Actively Recruiting
Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques
Led by Beijing Anzhen Hospital · Updated on 2025-12-02
2190
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this clinical trial is to explore the optimal preventative treatment strategy for non-flow-limiting vulnerable plaques. The main question it aims to answer is: Can interventional therapy further improve the outcome of non-flow-limiting vulnerable plaques on top of optimal pharmacologic therapy? Researchers will randomly assign patients who meet the inclusion criteria to preventative intervention plus optimal drug therapy (experimental group) or optimal drug therapy alone (control group). Participants will: Assigned to the control group: optimized drug therapy consisting of lifestyle improvement and intensive drug therapy including high-dose statin or other therapy to achieve target levels (low-density lipoprotein cholesterol \<1.4 mmol/L and decreased by 50% compared to the baseline). Lifestyle improvement and risk factor management included smoking cessation, nutritional optimization, physical activity, compliance with prescribed medications, and control of diabetes and hypertension. Assigned to the experimental group: all non-flow-limiting vulnerable plaques were treated with conventional second-generation drug-eluting stents. After the procedure, participants received dual antiplatelet therapy for about 12 months as well as other medications in the control group.
CONDITIONS
Official Title
Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or non-pregnant females aged 18 to 80 years
- Diagnosed with acute coronary syndrome, including unstable angina, ST-segment elevation myocardial infarction, or non-ST-segment elevation myocardial infarction
- Willing and able to sign a written informed consent form
- Successful completion of angiography, quantitative flow ratio (QFR), and optical coherence tomography (OCT) examinations
- Successful treatment of all culprit and flow-limited lesions (QFR 0.8)
- Reference vessel diameter between 2.5 and 4.0 mm on imaging
- Lesion length 40 mm or less
- At least one significant stenosis (diameter reduction >50%) with QFR >0.80 and OCT-defined thin-cap fibroatheroma (fibrous cap thickness <65 bcm, lipid arc >906)
You will not qualify if you...
- Contraindications to dual antiplatelet therapy or plans to stop it within one year
- Other major illnesses with life expectancy less than 2 years
- Scheduled for cardiac surgery or major non-cardiac surgery
- Women who are breastfeeding, pregnant, or planning pregnancy during the study
- Severe heart failure (NYHA class III-IV or Killip class III-IV) or left ventricular ejection fraction below 35%
- Estimated glomerular filtration rate less than 30 mL/(min3.73 m8)
- Allergy to contrast agents or drug-eluting stent drugs
- Currently enrolled in other clinical studies
- Cases where coronary artery bypass grafting is preferred
- Target lesion previously stented, post-bypass lesion, heavily calcified or angulated lesion
- Lesion requiring dual-stent technique
- Left main coronary artery lesion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
B
Boqun SHI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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