Carotid OcclusionERCAONCT03179774
Endovascular Revascularization for Chronic Carotid Artery Occlusion Trial
A study testing Endovascular revascularization in people with Carotid Occlusion, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Revascularization for carotid artery occlusion (CAO) remained controversial, there is no prospective randomized control trial (RCT) regarding carotid artery stenting (CAS) in CAO patients. The investigators conduct a prospective study composed of clinical registry arm and RCT arm. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Carotid Occlusion
- What is being tested?
- Endovascular revascularization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 May 2017to Dec 2025
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age 20 years or older
- Abnormal cerebral perfusion by CTP or MRI
- No medical history of stroke or transient ischemic attack (TIA) ipsilateral to the carotid occlusion within 90 days of randomization
- Women must not be of childbearing potential or, if of childbearing potential, have a negative pregnancy test prior to randomization.
- Patient age 20 years or older
- Abnormal cerebral perfusion by CTP or MRI
Show all 10Show fewer
- No medical history of stroke or TIA ipsilateral to the carotid occlusion within 90 days of randomization
- Patients must have a modified Rankin Scale (mRS) ≤2 at the time of informed consent.
- Women must not be of childbearing potential or, if of childbearing potential, have a negative pregnancy test prior to randomization.
- Randomization will apply to only 1 carotid artery occlusion for patients with bilateral carotid occlusion. Intervention of the contralateral stenosis, should it exists, may be done in according to clinical indications at least 30 days prior to randomization.
Who cannot join
- Patient has acute stroke within 90 days,
- Intolerance or allergic reaction to a study medication without a suitable management alternative.
- Patient is expected to have the ADP antagonist therapy interruption within 3 months after the procedure.
- GI hemorrhage within 1 month prior to enrollment that would preclude antiplatelet therapy
- Bleeding diathesis
- Intracranial hemorrhage within the past 12 months.
Show all 44Show fewer
- Platelet count <100,000/μl or history of heparin-induced thrombocytopenia.
- Other high-risk cardiac sources of emboli, including left ventricular aneurysm, severe cardiomyopathy, aortic or mitral mechanical heart valve, severe calcific aortic stenosis (valve area < 1.0 cm2), endocarditis, moderate to severe mitral stenosis, left atrial thrombus, or any intracardiac mass, or known unrepaired patent foramen ovale (PFO) with prior paradoxical embolism.
- Any major surgery, major trauma, revascularization procedure within the past 1 month.
- Acute coronary syndrome within the past 1 month or acute coronary syndrome (ACS) that is not amenable to revascularization (patients should undergo planned coronary revascularization at least 30 days before randomization).
- Inability to understand and cooperate with study procedures or provide informed consent.
- Patients with < 5 years life expectancy
- Concomitant vascular conditions precluding endovascular revascularization procedure;
- Previous ipsilateral carotid artery stenting
- Intracranial aneurysm or arteriovenous malformation;
- Educational level lower than elementary school;
- Aphasia or right-sided hemiparesis
- Marked depression.
- Severe dementia.
- Part 2: Randomized control study
- Patient has acute stroke within 90 days,
- Prior major ipsilateral stroke in the past with moderate disability (mRS ≥ 3) that is likely to confound study outcomes.
- Current neurologic illness characterized by fleeting or fixed neurologic deficits that cannot be distinguished from TIA or stroke.
- Patient has significant renal insufficiency with estimated glomerular filtration rate (eGFR) <30 ml/min (at screening). and would not receive renal replacement therapy if contrast agent related nephropathy occurs
- Intolerance or allergic reaction to a study medication without a suitable management alternative.
- Patient is expected to have the ADP antagonist therapy interruption within 3 months after the procedure.
- GI hemorrhage within 1 month prior to enrollment that would preclude antiplatelet therapy
- Bleeding diathesis
- Intracranial hemorrhage within the past 12 months.
- Platelet count <100,000/μl or history of heparin-induced thrombocytopenia.
- Other high-risk cardiac sources of emboli, including left ventricular aneurysm, severe cardiomyopathy, aortic or mitral mechanical heart valve, severe calcific aortic stenosis (valve area < 1.0 cm2), endocarditis, moderate to severe mitral stenosis, left atrial thrombus, or any intracardiac mass, or known unrepaired PFO with prior paradoxical embolism.
- Major (non-carotid) surgery/procedures planned within 3 months after enrollment.
- Any major surgery, major trauma, revascularization procedure within the past 1 month.
- Acute coronary syndrome within the past 1 month or ACS that is not amenable to revascularization (patients should undergo planned coronary revascularization at least 30 days before randomization).
- Coronary artery disease with two or more proximal or major diseased coronary arteries with ≥ 70% stenosis that have not, or cannot, be revascularized.
- Inability to understand and cooperate with study procedures or provide informed consent.
- Patients with < 5 years life expectancy
- Concomitant vascular conditions precluding endovascular revascularization procedure;
- Previous ipsilateral carotid artery stenting
- Intracranial aneurysm or arteriovenous malformation;
- Educational level lower than elementary school;
- Aphasia or right-sided hemiparesis
- Marked depression.
- Severe dementia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Hsien-Li Kao, MD, hsienli_kao@yahoo.com
About this study
Official title: Endovascular Revascularization for Chronic Carotid Artery Occlusion Trial (ERCAO Trial) Part 1: Prospective Clinical Registry Study Part 2: Prospective Randomized Control Trial Study
Revascularization for carotid artery occlusion (CAO) remained controversial, there is no prospective randomized control trial (RCT) regarding carotid artery stenting (CAS) in CAO patients. The investigators conduct a prospective study composed of clinical registry arm and RCT arm. The main purpose of the study is investigate neurocognitive function at 3 months and thereafter up to 12 months.
Read the detailed description
Carotid artery stenosis is an important cause of stroke. Carotid artery stenting (CAS) provides non-inferior clinical outcome comparing to carotid endarterectomy (CEA). However, revascularization for carotid artery occlusion (CAO) remained controversial, owing to failed extracranial-to-intracranial (EC-IC) artery bypass trials, anatomical hindrance for CEA, and technical limitation for CAS. In the past 10 years, the investigators devoted in endovascular therapy for CAO and published innovative and pilot study results regarding feasibility of CAS for CAO, neurocognitive function (NCF) improvement after successful CAS for CAO, and predictors for CAS success in CAO, all in high-ranking journals. Moreover, successful CAS for CAO would lead to lower mortality and stroke rate during long-term follow-up, according to the preliminary analysis from the investigators. However, there is no prospective randomized control trial (RCT) regarding CAS in CAO patients, and in fact, most of the CAS trials excluded CAO.
The investigators, with the largest volume and experience in CAO recanalization in the world, felt obliged and responsible to propose the following RCT to evaluate endovascular revascularization for chronic CAO.
The study composed of two parts. The first part composed of prospective clinical registry for CAO. The second part compose of a prospective superiority trial, rater blinded, with 1:1 randomization to evaluate the clinical efficacy of interventional therapy for CAO. Eligible candidates for CAO revealed by CT, ultrasonography, angiography, or magnetic resonance imaging (MRI), with abnormal brain perfusion demonstrated by CT perfusion study (CTP) or MRI, will be enrolled in to study. If the participants agreed for randomization, participants will be randomized into 2 groups: the optimal medical therapy (OMT) group and the endovascular revascularization plus optimal medical therapy (ER+OMT) group. The primary end-point of the trial is the NCF improvement at 3 months and thereafter up to 12 months. The secondary endpoint includes: cumulative incidence of death and stroke within 30 days after the procedure; death or ipsilateral stroke between 31 days and 1 year; major stroke, ischemic stroke, or hemorrhagic stroke within 30 days after the procedure; major stroke, ischemic stroke, or hemorrhagic stroke between 31 days and 1 year; cognitive function measured by CANTAB; change of cerebral perfusion measured by CTP; target vessel revascularization rate; technique success rate; procedure success rate; and major procedure complication.
- Conditions
- Carotid Occlusion
- Being tested
- Endovascular revascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular revascularizationDevice
Also called Carotid artery stenting
All interventions will be performed via 8F femoral sheath. Target common carotid artery will be engaged with 8F JR 4 guiding catheter. Intra-luminal wiring using coronary guidewires and microcatheters or alternative subintimal tracking with antegrade re-entry technique. Wiring would be abandoned after 30 minutes of futile effort, consumption of more than 300 ml of contrast, or when the wire tip is confirmed to be extravascular. Once wire enters distal true lumen, the microcatheter was exchanged to a 1.5 mm diameter coronary balloon for pre-dilatation. Distal embolic protection device would be deployed if an adequate landing zone can be identified. Properly sized balloon expandable stents and self-expanding stents were then deployed to scaffold the occlusion. Balloon post-dilatation may be done if stent expansion was inadequate.
| Study group | Role | What they receive |
|---|---|---|
| Clinical registry-ER and OMT | Experimental | In clinical registry setting, participants who selected Endovascular revascularization and optimal medical therapy as the treatment for carotid artery occlusion are enrolled. Receives: Device: Endovascular revascularization |
| Clinical registry-OMT | No intervention | In clinical registry setting, participants who selected optimal medical therapy as the treatment for carotid artery occlusion are enrolled. |
| RCT-ER and OMT | Experimental | In randomized control trial setting, participants who are randomized to received endovascular revascularization and optimal medical therapy for carotid artery occlusion are enrolled. Receives: Device: Endovascular revascularization |
| RCT-OMT | No intervention | In randomized control trial setting, participants who are randomized to received optimal medical therapy for carotid artery occlusion are enrolled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
NCF improvement by Alzheimer Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
Neurocognitive function was evaluated by ADAS-Cog
Measured: at 3 months and thereafter up to 12 months
NCF improvement by Mini-Mental State Examination (MMSE)
Neurocognitive function was evaluated by MMSE.
Measured: at 3 months and thereafter up to 12 months
NCF improvement by verbal fluency test
Neurocognitive function was evaluated verbal fluency test
Measured: at 3 months and thereafter up to 12 months
NCF improvement by verbal fluency test Color Trails Test Parts 1
Neurocognitive function was evaluated by Color Trails Test Parts 1
Measured: at 3 months and thereafter up to 12 months
NCF improvement by verbal fluency test Color Trails Test Parts 2
Neurocognitive function was evaluated by Color Trails Test Parts 2
Measured: at 3 months and thereafter up to 12 months
Secondary outcomes (7)
Death and stroke
Cumulative incidence of death and ipsilateral stroke
Measured: within 30 days after the procedure and between 31 days and 1 year
Major stroke, ischemic stroke, or hemorrhagic stroke
Cumulative incidence of major stroke, ischemic stroke, or hemorrhagic stroke
Measured: within 30 days after the procedure and between 31 days and 1 year
Cambridge Neuropsychological Test Automated Battery (CANTAB)
The CANTAB is a computerized test battery for cognitive function evaluation which has been validated and widely used worldwide. CANTAB tests are simple to administer and show strong correlations to brain constructs and known deficits in various disorders, as well as high sensitivity to interventions and small changes over time. It is designed to be administered by trained psychologists with standardized procedures. Tasks of the CANTAB involving practice and attention, memory, executive function and decision making would be administered to all the participants in this study.
Measured: at 3 months and thereafter up to 12 months
Change of cerebral perfusion
Change of cerebral perfusion measured by CT perfusion
Measured: at 3 months and thereafter up to 12 months
Target vessel revascularization rate
Target vessel revascularization rate
Measured: one year
Technique success rate
Technique success is defined if the occlusion segment was recanalized with final residual diameter stenosis of <20%, and establishing grade 3 antegrade Thrombolysis in Cerebral Infarction (TICI) flow.
Measured: 30 days
Procedure success rate
Procedure success: the occlusion segment was stented with final residual diameter stenosis of <20%, and establishing grade 3 antegrade TICI flow and without periprocedural complications.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start17 May 2017
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid OcclusionStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1: Clinical registry study (Optimal medical therapy group vs. Endovascular revascularization and optimal medical therapy) Part 2: Randomized control trial (Optimal medical therapy group vs. Endovascular revascularization and optimal medical therapy)
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsien-Li Kao, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179774
- Sponsor's protocol ID
- 201702049RINA
- Acronym
- ERCAO
- Status last verified
- Jul 2025
- First submitted
- 28 May 2017
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Revascularization for Chronic Carotid Artery Occlusion Trial (ERCAO Trial) Part 1: Prospective Clinical Registry Study Part 2: Prospective Randomized Control Trial Study
- ClinicalTrials.gov ID
- NCT03179774
- Acronym / sponsor ID
- ERCAO / 201702049RINA
- Conditions
- Carotid Occlusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 17 May 2017 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 Jun 2017 (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.
Revascularization for carotid artery occlusion (CAO) remained controversial, there is no prospective randomized control trial (RCT) regarding carotid artery stenting (CAS) in CAO patients. The investigators conduct a prospective study composed of clinical registry arm and RCT arm. The main purpose of the study is investigate neurocognitive function at 3 months and thereafter up to 12 months.
Detailed description
Carotid artery stenosis is an important cause of stroke. Carotid artery stenting (CAS) provides non-inferior clinical outcome comparing to carotid endarterectomy (CEA). However, revascularization for carotid artery occlusion (CAO) remained controversial, owing to failed extracranial-to-intracranial (EC-IC) artery bypass trials, anatomical hindrance for CEA, and technical limitation for CAS. In the past 10 years, the investigators devoted in endovascular therapy for CAO and published innovative and pilot study results regarding feasibility of CAS for CAO, neurocognitive function (NCF) improvement after successful CAS for CAO, and predictors for CAS success in CAO, all in high-ranking journals. Moreover, successful CAS for CAO would lead to lower mortality and stroke rate during long-term follow-up, according to the preliminary analysis from the investigators. However, there is no prospective randomized control trial (RCT) regarding CAS in CAO patients, and in fact, most of the CAS trials excluded CAO.
The investigators, with the largest volume and experience in CAO recanalization in the world, felt obliged and responsible to propose the following RCT to evaluate endovascular revascularization for chronic CAO.
The study composed of two parts. The first part composed of prospective clinical registry for CAO. The second part compose of a prospective superiority trial, rater blinded, with 1:1 randomization to evaluate the clinical efficacy of interventional therapy for CAO. Eligible candidates for CAO revealed by CT, ultrasonography, angiography, or magnetic resonance imaging (MRI), with abnormal brain perfusion demonstrated by CT perfusion study (CTP) or MRI, will be enrolled in to study. If the participants agreed for randomization, participants will be randomized into 2 groups: the optimal medical therapy (OMT) group and the endovascular revascularization plus optimal medical therapy (ER+OMT) group. The primary end-point of the trial is the NCF improvement at 3 months and thereafter up to 12 months. The secondary endpoint includes: cumulative incidence of death and stroke within 30 days after the procedure; death or ipsilateral stroke between 31 days and 1 year; major stroke, ischemic stroke, or hemorrhagic stroke within 30 days after the procedure; major stroke, ischemic stroke, or hemorrhagic stroke between 31 days and 1 year; cognitive function measured by CANTAB; change of cerebral perfusion measured by CTP; target vessel revascularization rate; technique success rate; procedure success rate; and major procedure complication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Part 1: Clinical registry study (Optimal medical therapy group vs. Endovascular revascularization and optimal medical therapy) Part 2: Randomized control trial (Optimal medical therapy group vs. Endovascular revascularization and optimal medical therapy)
| Arm | Type | Receives |
|---|---|---|
| Clinical registry-ER and OMT | Experimental | Device: Endovascular revascularizationIn clinical registry setting, participants who selected Endovascular revascularization and optimal medical therapy as the treatment for carotid artery occlusion are enrolled. |
| Clinical registry-OMT | No intervention | –In clinical registry setting, participants who selected optimal medical therapy as the treatment for carotid artery occlusion are enrolled. |
| RCT-ER and OMT | Experimental | Device: Endovascular revascularizationIn randomized control trial setting, participants who are randomized to received endovascular revascularization and optimal medical therapy for carotid artery occlusion are enrolled. |
| RCT-OMT | No intervention | –In randomized control trial setting, participants who are randomized to received optimal medical therapy for carotid artery occlusion are enrolled. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient age 20 years or older
- Abnormal cerebral perfusion by CTP or MRI
- No medical history of stroke or transient ischemic attack (TIA) ipsilateral to the carotid occlusion within 90 days of randomization
- Women must not be of childbearing potential or, if of childbearing potential, have a negative pregnancy test prior to randomization.
- Patient age 20 years or older
Key exclusion criteria (44 listed)
- Patient has acute stroke within 90 days,
- Intolerance or allergic reaction to a study medication without a suitable management alternative.
- Patient is expected to have the ADP antagonist therapy interruption within 3 months after the procedure.
- GI hemorrhage within 1 month prior to enrollment that would preclude antiplatelet therapy
- Bleeding diathesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular revascularizationAlso: Carotid artery stentingAll interventions will be performed via 8F femoral sheath. Target common carotid artery will be engaged with 8F JR 4 guiding catheter. Intra-luminal wiring using coronary guidewires and microcatheters or alternative subintimal tracking with antegrade re-entry technique. Wiring would be abandoned after 30 minutes of futile effort, consumption of more than 300 ml of contrast, or when the wire tip is confirmed to be extravascular. Once wire enters distal true lumen, the microcatheter was exchanged to a 1.5 mm diameter coronary balloon for pre-dilatation. Distal embolic protection device would be deployed if an adequate landing zone can be identified. Properly sized balloon expandable stents and self-expanding stents were then deployed to scaffold the occlusion. Balloon post-dilatation may be done if stent expansion was inadequate. | Device | Clinical registry-ER and OMT, RCT-ER and OMT |
Primary outcome
NCF improvement by Alzheimer Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
Time frame: at 3 months and thereafter up to 12 months
Neurocognitive function was evaluated by ADAS-Cog
NCF improvement by Mini-Mental State Examination (MMSE)
Time frame: at 3 months and thereafter up to 12 months
Neurocognitive function was evaluated by MMSE.
NCF improvement by verbal fluency test
Time frame: at 3 months and thereafter up to 12 months
Neurocognitive function was evaluated verbal fluency test
NCF improvement by verbal fluency test Color Trails Test Parts 1
Time frame: at 3 months and thereafter up to 12 months
Neurocognitive function was evaluated by Color Trails Test Parts 1
NCF improvement by verbal fluency test Color Trails Test Parts 2
Time frame: at 3 months and thereafter up to 12 months
Neurocognitive function was evaluated by Color Trails Test Parts 2
7 secondary outcomes
Death and stroke
Time frame: within 30 days after the procedure and between 31 days and 1 year
Major stroke, ischemic stroke, or hemorrhagic stroke
Time frame: within 30 days after the procedure and between 31 days and 1 year
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: at 3 months and thereafter up to 12 months
Change of cerebral perfusion
Time frame: at 3 months and thereafter up to 12 months
Target vessel revascularization rate
Time frame: one year
Technique success rate
Time frame: 30 days
Procedure success rate
Time frame: 30 days
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 28 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Hsien-Li Kao, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular revascularization in people with Carotid Occlusion, run by National Taiwan University Hospital at 1 site in Taiwan.
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 10 inclusion and 44 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: looking for participants now, as of the sponsor's last update on 28 Jul 2025. 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 Taiwan. 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?
Contact Hsien-Li Kao, MD (+886-2-2312-3456 ext. 65874, hsienli_kao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NCF improvement by Alzheimer Disease Assessment Scale-Cognitive subscale (ADAS-Cog) (time frame: at 3 months and thereafter up to 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2025.