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

Launched by BEIJING ANZHEN HOSPITAL · Feb 27, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating whether a special treatment for certain types of coronary artery disease can improve outcomes for patients with vulnerable plaques in their heart arteries. Vulnerable plaques are fatty deposits that can lead to serious heart problems but aren't currently blocking blood flow. The study is trying to find out if adding a specific type of procedure—using advanced stents or balloons—can help patients even more when combined with the best available medications. Participants will be randomly placed into two groups: one that receives the additional procedure along with medication, and another that only receives medication.

To be eligible for this trial, participants should be between 18 and 80 years old, have a recent diagnosis of acute coronary syndrome (a type of heart problem), and have certain heart artery conditions that meet specific criteria. During the trial, those in the experimental group will undergo a procedure to treat their vulnerable plaques and will be closely monitored while taking medications to prevent blood clots. This study is important because it aims to find better ways to manage heart health and prevent serious complications from vulnerable plaques.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 18-80, male or non-pregnant female
• • Clinical diagnosis of ACS
• • Willing and able to provide written informed consent
• • At least one significant stenosis (\>50% diameter stenosis) with FFR or QFR \>0.8, meeting the following: OCT-defined thin-cap fibroatheroma (fibrous cap thickness \<65 μm and lipid arc \>90°)
• • Reference vessel diameter: 2.5-4.0 mm
• • Lesion length ≤ 40 mm
• Exclusion Criteria:
• • Contraindications to dual antiplatelet therapy or planned discontinuation within one year
• • Severe comorbidities with a life expectancy of less than two years
• • Planned cardiac or major non-cardiac surgery
• • Pregnancy, breastfeeding, or planned pregnancy during the study
• • Left ventricular ejection fraction \<35%
• • Estimated glomerular filtration rate \<30 ml/min/1.73m²
• • Allergy to contrast agents, drug-eluting stents, or DEB drugs
• • Participation in other clinical studies
• • Preferred treatment is CABG
• • Severely calcified or angulated target lesion
• • Target lesion requiring dual stent technique
• • Left main disease
• • Previously stented target lesion
• • Target lesion in a graft vessel