Heart stent study tests if extra ultrasound imaging saves lives
NCT ID NCT07512778
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two ways to guide heart stent placement in people with acute coronary syndrome (unstable angina or heart attack). One method uses standard X-ray images (angiography), and the other adds an ultrasound probe inside the artery (IVUS) for more detail. About 1,500 participants will be randomly assigned to one of the two methods. The goal is to see if IVUS reduces the chance of heart-related death, heart attack, or the need for another procedure within two years.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 1,500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2025
- Expected to finish
-
Dec 2031
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
19 to 90 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients 19 years of age or older 2. Patients with unstable angina pectoris, and acute MI including NSTEMI or STEMI. 3. Coronary artery disease defined as \>70% stenosis (reference vessel diameter 2.5 - 5.0 mm based on operator assessment) with identifiable culprit lesion indicated stent implantation 4. All lesions must be suitable for treatment with the Synergy stent system, or other Synergy platform iteration 5. The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site. Exclusion Criteria: 1. Age \>90 years 2. Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, poly(L-lactide), poly(DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoro polymers that cannot be adequately premedicated. 3. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors 4. An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs within 6 m after the procedure. 5. Cardiogenic shock 6. Restenotic lesions 7. Compromised left ventricular dysfunction (LVEF \<30%) 8. At the time of screening, the subject has a malignancy that is not in remission 9. Non-cardiac co-morbidities with a life expectancy less than 1 year 10. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. 11. Subject belongs to a vulnerable population (per investigator's judgment) or subject unable to read or write 12. Concern for inability of the patient to comply with study procedures and/or follow-up (e.g., alcohol or drug abuse) 13. Pregnancy
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute coronary syndromes (ACS) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
RECRUITINGSeoul, Eunpyeong-gu, 03312, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- The heart rhythm threat hiding in heart attack wards
- Magnetic heart signals could help ER doctors spot hidden heart risk
- Heart arteries without metal: CT scans track Drug-Coated balloon results
- Can a Drug-Coated balloon beat a stent for tough heart attacks?
- Can a Triple-Drug cholesterol blitz make heart plaques safer?
- A 15-Minute audio break: could guided imagery soothe heart patients?