Endovascular treatment for blocked carotid arteries

Endovascular Revascularization for Chronic Carotid Artery Occlusion Trial (ERCAO Trial) Part 1: Prospective Clinical Registry Study Part 2: Prospective Randomized Control Trial Study

This study is testing if a new procedure to open blocked carotid arteries can help improve brain function in patients with chronic artery blockages.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: National Taiwan University Hospital (Academic / other)
• Locations: 1 site (Taipei)
• Trial ID: NCT03179774 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of endovascular revascularization for patients with chronic carotid artery occlusion (CAO). It includes a clinical registry and a randomized control trial to assess neurocognitive function over a period of 12 months. The study aims to provide evidence for the safety and efficacy of carotid artery stenting (CAS) in improving outcomes for CAO patients, addressing a gap in existing research. The investigators have significant experience in this area and have previously published promising results regarding the feasibility and potential benefits of CAS for CAO.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 years or older with abnormal cerebral perfusion and no recent history of stroke or transient ischemic attack.

Not a fit: Patients with recent strokes, certain bleeding disorders, or those who cannot tolerate antiplatelet therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with chronic carotid artery occlusion.

How similar studies have performed: While there have been no prior randomized control trials specifically for carotid artery stenting in CAO patients, preliminary studies suggest potential benefits, making this approach novel.

Eligibility criteria

Part 1: Clinical registry study

Inclusion criteria for clinical registry study

* 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.

Exclusion Criteria for clinical registry study

* 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.
* 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

Inclusion Criteria for randomized control study

* Patient age 20 years or older
* Abnormal cerebral perfusion by CTP or MRI
* 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.

Exclusion Criteria 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.

Where this trial is running

Taipei

• National Taiwan University Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Principal investigator: Hsien-Li Kao, MD — National Taiwan University Hospital
• Study coordinator: Hsien-Li Kao, MD

Conditions Carotid Occlusion