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Which heart stent strategy saves more lives? a trial puts two methods to the test

NCT ID NCT06218485

Disease control Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial compares two strategies for placing stents in people with coronary artery disease, where arteries that feed the heart become narrowed. One strategy uses a blood-flow measurement called fractional flow reserve to decide whether a stent is needed. The other uses intravascular ultrasound, an imaging tool, to guide the stent placement after that same measurement. Researchers will track participants for up to five years to see which approach leads to fewer deaths, heart attacks, or repeat procedures.

What this could mean

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

Active substance
Two procedural strategies: one uses a blood-flow measurement (fractional flow reserve) to decide whether to place a stent, and the other uses intravascular ultrasound to guide stent placement after that measurement.
What this could lead to
If it works, this could identify the better way to guide stent placement, potentially reducing deaths, heart attacks, and repeat procedures in people with narrowed heart arteries.
What could go wrong
The trial is large but still experimental, and the two strategies may end up with similar outcomes. Risks include complications from the procedures themselves, such as bleeding or damage to the artery.

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 1,942 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Sep 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 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: * Subject must be ≥ 19 years. * Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving invasive physiologic or imaging evaluation and PCI with a drug-eluting stent (DES) and he/she or his/her legally authorized representative provides written informed consent. * Subjects suspected with ischemic heart disease. * Subjects with coronary artery diameter stenosis 50-90% by angiography-based visual estimation eligible for stent implantation. * Target vessel size ≥ 2.5mm in visual estimation. Exclusion Criteria: * Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor * Active pathologic bleeding. * Gastrointestinal or genitourinary major bleeding within the prior 3 months. * History of bleeding diathesis, known coagulopathy. * Non-cardiac co-morbid conditions with life expectancy \< 2 years. * Target lesion located in coronary arterial bypass graft. * Left main coronary artery stenosis ≥ 50%. * Chronic total occlusion in the study target vessel. * Culprit lesion of ST-elevation myocardial infarction (STEMI). * Not eligible for angiography-derived FFR (ostial RCA ≥ 50% stenosis, severe tortuosity, severe overlap, poor image quality).

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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

  • Changxing People's Hospital

    Huzhou, China

  • Chonnam National University Hospital

    Donggu, South Korea

  • Ganzhou People's Hospital

    Ganzhou, China

  • Hangzhou First People's Hospital

    Hangzhou, China

  • Huzhou Central Hospital

    Huzhou, China

  • Inje University Haeundae Paik Hospital

    Busan, South Korea

  • Inje University Ilsan Paik Hospital

    Goyang, South Korea

  • Jinhua Central Hospital

    Jinhua, China

  • Jining No.1 People's Hospital

    Jining, China

  • Keimyung University Dongsan Medical Center

    Daegu, South Korea

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, China

  • Peking University Third Hospital

    Beijing, China

  • Renmin Hospital of Wuhan University

    Wuhan, China

  • Second Affiliated Hospital of Shantou University Medical College

    Guangdong, China

  • Seoul National University Hospital,

    Seoul, South Korea

  • Shanxi Cardiovascular Hospital

    Taiyuan, China

  • Sir Run Run Shaw Hospital

    Hangzhou, China

  • The Affiliated Hospital of Hangzhou Normal University

    Hangzhou, China

  • The Affiliated Hospital of Medical College, Ningbo University

    Ningbo, China

  • The Fifth Affiliated Hospital, Sun Yat-sen University

    Zhuhai, China

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, China

  • The First Affiliated hospital of Wenzhou Medical University

    Wenzhou, China

  • The Fourth People's Hospital of Jinan

    Jinan, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, China

  • The Southwest Hospital of Army Medical University

    Chongqing, China

  • Uijeongbu Eulji Medical Center

    Uijeongbu-si, South Korea

  • Ulsan University Hospital

    Ulsan, South Korea

  • Wuhan Aisa Heart Hospital

    Wuhan, China

  • Xiangya Hospital of Central South University

    Changsha, China

  • Zhejiang Hospital

    Hangzhou, China

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