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

NCT06855537 | Recruiting Phase 4 DMC

• 1 other identifier: 2025-04
• Study Type: interventional
• Target: 2,190
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Arterial Disease (CAD); Vulnerable Coronary Plaques; Thin-cap fIbroatheroma; Acute Coronary Syndromes (ACS)

Keywords

Optical Coherence Tomography (OCT); Percutaneous Coronary Intervention (PCI); Randomized Controlled Trial (RCT); Optimal Medical Therapy; Drug Eluting Stent (DES); Quantitative Flow Ratio (QFR); Acute Coronary Syndromes (ACS); Vulnerable Coronary Plaques

Outcome Measures

Primary Outcomes (1)

• Target vessel failure

  Composite endpoint of cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization, and hospitalization for unstable or worsening angina.

  From enrollment to the end of treatment at 24 months

Secondary Outcomes (10)

• Death

  From enrollment to the end of treatment at 24 months

• Myocardial infarction

  From enrollment to the end of treatment at 24 months

• Revascularization

  From enrollment to the end of treatment at 24 months

• Hospitalization for any cause

  From enrollment to the end of treatment at 24 months

• Intrastent thrombus

  From enrollment to the end of treatment at 24 months

Study Arms (2)

PCI+OMT

EXPERIMENTAL

PCI plus guideline-recommended optimal medical therapy (including intensive lipid-lowering therapy \[LDL\<1.4mmol/l and decreased by 50% compared to the baseline\]).

Procedure: PCI strategy; Drug: OMT strategy

OMT

ACTIVE COMPARATOR

Guideline-recommended optimal medical therapy (including intensive lipid-lowering therapy \[LDL\<1.4mmol/l\] and decreased by 50% compared to the baseline).

Drug: OMT strategy

Interventions

PCI strategy PROCEDURE

-In the intervention group, vulnerable plaque lesions (quantitative flow ratio, QFR \>0.8) to be treated at the operator's discretion using second-generation drug eluting stent (DES).

PCI+OMT

OMT strategy DRUG

* Lifestyle modifications and intensive medical therapy (based on current guideline-directed secondary prevention). * Both groups to receive statin or other therapies to achieve LDL-C \<1.4 mmol/L and decrease by 50% compared to the baseline. * Lifestyle and risk factor management to include smoking cessation, nutritional optimization, physical activity, adherence to prescribed medications, and control of diabetes and hypertension.

OMT; PCI+OMT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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°)

You may not qualify if:

• Patients with contraindications to dual antiplatelet therapy (DAPT) or planning to discontinue DAPT within one year
• Patients with other major illnesses and a life expectancy \<2 years
• Patients scheduled for cardiac surgery or major non-cardiac surgery
• Women who are breastfeeding, pregnant, or planning pregnancy during the study
• Patients with severe heart failure (NYHA class III-IV or Killip class III-IV or left ventricular ejection fraction \<35%)
• Patients with estimated glomerular filtration rate \<30 mL/(min·1.73 m²)
• Patients with allergy to contrast agents or DES drugs
• \. 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Boqun SHI

CONTACT

18801129155; shiboqun@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: March 4, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

CN (1)