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

Strategic Comparison Of Ischemia-based Versus Plaque Burden and vulnErability-based Revascularization in High-Risk Coronary Artery Disease Patients

This trial tests whether using intravascular plaque imaging to pick which blockages to open works better than using blood-flow (physiology) tests for people with high-risk coronary artery disease and 50–90% artery narrowings.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1944 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Seoul National University Hospital (Academic / other)
• Locations: 1 site (Seoul, Main Building)
• Trial ID: NCT07324720 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 19 or older with 50–90% de novo coronary stenosis in vessels ≥2.5 mm who have clinical high‑risk features (for example diabetes, CKD stage ≥3B, ACS, prior MI) or complex high‑risk lesions are ideal candidates.

Not a fit: People with mild (<50%) or very severe (>90%) stenoses, very small vessels, lesions not suitable for PCI, or who cannot undergo intravascular imaging or physiologic testing are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could help doctors choose which lesions to treat more accurately and reduce heart attacks, repeat procedures, or other cardiac events.

How similar studies have performed: Physiology-guided PCI (FFR/iFR) has established outcome benefits and intravascular imaging has improved procedural results in other studies, but directly comparing plaque vulnerability-guided revascularization with ischemia-guided strategies is relatively novel.

Eligibility criteria

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 this trial is running

Seoul, Main Building

• Seoul National University Hospital — Seoul, Main Building, South Korea (Recruiting)

Study contacts

• Study coordinator: Bon-Kwon Koo, MD., PhD.

Conditions Coronary Artery Disease