Renji Hospital
Shanghai, Shanghai Municipality, China
NCT Number: NCT07740408
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–80 year
All sexes
Observational
Shanghai, Shanghai Municipality, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 >2.0.
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.
Time frame: 7days after operation
Percentage of participants experiencing one or more of the following procedure-related complications during or after OCT-guided CCAO recanalization:
Time frame: immediately after operation
Percentage of participants achieving successful recanalization of the chronically occluded internal carotid artery, defined as Modified Treatment in Cerebral Ischemia (mTICI) grade 2b or 3, assessed by post-procedural Digital Subtraction Angiography (DSA).
Time frame: immediately after operation
Mean change in NIHSS score to measure the severity of stroke-related neurological deficits. The total score ranges from 0 to 42, where higher scores indicate more severe neurological impairment.
Time frame: immediately after operation
Total time taken to complete the intervention, measured from initial arterial puncture to sheath removal or completion of angiography.
Time frame: immediately after operation
The cumulative volume of iodinated contrast agent used throughout the procedure.
RenJi Hospital
Other
Prospective Safety Study of Optical Coherence Tomography During Endovascular Recanalization of Chronic Carotid Artery Occlusion
Acronym: OCT CICAO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07396025
Arterial Occlusive Diseases, Arteriosclerosis
Astana, Kazakhstan
View Trial DetailsNCT06702644
Carotid Artery Occlusion
View Trial DetailsNCT01758614
Brain Diseases, Brain Infarction
Beijing, Beijing Municipality, China
View Trial Details