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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Successful completion of angiography, QFR, and OCT examinations

• Successful treatment of all culprit lesions and flow-limited lesions (QFR ≤ 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 \>0.80 and OCT-defined TCFA (fibrous cap thickness \<65μm, lipid arc \>90°)

Locations
Other Locations
China
Beijing Anzhen Hospital
RECRUITING
Beijing
Contact Information
Primary
Boqun SHI
shiboqun@126.com
18801129155
Time Frame
Start Date: 2025-11-03
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 2190
Treatments
Experimental: PCI+OMT
PCI plus guideline-recommended optimal medical therapy (including intensive lipid-lowering therapy \[LDL\<1.4mmol/l and decreased by 50% compared to the baseline\]).
Active_comparator: OMT
Guideline-recommended optimal medical therapy (including intensive lipid-lowering therapy \[LDL\<1.4mmol/l\] and decreased by 50% compared to the baseline).
Related Therapeutic Areas
Sponsors
Leads: Beijing Anzhen Hospital

This content was sourced from clinicaltrials.gov

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