Prospective Safety Study of Optical Coherence Tomography During Endovascular Recanalization of Chronic Carotid Artery Occlusion
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Composite Rate of Procedure-Related Adverse Events
研究概览
简要总结
Chronic carotid artery occlusion is an important cause of ischemic stroke. Even with best medical therapy, patients with symptomatic disease may continue to have recurrent ipsilateral transient ischemic attack or ischemic stroke and may have a substantial burden of cognitive decline. Advances in guidewires, microcatheters, distal protection devices, and endovascular techniques have improved the technical success of CCAO recanalization; however, the overall clinical benefit of endovascular therapy appears highly dependent on patient selection and intra-procedural decision-making.
During endovascular recanalization, once the guidewire crosses the occluded segment, the operator often must determine whether intraluminal thrombus, dissection, plaque debris, or other lesions are present. Digital subtraction angiography is essential for lumen and flow assessment but cannot reliably characterize the tissue composition or age of intraluminal filling defects. OCT provides high-resolution intraluminal imaging and may improve thrombus identification and lesion assessment in this setting.
详细描述
OCT is one of the highest-resolution intravascular imaging modalities, with axial resolution in the range of approximately 10-20 um. Compared with intravascular ultrasound, OCT can more clearly demonstrate vessel wall layering, plaque components, thrombus surface morphology, signal attenuation, and intraluminal structural detail. In carotid intervention, published clinical experience suggests that OCT may help define thrombus boundaries, characterize thrombus morphology, guide stent landing zones, inform use of protection devices, and support peri-procedural antithrombotic decisions.
The clinical value of OCT thrombus typing remains incompletely established. Coronary OCT studies have reported good discrimination of thrombus type using image attenuation, backscatter, and grayscale parameters, whereas other studies comparing acute OCT findings with histopathology have not confirmed reliable prediction of thrombus composition or freshness. These conflicting data indicate that OCT thrombus classification should be validated prospectively within the specific clinical context of CCAO recanalization rather than extrapolated from coronary studies or isolated case reports.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years, male or female.
- •Symptomatic chronic carotid artery occlusion, with atherosclerosis as the main etiology and disease duration of at least 3 weeks.
- •Persistent symptoms despite best medical therapy, including ipsilateral TIA or stroke, or imaging evidence of ipsilateral hypoperfusion.
- •Clinically planned endovascular recanalization procedure in which the guidewire successfully crosses the occluded segment.
- •Intra-procedural OCT intraluminal imaging is planned or completed.
- •The operator judges that OCT imaging will not substantially increase immediate rescue risk and that peri-procedural safety observation can be completed.
- •Baseline mRS score 0-2, NIHSS <=15, and ASPECTS >=
- •Target vessel anatomy can support endovascular recanalization and stent therapy if clinically necessary.
- •Written informed consent has been signed before the procedure and includes OCT imaging and follow-up requirements.
排除标准
- •1.Intra-procedural clinical condition requires immediate rescue treatment, preventing protocol-defined OCT imaging or safety recording.
- •2.Flow-limiting dissection, vascular rupture, or another serious complication requiring immediate rescue treatment occurs before OCT examination.
- •3.Non-atherosclerotic etiology, including arterial dissection, moyamoya disease, vasculitis, or radiation-induced vascular injury.
- •4.Ipsilateral intracranial large vessel occlusion requiring priority treatment. 5.Severe coagulation disorder, including platelet count <80 x 10^9/L or INR >2.
- •6.Known contraindication or severe allergy to iodinated contrast, required peri-procedural antithrombotic medication, or OCT-related flushing or contrast procedures.
- •7.Large cerebral infarction, defined as ASPECTS <6 or DWI infarct volume >70 mL.
- •8.Severe target vessel calcification or tortuosity such that the OCT catheter is not expected to pass safely or the recanalization risk is judged to be extremely high.
- •9.eGFR <30 mL/min or severe hepatic dysfunction. 10.Life expectancy <12 months. 11.Pregnancy or lactation. 12.Current participation in another conflicting clinical study that may affect outcome assessment.
结局指标
主要结局
Composite Rate of Procedure-Related Adverse Events
时间窗: 7days after operation
Percentage of participants experiencing one or more of the following procedure-related complications during or after OCT-guided CCAO recanalization: 1. OCT-related vascular injury (dissection/perforation on DSA) 2. Distal embolization (angiographic occlusion) 3. Symptomatic intracranial hemorrhage (CT/MRI confirmed with NIHSS increase ≧ 4） 4. Cerebral hyperperfusion syndrome (clinical symptoms + CT perfusion/TCD confirmation) 5. Contrast-induced nephropathy (serum creatinine increase ≧ 25% or ≧0.5 mg /dL from baseline)
次要结局
- Rate of Successful Vessel Recanalization(immediately after operation)
- Change from Baseline in National Institutes of Health Stroke Scale (NIHSS) Score(immediately after operation)
- Total Procedural Duration(immediately after operation)
- Total Volume of Contrast Medium Administered(immediately after operation)
研究者
Jieqing Wan
MD, PhD, professor
RenJi Hospital