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NCT Number: NCT07740408

OCT in Endovascular Recanalization of Chronic Carotid Artery Occlusion

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Renji Hospital

Shanghai, Shanghai Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 >=6.
  • 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.

Exclusion criteria

  • 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 >2.0.

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.

Treatment and study plan

Primary outcomes

  1. Composite Rate of Procedure-Related Adverse Events

    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:

    • OCT-related vascular injury (dissection/perforation on DSA)
    • Distal embolization (angiographic occlusion)
    • Symptomatic intracranial hemorrhage (CT/MRI confirmed with NIHSS increase ≧ 4)
    • Cerebral hyperperfusion syndrome (clinical symptoms + CT perfusion/TCD confirmation)
    • Contrast-induced nephropathy (serum creatinine increase ≧ 25% or ≧0.5 mg /dL from baseline)

Secondary outcomes

  1. Rate of Successful Vessel 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).

  2. Change from Baseline in National Institutes of Health Stroke Scale (NIHSS) Score

    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.

  3. Total Procedural Duration

    Time frame: immediately after operation

    Total time taken to complete the intervention, measured from initial arterial puncture to sheath removal or completion of angiography.

  4. Total Volume of Contrast Medium Administered

    Time frame: immediately after operation

    The cumulative volume of iodinated contrast agent used throughout the procedure.

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Prospective Safety Study of Optical Coherence Tomography During Endovascular Recanalization of Chronic Carotid Artery Occlusion

Acronym: OCT CICAO

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

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.

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