Chronic Internal Carotid Artery OcclusionOCT CICAONCT07740408
OCT in Endovascular Recanalization of Chronic Carotid Artery Occlusion
An observational study of Chronic Internal Carotid Artery Occlusion and Carotid Artery Occlusion, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Internal Carotid Artery Occlusion, Carotid Artery Occlusion
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 Dec 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Safety Study of Optical Coherence Tomography During 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.
Read the detailed description
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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)
Measured: 7days after operation
Secondary outcomes (4)
Rate of Successful Vessel Recanalization
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).
Measured: immediately after operation
Change from Baseline in National Institutes of Health Stroke Scale (NIHSS) Score
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.
Measured: immediately after operation
Total Procedural Duration
Total time taken to complete the intervention, measured from initial arterial puncture to sheath removal or completion of angiography.
Measured: immediately after operation
Total Volume of Contrast Medium Administered
The cumulative volume of iodinated contrast agent used throughout the procedure.
Measured: immediately after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Jul 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Internal Carotid Artery OcclusionStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jieqing Wan, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740408
- Sponsor's protocol ID
- IIT-2026-0027
- Acronym
- OCT CICAO
- Status last verified
- Dec 2025
- First submitted
- 20 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7. doi: 10.1016/S0140-6736(07)61602-X.
PubMed 18064739Ortega-Gutierrez S, Galecio-Castillo M, Zevallos CB, Rodriguez-Calienes A, Vivanco-Suarez J, Weng J, Samaniego EA, Farooqui M, Derdeyn C. Endovascular Surgery Revascularization of Chronic Cervical Carotid Occlusions: Systematic Review and Meta-Analysis. Stroke Vasc Interv Neurol. 2023 Jun 14;4(1):e000882. doi: 10.1161/SVIN.123.000882. eCollection 2024 Jan.
PubMed 41586040Myrcha P, Gloviczki P. A systematic review of endovascular treatment for chronic total occlusion of the internal carotid artery. Ann Transl Med. 2021 Jul;9(14):1203. doi: 10.21037/atm-20-6980.
PubMed 34430644Cagnazzo F, Lefevre PH, Derraz I, Dargazanli C, Gascou G, Riquelme C, Ahmed R, Bonafe A, Costalat V. Endovascular recanalization of chronically occluded internal carotid artery. J Neurointerv Surg. 2020 Oct;12(10):946-951. doi: 10.1136/neurintsurg-2019-015701. Epub 2020 Jan 31.
PubMed 32005762Persoon S, Luitse MJ, de Borst GJ, van der Zwan A, Algra A, Kappelle LJ, Klijn CJ. Symptomatic internal carotid artery occlusion: a long-term follow-up study. J Neurol Neurosurg Psychiatry. 2011 May;82(5):521-6. doi: 10.1136/jnnp.2010.208330. Epub 2010 Sep 30.
PubMed 20884678Eriksen E, Herstad J, Pertiwi KR, Tuseth V, Nordrehaug JE, Bleie O, van der Wal AC. Thrombus characteristics evaluated by acute optical coherence tomography in ST elevation myocardial Infarction. PLoS One. 2022 Apr 11;17(4):e0266634. doi: 10.1371/journal.pone.0266634. eCollection 2022.
PubMed 35404941Gao Y, Um CY, Fedirko V, Rutherford RE, Seabrook ME, Barry EL, Baron JA, Bostick RM. Effects of supplemental vitamin D and calcium on markers of proliferation, differentiation, and apoptosis in the normal colorectal mucosa of colorectal adenoma patients. PLoS One. 2018 Dec 17;13(12):e0208762. doi: 10.1371/journal.pone.0208762. eCollection 2018.
PubMed 30557404Penisson M, Ladewig J, Belvindrah R, Francis F. Genes and Mechanisms Involved in the Generation and Amplification of Basal Radial Glial Cells. Front Cell Neurosci. 2019 Aug 20;13:381. doi: 10.3389/fncel.2019.00381. eCollection 2019.
PubMed 31481878de Donato G, Pasqui E, Alba G, Giannace G, Panzano C, Cappelli A, Setacci C, Palasciano G. Clinical considerations and recommendations for OCT-guided carotid artery stenting. Expert Rev Cardiovasc Ther. 2020 Apr;18(4):219-229. doi: 10.1080/14779072.2020.1756777. Epub 2020 Apr 24.
PubMed 32294392Shen 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.
PubMed 39155609
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Safety Study of Optical Coherence Tomography During Endovascular Recanalization of Chronic Carotid Artery Occlusion
- ClinicalTrials.gov ID
- NCT07740408
- Acronym / sponsor ID
- OCT CICAO / IIT-2026-0027
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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: 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)
4 secondary outcomes
Rate of Successful Vessel Recanalization
Time frame: immediately after operation
Change from Baseline in National Institutes of Health Stroke Scale (NIHSS) Score
Time frame: immediately after operation
Total Procedural Duration
Time frame: immediately after operation
Total Volume of Contrast Medium Administered
Time frame: immediately after operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Background: PubMed 18064739von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7. doi: 10.1016/S0140-6736(07)61602-X.
- Background: PubMed 41586040Ortega-Gutierrez S, Galecio-Castillo M, Zevallos CB, Rodriguez-Calienes A, Vivanco-Suarez J, Weng J, Samaniego EA, Farooqui M, Derdeyn C. Endovascular Surgery Revascularization of Chronic Cervical Carotid Occlusions: Systematic Review and Meta-Analysis. Stroke Vasc Interv Neurol. 2023 Jun 14;4(1):e000882. doi: 10.1161/SVIN.123.000882. eCollection 2024 Jan.
- Background: PubMed 34430644Myrcha P, Gloviczki P. A systematic review of endovascular treatment for chronic total occlusion of the internal carotid artery. Ann Transl Med. 2021 Jul;9(14):1203. doi: 10.21037/atm-20-6980.
- Background: PubMed 32005762Cagnazzo F, Lefevre PH, Derraz I, Dargazanli C, Gascou G, Riquelme C, Ahmed R, Bonafe A, Costalat V. Endovascular recanalization of chronically occluded internal carotid artery. J Neurointerv Surg. 2020 Oct;12(10):946-951. doi: 10.1136/neurintsurg-2019-015701. Epub 2020 Jan 31.
- Background: PubMed 20884678Persoon S, Luitse MJ, de Borst GJ, van der Zwan A, Algra A, Kappelle LJ, Klijn CJ. Symptomatic internal carotid artery occlusion: a long-term follow-up study. J Neurol Neurosurg Psychiatry. 2011 May;82(5):521-6. doi: 10.1136/jnnp.2010.208330. Epub 2010 Sep 30.
- Background: PubMed 35404941Eriksen E, Herstad J, Pertiwi KR, Tuseth V, Nordrehaug JE, Bleie O, van der Wal AC. Thrombus characteristics evaluated by acute optical coherence tomography in ST elevation myocardial Infarction. PLoS One. 2022 Apr 11;17(4):e0266634. doi: 10.1371/journal.pone.0266634. eCollection 2022.
- Background: PubMed 30557404Gao Y, Um CY, Fedirko V, Rutherford RE, Seabrook ME, Barry EL, Baron JA, Bostick RM. Effects of supplemental vitamin D and calcium on markers of proliferation, differentiation, and apoptosis in the normal colorectal mucosa of colorectal adenoma patients. PLoS One. 2018 Dec 17;13(12):e0208762. doi: 10.1371/journal.pone.0208762. eCollection 2018.
- Background: PubMed 31481878Penisson M, Ladewig J, Belvindrah R, Francis F. Genes and Mechanisms Involved in the Generation and Amplification of Basal Radial Glial Cells. Front Cell Neurosci. 2019 Aug 20;13:381. doi: 10.3389/fncel.2019.00381. eCollection 2019.
- Background: PubMed 32294392de Donato G, Pasqui E, Alba G, Giannace G, Panzano C, Cappelli A, Setacci C, Palasciano G. Clinical considerations and recommendations for OCT-guided carotid artery stenting. Expert Rev Cardiovasc Ther. 2020 Apr;18(4):219-229. doi: 10.1080/14779072.2020.1756777. Epub 2020 Apr 24.
- Background: PubMed 39155609Shen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Internal Carotid Artery Occlusion and Carotid Artery Occlusion, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Rate of Procedure-Related Adverse Events (time frame: 7days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07740408, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.