STEMIINSIGHT-STEMINCT07616024
Intravascular Ultrasound guidaNce versuS angIoGrapHy Guidance in Patients With ST-segment Elevation Myocardial Infarction
A study testing Intravascular Ultrasound and Coronary angiography guidance in people with STEMI and PCI, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
STEMI represents the subtype of ACS with the worst prognosis, associated with high mortality and an elevated risk of complications. The use of IVI guidance holds the potential to reduce the incidence of MACE. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Intravascular Ultrasound and Coronary angiography guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,488 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 Dec 2032
- 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
- Patients diagnosed with acute ST-segment elevation myocardial infarction (STEMI) who have an indication for emergency interventional therapy;
- Subjects who are eligible to undergo primary percutaneous coronary intervention (PCI);
- Subjects or their authorized family members voluntarily agree to participate in the clinical trial and sign the written informed consent form;
- The IVUS catheter is expected to pass through the target lesion to complete the examination.
Who cannot join
- Patients with cardiogenic shock or severe heart failure (Killip class IV);
- Patients who have previously undergone coronary artery bypass grafting (CABG);
- Patients with coma or disturbance of consciousness;
- Patients who are expected to be intolerant to long-term antiplatelet therapy;
- Pregnant women;
- Life expectancy < 1 year;
- Currently participating in another drug/device clinical trial and not having reached the primary endpoint;
- Poor compliance, expected to be unable to complete follow-up.
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
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Chenguang Li, Doctor, +8613816767665, li.chenguang@zs-hospital.sh.cn
Junbo Ge, Doctor
About this study
Official title: Intravascular Ultrasound guidaNce versuS angIoGrapHy Guidance in Primary percuTaneous Coronary Intervention for Patients With ST-segment Elevation Myocardial Infarction
STEMI represents the subtype of ACS with the worst prognosis, associated with high mortality and an elevated risk of complications. The use of IVI guidance holds the potential to reduce the incidence of MACE. In previous studies, there has been limited research on intravascular imaging in the context of primary revascularization procedures for STEMI, and no large-scale cohort study has compared the differences in clinical outcomes between IVI-guided and angiography-guided primary revascularization. Therefore, we conducted this large-scale randomized controlled trial to compare IVI-guided primary PCI versus coronary angiography-guided primary PCI in patients with STEMI.
Read the detailed description
This study is a prospective, multicenter, randomized controlled, superiority clinical trial. Eligible subjects who meet the inclusion/exclusion criteria will be randomly assigned in a 1:1 ratio to either the IVUS-guided strategy (experimental group) or the conventional coronary angiography-guided strategy (control group). The study plans to enroll at least 2488 subjects, with 1244 subjects in each of the experimental and control groups. Zhongshan Hospital, Fudan University serves as the lead center. A competitive enrollment approach will be adopted, with the number of cases enrolled by the lead center not exceeding 50% of the total sample size.
In the IVUS group, intravascular ultrasound (IVUS) will be used for guidance; the use of high-frequency intravascular ultrasound (resolution ≥ 50 MHz) is encouraged, though not mandatory.
- Being tested
- Intravascular Ultrasound, Coronary angiography guidance
- Keywords
- STEMI, PCI, IVUS
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular UltrasoundProcedure or surgery
Also called IVUS group
a catheter equipped with an ultrasound transducer is advanced over a guidewire into the vessel lumen distal to the target coronary lesion. Then, while slowly withdrawing the catheter, 360-degree cross-sectional images of the vessel are acquired to accurately measure lumen dimensions, assess plaque characteristics, select an appropriately sized stent, and confirm that after stent implantation the stent is fully apposed, well expanded, and free of vascular complications.
Coronary angiography guidanceProcedure or surgery
Also called CAG group
A catheter is inserted through a peripheral artery (e.g., femoral or radial artery) and advanced to the ostium of the coronary arteries under fluoroscopic guidance. Once positioned, contrast medium is injected while X-ray images are acquired to visualize the coronary artery lumen and detect any stenoses or occlusions.
| Study group | Role | What they receive |
|---|---|---|
| IVUS group | Experimental | In the experimental group, after the guidewire passes through the lesion, IVUS is used to guide the primary PCI procedure. Receives: Procedure: Intravascular Ultrasound |
| CAG group | Other | In the control group, after the guidewire passes through the lesion, coronary angiography is used to guide the primary PCI procedure Receives: Procedure: Coronary angiography guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary target vessel failure (TVF) rate
defined as the composite endpoint of cardiac death, ischemia-driven target vessel revascularization, and target vessel-related myocardial infarction.
Measured: 1 year
Secondary outcomes (6)
Lesion success rate
Lesion success assessed by coronary angiography and lesion success rate assessed by IVUS.
Measured: Perioperative
Clinical success rate
Lesion success assessed by coronary angiography and lesion success rate assessed by IVUS.
Measured: Pre-discharge
Mortality rate
Includes cardiovascular death, non-cardiovascular death, and death of undetermined cause
Measured: 1 Year
Incidence of myocardial infarction
includes periprocedural myocardial infarction as defined by SCAI and spontaneous myocardial infarction (infarct-related artery-related vs. non-infarct-related artery-related; culprit lesion-related vs. non-culprit lesion-related)
Measured: 1 year
Revascularization
includes ischemia-driven and non-ischemia-driven revascularization, revascularization of infarct-related and non-infarct-related arteries, revascularization of culprit and non-culprit lesions, revascularization of target vessels and non-target vessels, and revascularization of target lesions and non-target lesions
Measured: 1 year
Stent thrombosis
Academic Research Consortium
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,488 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 10th People's Hospital
- Responsible party
- Sponsor
- Investigators
- Junbo Ge, Doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616024
- Sponsor's protocol ID
- B2025-555
- Other IDs
- ChiCTR2600124260
- Acronym
- INSIGHT-STEMI
- Status last verified
- Jun 2026
- First submitted
- 18 May 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Ultrasound guidaNce versuS angIoGrapHy Guidance in Primary percuTaneous Coronary Intervention for Patients With ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT07616024
- Acronym / sponsor ID
- INSIGHT-STEMI / B2025-555
- Keywords
- STEMI, PCI, IVUS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,488 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Shanghai 10th People's Hospital
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 29 May 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.
STEMI represents the subtype of ACS with the worst prognosis, associated with high mortality and an elevated risk of complications. The use of IVI guidance holds the potential to reduce the incidence of MACE. In previous studies, there has been limited research on intravascular imaging in the context of primary revascularization procedures for STEMI, and no large-scale cohort study has compared the differences in clinical outcomes between IVI-guided and angiography-guided primary revascularization. Therefore, we conducted this large-scale randomized controlled trial to compare IVI-guided primary PCI versus coronary angiography-guided primary PCI in patients with STEMI.
Detailed description
This study is a prospective, multicenter, randomized controlled, superiority clinical trial. Eligible subjects who meet the inclusion/exclusion criteria will be randomly assigned in a 1:1 ratio to either the IVUS-guided strategy (experimental group) or the conventional coronary angiography-guided strategy (control group). The study plans to enroll at least 2488 subjects, with 1244 subjects in each of the experimental and control groups. Zhongshan Hospital, Fudan University serves as the lead center. A competitive enrollment approach will be adopted, with the number of cases enrolled by the lead center not exceeding 50% of the total sample size.
In the IVUS group, intravascular ultrasound (IVUS) will be used for guidance; the use of high-frequency intravascular ultrasound (resolution ≥ 50 MHz) is encouraged, though not mandatory.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVUS group | Experimental | Procedure: Intravascular UltrasoundIn the experimental group, after the guidewire passes through the lesion, IVUS is used to guide the primary PCI procedure. |
| CAG group | Other | Procedure: Coronary angiography guidanceIn the control group, after the guidewire passes through the lesion, coronary angiography is used to guide the primary PCI procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with acute ST-segment elevation myocardial infarction (STEMI) who have an indication for emergency interventional therapy;
- Subjects who are eligible to undergo primary percutaneous coronary intervention (PCI);
- Subjects or their authorized family members voluntarily agree to participate in the clinical trial and sign the written informed consent form;
- The IVUS catheter is expected to pass through the target lesion to complete the examination.
Key exclusion criteria (8 listed)
- Patients with cardiogenic shock or severe heart failure (Killip class IV);
- Patients who have previously undergone coronary artery bypass grafting (CABG);
- Patients with coma or disturbance of consciousness;
- Patients who are expected to be intolerant to long-term antiplatelet therapy;
- Pregnant women;
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 |
|---|---|---|
| Intravascular UltrasoundAlso: IVUS groupa catheter equipped with an ultrasound transducer is advanced over a guidewire into the vessel lumen distal to the target coronary lesion. Then, while slowly withdrawing the catheter, 360-degree cross-sectional images of the vessel are acquired to accurately measure lumen dimensions, assess plaque characteristics, select an appropriately sized stent, and confirm that after stent implantation the stent is fully apposed, well expanded, and free of vascular complications. | Procedure or surgery | IVUS group |
| Coronary angiography guidanceAlso: CAG groupA catheter is inserted through a peripheral artery (e.g., femoral or radial artery) and advanced to the ostium of the coronary arteries under fluoroscopic guidance. Once positioned, contrast medium is injected while X-ray images are acquired to visualize the coronary artery lumen and detect any stenoses or occlusions. | Procedure or surgery | CAG group |
Primary outcome
Primary target vessel failure (TVF) rate
Time frame: 1 year
defined as the composite endpoint of cardiac death, ischemia-driven target vessel revascularization, and target vessel-related myocardial infarction.
6 secondary outcomes
Lesion success rate
Time frame: Perioperative
Clinical success rate
Time frame: Pre-discharge
Mortality rate
Time frame: 1 Year
Incidence of myocardial infarction
Time frame: 1 year
Revascularization
Time frame: 1 year
Stent thrombosis
Time frame: 1 year
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 18 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Junbo Ge, Doctor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravascular Ultrasound and Coronary angiography guidance in people with STEMI and PCI, run by Shanghai Zhongshan Hospital 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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 18 Jun 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 Chenguang Li, Doctor (+8613816767665, li.chenguang@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary target vessel failure (TVF) rate (time frame: 1 year). 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 18 Jun 2026.