Preventive stenting for vulnerable coronary plaques in ACS patients

Randomized Controlled Study on the Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques

This trial will test whether adding a preventive percutaneous intervention to optimal medical therapy helps people with acute coronary syndrome who have non-flow-limiting vulnerable coronary plaques.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2190 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Anzhen Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06855537 on ClinicalTrials.gov

What this trial studies

This randomized phase 4 trial enrolls patients with acute coronary syndrome who, after treatment of culprit lesions, are found by OCT to have non-flow-limiting thin-cap fibroatheromas. Participants are randomly assigned to receive preventive percutaneous coronary intervention (PCI) plus optimal medical therapy or to receive optimal medical therapy alone. Angiography, QFR, and OCT are used to select and characterize lesions and to guide the interventional strategy, with PCI performed using contemporary techniques such as drug-eluting stents. Follow-up will compare clinical outcomes and plaque-related events between the two groups to determine if adding intervention improves patient outcomes over medical therapy alone.

Who should consider this trial

Good fit: Ideal candidates are adults 18–80 with acute coronary syndrome who have had culprit lesions treated and who have at least one non-flow-limiting OCT-defined thin-cap fibroatheroma in a 2.5–4.0 mm coronary vessel with lesion length ≤40 mm and QFR >0.80.

Not a fit: Patients with flow-limiting lesions, contraindications to dual antiplatelet therapy, pregnancy, age outside 18–80, or without OCT-defined thin-cap fibroatheroma are unlikely to receive benefit from the preventive interventional approach.

Why it matters

Potential benefit: If successful, adding interventional treatment could reduce future heart attacks or other cardiac events related to vulnerable plaques beyond what medicines and lifestyle changes achieve alone.

How similar studies have performed: Small imaging studies and registries have shown feasibility and possible benefit of targeting vulnerable plaques, but large randomized trials demonstrating clear clinical benefit are still lacking.

Eligibility criteria

Inclusion Criteria Clinical Inclusion Criteria 1. Males or non-pregnant females aged 18-80 years 2. Clinically diagnosed with acute coronary syndrome (including unstable angina, ST-segment elevation myocardial infarction, and non-ST-segment elevation myocardial infarction) 3. Patients willing and able to sign a written informed consent form Angiography, QFR, and OCT Inclusion Criteria

1. Successful completion of angiography, QFR, and OCT examinations
2. Successful treatment of all culprit lesions and flow-limited lesions (QFR ≤ 0.8)
3. Reference vessel diameter between 2.5-4.0 mm on imaging assessment
4. Lesion length ≤40 mm
5. At least one significant stenosis (diameter reduction \>50%) demonstrated by angiography, with QFR \>0.80 and OCT-defined TCFA (fibrous cap thickness \<65μm, lipid arc \>90°)

Exclusion Criteria Clinical Exclusion Criteria

1. Patients with contraindications to dual antiplatelet therapy (DAPT) or planning to discontinue DAPT within one year
2. Patients with other major illnesses and a life expectancy \<2 years
3. Patients scheduled for cardiac surgery or major non-cardiac surgery
4. Women who are breastfeeding, pregnant, or planning pregnancy during the study
5. Patients with severe heart failure (NYHA class III-IV or Killip class III-IV or left ventricular ejection fraction \<35%)
6. Patients with estimated glomerular filtration rate \<30 mL/(min·1.73 m²)
7. Patients with allergy to contrast agents or DES drugs
8. Patients currently enrolled in other clinical studies Angiographic Exclusion Criteria

1\. Patients for whom CABG is the preferred treatment 2. Target lesion is a previously stented lesion 3. Target lesion is a post-bypass lesion 4. Target lesion is a heavily calcified or angulated lesion 5. Target lesion requires dual-stent technique 6. Target lesion is a left main coronary artery lesion.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Anzhen Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Boqun SHI

Conditions Coronary Arterial Disease; Vulnerable Coronary Plaques; Thin-cap fIbroatheroma; Acute Coronary Syndromes; Optical Coherence Tomography; Percutaneous Coronary Intervention; Randomized Controlled Trial; Optimal Medical Therapy