email: zmy@jlu.edu.cn
• Phone: 8613689842200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.