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

NCT07853261 | Recruiting

• 1 other identifier: stepwise stent postdilation
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Drug Eluting Stents

Keywords

coronary artery disease; stent; post dilation; stent expansion

Outcome Measures

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.

  3 days

Study Arms (1)

Serial pressure dilation

EXPERIMENTAL

After stent nominal pressure deployment stent will be postdilated at 12atm\*10s, 18atm \*10s, 24atm\*10s.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.IVUS measurement will be done after each dilation for the MSA and stent expansion

Device: Coronary stent + non-compliant post-dilation balloon

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

Serial pressure dilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Hemodynamically unstable
• Presence of anatomical or pathological factors preventing IVUS catheter crossing.

Sponsors & Collaborators

• Jilin University: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Mingyou Zhang, M.D.

CONTACT

8613689842200; zmy@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: October 1, 2026
• Study Start: January 7, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

CN (1)