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Ultrasound-Guided stenting may cut heart risks in complex cases

NCT ID NCT03770650

Disease control Sponsor: Nanjing First Hospital, Nanjing Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether using intravascular ultrasound (IVUS) to guide a specific stenting technique (DK crush) leads to fewer heart problems than standard angiography guidance. About 556 adults with complex coronary bifurcation lesions will be randomly assigned to one of the two approaches. The main goal is to see if IVUS reduces the combined risk of cardiac death, heart attack, or need for repeat artery-opening procedures within 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
drug-eluting stent (SYNERGY)
What this could lead to
If successful, this could show that using IVUS guidance during stenting reduces the risk of heart attack, repeat procedures, or cardiac death in people with complex coronary blockages.
What could go wrong
This is a mid-stage trial with 556 participants, so results may not apply to all patients. The benefit of IVUS over standard angiography may be small, and there are always risks like stent clotting or vessel injury.

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

556 people

The number who actually took part.

Started

Dec 2018

Expected to finish

Dec 2027

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

18 years and older

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures; 2. Men and women 18 years and older; 3. Established indication for PCI according to the guidelines of ACC/AHA; 4. Native coronary lesion suitable for drug-eluting stent placement; 5. True bifurcation lesions (Medina 0,1,1/1,1,1), lesions length≤ 68 mm 6. Reference vessel diameter in side branch \> 2.5mm by visual estimation; 7. Complex bifurcation lesions based on the DEFINITION study. Exclusion Criteria: 1. Pregnancy and breast feeding mother; 2. Co-morbidity with an estimated life expectancy of \< 50 % at 12 months; 3. Scheduled surgery interrupting antiplatelet medications in the next 6 months; 4. Intolerable to DAPT; 5. Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk; 6. Unable to provide written informed consent, or fail to follow the protocol; 7. Previous enrolment in coronary intervention device investigation during the study period; 8. Lesion cannot be covered by 2 longest stents; 9. Restenotic bifurcation lesions； 10. Severe calcification requiring rotational atherectomy; 11. Acute myocardial infarction less than 24 hours; 12. Chronic total occlusion which is not recanalized; 13. Simple bifurcation lesions; 14. Renal failure requiring or during dialysis; 15. Hemoglobin \<9g/L 16. Uncontrolled hypertension (systolic blood pressure≥180 mmHg or diastolic blood pressure≥110 mmHg) 17. Severe heart failure (LVEF\<30%) 18. Combined pre- and post-capillary hypertension (mPAP≥25 mmHg, PCWP\>15 mmHg, and PVR\>3.0 WU) 19. Patients with hypertrophic obstructive cardiomyopathy.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease

Contacts and locations

Locations

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210006, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.