Impact of Stepwise Pressure-Increasing NC Balloon Post-Dilation on Stent Expansion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJilin University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Hemodynamically unstable
Presence of anatomical or pathological factors preventing IVUS catheter crossing.
Trial design
Design model
Single group
Treatments tested in this trial
Coronary stent + non-compliant post-dilation balloon
DeviceCoronary stent implantation followed by serial pressure post-dilation using non-compliant balloon under IVUS guidance
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Serial pressure dilationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Minimum Stent Area (MSA)
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.
Time frame
3 daysSponsors and contacts
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Source ClinicalTrials.gov