OCT in Endovascular Recanalization of Chronic Carotid Artery Occlusion

NCT07740408 | Active Not Recruiting

• 1 other identifier: IIT-2026-0027
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Internal Carotid Artery Occlusion; Carotid Artery Occlusion

Outcome Measures

Primary Outcomes (1)

• Composite Rate of Procedure-Related Adverse Events

  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)

  7days after operation

Secondary Outcomes (4)

• 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

Eligibility Criteria

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

Study Population

The study population will include adults with symptomatic chronic carotid artery occlusion who are planned for clinically indicated endovascular recanalization and in whom OCT imaging can be performed after the guidewire crosses the occluded segment or after an imaging-capable working channel is established. CCAO will be confirmed by preoperative clinical assessment, including ipsilateral transient ischemic attack or ischemic stroke history and imaging evidence of ipsilateral hypoperfusion, together with noninvasive vascular imaging by CTA or MRA. Atherosclerosis should be the main suspected etiology, with an occlusion duration of at least 3 weeks. Intra-procedural DSA will confirm occlusion morphology before OCT imaging is performed.

You may qualify if:

• 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.

You may not qualify if:

• Intra-procedural clinical condition requires immediate rescue treatment, preventing protocol-defined OCT imaging or safety recording.
• Flow-limiting dissection, vascular rupture, or another serious complication requiring immediate rescue treatment occurs before OCT examination.
• Non-atherosclerotic etiology, including arterial dissection, moyamoya disease, vasculitis, or radiation-induced vascular injury.
• Ipsilateral intracranial large vessel occlusion requiring priority treatment. 5.Severe coagulation disorder, including platelet count \<80 x 10\^9/L or INR \>2.0.
• Known contraindication or severe allergy to iodinated contrast, required peri-procedural antithrombotic medication, or OCT-related flushing or contrast procedures.
• Large cerebral infarction, defined as ASPECTS \<6 or DWI infarct volume \>70 mL.
• 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.
• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, China

Location

Related Publications (10)

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• Shen G, Zhao J, Mao Y, Yu X, Lee KY, Nan G. Optical Coherence Tomography-Guided Stenting for Common Carotid Free-Floating Thrombus. J Endovasc Ther. 2026 Jun;33(3):1548-1552. doi: 10.1177/15266028241270667. Epub 2024 Aug 18.

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Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, professor

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 31, 2026
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 31, 2026

Record last verified: 2025-12

Locations

CN (1)