Ischemia-guided versus plaque burden and vulnerability-guided revascularization for high-risk coronary artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with high-risk coronary artery disease and angiographic stenoses of 50–90% who meet detailed clinical and lesion criteria will undergo one of two PCI guidance strategies. One arm uses intravascular imaging to target lesions based on plaque burden and vulnerability, while the other arm uses physiologic indices such as FFR/iFR to guide revascularization decisions. Procedures, adjunctive imaging or physiologic measurements, and guideline-directed medical therapy will be used per protocol, with clinical follow-up to capture outcomes. The trial compares clinical event rates and procedural metrics between the two guidance strategies to determine which approach leads to better patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

① Patients aged 19 years or older

② Patients with moderate to severe coronary artery stenosis identified on coronary angiography:

A. Diameter stenosis of 50%-90% by visual estimation B. De novo lesions (newly developed lesions) C. Reference vessel diameter ≥ 2.5 mm by visual estimation

③ Patients with either clinically high-risk features for recurrent ischemic events or complex high-risk lesions identified on angiography:

A. Clinically high-risk features i. Medically treated diabetes mellitus ii. Chronic kidney disease (≥ Stage 3B, eGFR \< 45 mL/min/1.73 m²) iii. Acute coronary syndrome (ACS) iv. Previous myocardial infarction (MI)

B. Complex high-risk lesions i. True bifurcation lesions ii. Calcified lesions (moderate to severe calcification on angiography) iii. Diffuse long lesions (≥ 30 mm in length) iv. Multivessel disease v. Multiple lesions (≥ 3 lesions)

④ Patients who can verbally demonstrate an understanding of the risks, benefits, and alternative treatments of invasive physiologic or imaging assessment and PCI

⑤ Patients who agree to the study protocol and clinical follow-up plan, voluntarily decide to participate, and provide written informed consent to participate in this clinical trial

Exclusion Criteria:

* Hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, prasugrel, ticagrelor, adenosine, or nicorandil

  * Hemodynamic instability requiring mechanical circulatory support (ECMO or IABP)

    * Moderate or severe stenosis of the left main coronary artery (diameter stenosis \> 50%)

      * History of coronary artery bypass grafting (CABG)

        * Severe asthma or severe chronic obstructive pulmonary disease (COPD) ⑥ Active bleeding

          ⑦ Major gastrointestinal or genitourinary bleeding within the previous 3 months

          ⑧ Bleeding diathesis or known coagulopathy, including a history of heparin-induced thrombocytopenia (HIT)

          ⑨ Life expectancy \< 2 years due to non-cardiovascular comorbidities

          ⑩ Inability to provide signed informed consent

          ⑪ Any condition deemed by the investigator to make the patient unsuitable for this clinical trial or likely to increase study-related risks

Where it's running

• Seoul National University Hospital
  Seoul, Main Building, South Korea Recruiting

Study contacts

• Study coordinator: Bon-Kwon Koo, MD., PhD.
• Email: bkkoo@snu.ac.kr
• Phone: 82-2-2072-7433

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.