Clin2
NCT06855537Worth exploringRecruiting

Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques

Coronary Arterial Disease (CAD)Vulnerable Coronary PlaquesThin-cap fIbroatheromaAcute Coronary Syndromes (ACS)

Part of Heart & circulation clinical trials.

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.

Summary from the official registry record.

Phase
Phase 4
Enrollment
2,190 people
Ages
18 years to 80 years
Study type
Interventional

Who can take part

  • Successful completion of angiography, QFR or VFR, and OCT examinations
  • Successful treatment of all culprit lesions and flow-limited lesions (QFR or VFR≤ 0.8)
  • Reference vessel diameter between 2.5-4.0 mm on imaging assessment
  • Lesion length ≤40 mm
  • 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°)

View the official record on ClinicalTrials.gov

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Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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