Coronary Artery DiseaseSPNDNCT07853261
Impact of Stepwise Pressure-Increasing NC Balloon Post-Dilation on Stent Expansion
A study testing Coronary stent + non-compliant post-dilation balloon in people with Coronary Artery Disease and Drug Eluting Stents, run by Jilin University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Drug Eluting Stents
- What is being tested?
- Coronary stent + non-compliant post-dilation balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Hemodynamically unstable
- Presence of anatomical or pathological factors preventing IVUS catheter crossing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130000
About this study
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.
Read the detailed description
Coronary atherosclerotic heart disease remains one of the leading causes of mortality and disability worldwide. Coronary stent implantation is a principal therapeutic strategy for coronary artery stenosis. The adequacy of stent expansion is a critical determinant of treatment efficacy; inadequate stent expansion may lead to stent malapposition, in-stent restenosis, stent thrombosis, and other adverse events that significantly compromise patient prognosis.
Intravascular ultrasound (IVUS), as an invasive vascular imaging modality, enables clear visualization of vessel wall architecture, plaque characteristics, and immediate post-stent implantation outcomes. Among its measurements, the external elastic membrane (EEM) cross-sectional area serves as a key reference for stent sizing, effectively overcoming the inherent limitation of conventional coronary angiography, which relies solely on luminal imaging for stent diameter selection.
Non-compliant (NC) balloon post-dilation is an essential step in optimizing stent implantation outcomes. Gradual incremental increases in balloon pressure may further promote adequate stent expansion and improve stent-vessel wall apposition. However, the specific impact of NC balloon post-dilation at different pressures and durations on stent expansion rate has not been systematically validated. To date, there remains a paucity of dedicated studies investigating the dynamic changes in stent expansion rate under a stepwise pressure-increasing protocol.
This study utilizes IVUS-EEM measurements to guide stent sizing and adopts a single-stent implantation strategy combined with multi-stage stepwise pressure-increasing NC balloon post-dilation. after stent deployment with norminal pressure, 12*10 atm, 18*10 atm and 24*10 atm NC balloon post-dilation. IVUS measurement will be made after each step and stent expansion and Minimal stent area will be documented.
Primary Endpoint. 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)
Secondary endpoints:
Stent Expansion Rate
IVUS-measured stent expansion rate immediately post-procedure (after stent deployment with norminal pressure, 12*10 atm, 18*10 atm and 24*10 atm NC balloon post-dilation), calculated as: (minimum stent cross-sectional area [MSA] measured by IVUS / manufacturer's nominal MSA) × 100%.
rates of stent edge dissection, hematoma, perforation.
- Conditions
- Coronary Artery Disease, Drug Eluting Stents
- Being tested
- Coronary stent + non-compliant post-dilation balloon
- Keywords
- coronary artery disease, stent, post dilation, stent expansion
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary stent + non-compliant post-dilation balloonDevice
Coronary stent implantation followed by serial pressure post-dilation using non-compliant balloon under IVUS guidance
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Coronary stent + non-compliant post-dilation balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start7 Jan 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingyou Zhang, Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853261
- Sponsor's protocol ID
- stepwise stent postdilation
- Acronym
- SPND
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Stepwise Pressure-Increasing NC Balloon Post-Dilation on Stent Expansion
- ClinicalTrials.gov ID
- NCT07853261
- Acronym / sponsor ID
- SPND / stepwise stent postdilation
- Conditions
- Coronary Artery Disease, Drug Eluting Stents
- Keywords
- coronary artery disease, stent, post dilation, stent expansion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Jilin UniversityUniversity, hospital or other
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Coronary atherosclerotic heart disease remains one of the leading causes of mortality and disability worldwide. Coronary stent implantation is a principal therapeutic strategy for coronary artery stenosis. The adequacy of stent expansion is a critical determinant of treatment efficacy; inadequate stent expansion may lead to stent malapposition, in-stent restenosis, stent thrombosis, and other adverse events that significantly compromise patient prognosis.
Intravascular ultrasound (IVUS), as an invasive vascular imaging modality, enables clear visualization of vessel wall architecture, plaque characteristics, and immediate post-stent implantation outcomes. Among its measurements, the external elastic membrane (EEM) cross-sectional area serves as a key reference for stent sizing, effectively overcoming the inherent limitation of conventional coronary angiography, which relies solely on luminal imaging for stent diameter selection.
Non-compliant (NC) balloon post-dilation is an essential step in optimizing stent implantation outcomes. Gradual incremental increases in balloon pressure may further promote adequate stent expansion and improve stent-vessel wall apposition. However, the specific impact of NC balloon post-dilation at different pressures and durations on stent expansion rate has not been systematically validated. To date, there remains a paucity of dedicated studies investigating the dynamic changes in stent expansion rate under a stepwise pressure-increasing protocol.
This study utilizes IVUS-EEM measurements to guide stent sizing and adopts a single-stent implantation strategy combined with multi-stage stepwise pressure-increasing NC balloon post-dilation. after stent deployment with norminal pressure, 12*10 atm, 18*10 atm and 24*10 atm NC balloon post-dilation. IVUS measurement will be made after each step and stent expansion and Minimal stent area will be documented.
Primary Endpoint. 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)
Secondary endpoints:
Stent Expansion Rate
IVUS-measured stent expansion rate immediately post-procedure (after stent deployment with norminal pressure, 12*10 atm, 18*10 atm and 24*10 atm NC balloon post-dilation), calculated as: (minimum stent cross-sectional area [MSA] measured by IVUS / manufacturer's nominal MSA) × 100%.
rates of stent edge dissection, hematoma, perforation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serial pressure dilation | Experimental | Device: Coronary stent + non-compliant post-dilation balloonAfter 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Hemodynamically unstable
- Presence of anatomical or pathological factors preventing IVUS catheter crossing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary stent + non-compliant post-dilation balloonCoronary stent implantation followed by serial pressure post-dilation using non-compliant balloon under IVUS guidance | Device | Serial pressure dilation |
Primary outcome
Minimum Stent Area (MSA)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary stent + non-compliant post-dilation balloon in people with Coronary Artery Disease and Drug Eluting Stents, run by Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingyou Zhang, M.D. (8613689842200, zmy@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum Stent Area (MSA) (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.