Preventive stenting for vulnerable coronary plaques in ACS patients

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

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.

Why it matters

Who can join: the full rules

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 or VFR, and OCT Inclusion Criteria

1. Successful completion of angiography, QFR or VFR, and OCT examinations
2. Successful treatment of all culprit lesions and flow-limited lesions (QFR or VFR≤ 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 or VFR \>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 it's running

• Beijing Anzhen Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Boqun SHI
• Email: shiboqun@126.com
• Phone: 18801129155

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.