NCT06855537RecruitingPhase 4
Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques
Randomized Controlled Study on the Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 2190 (estimated)
- First submitted
- 13 Jan 2025
- Start date
- 3 Nov 2025
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- Beijing Anzhen Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT06855537
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 2190
- From 3 Nov 2025 to the primary completion date, 1 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with contraindications to dual antiplatelet therapy (DAPT) or planning to discontinue DAPT within one year
- Patients currently enrolled in other clinical studies Angiographic Exclusion Criteria
- 1\. 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.
Other illness
- Patients scheduled for cardiac surgery or major non-cardiac surgery
- Patients with allergy to contrast agents or DES drugs
Lab values
- Patients with severe heart failure (NYHA class III-IV or Killip class III-IV or left ventricular ejection fraction \<35%)
Age
- Patients with other major illnesses and a life expectancy \<2 years
Other
- Women who are breastfeeding, pregnant, or planning pregnancy during the study
- Patients with estimated glomerular filtration rate \<30 mL/(min·1.73 m²)
Who the study is looking for
- 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°)
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anzhen Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.