Endovascular Revascularization for Chronic Carotid Artery Occlusion Trial
- Conditions
- Carotid Occlusion
- Interventions
- Device: Endovascular revascularization
- Registration Number
- NCT03179774
- Lead Sponsor
- National Taiwan University Hospital
- Brief 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. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clinical registry-ER and OMT Endovascular revascularization In clinical registry setting, participants who selected Endovascular revascularization and optimal medical therapy as the treatment for carotid artery occlusion are enrolled. RCT-ER and OMT Endovascular revascularization In randomized control trial setting, participants who are randomized to received endovascular revascularization and optimal medical therapy for carotid artery occlusion are enrolled.
- Primary Outcome Measures
Name Time Method NCF improvement by Mini-Mental State Examination (MMSE) at 3 months and thereafter up to 12 months Neurocognitive function was evaluated by MMSE.
NCF improvement by verbal fluency test Color Trails Test Parts 1 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 at 3 months and thereafter up to 12 months Neurocognitive function was evaluated by Color Trails Test Parts 2
NCF improvement by verbal fluency test at 3 months and thereafter up to 12 months Neurocognitive function was evaluated verbal fluency test
NCF improvement by Alzheimer Disease Assessment Scale-Cognitive subscale (ADAS-Cog) at 3 months and thereafter up to 12 months Neurocognitive function was evaluated by ADAS-Cog
- Secondary Outcome Measures
Name Time Method Death and stroke within 30 days after the procedure and between 31 days and 1 year Cumulative incidence of death and ipsilateral stroke
Target vessel revascularization rate one year Target vessel revascularization rate
Procedure success rate 30 days 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.
Change of cerebral perfusion at 3 months and thereafter up to 12 months Change of cerebral perfusion measured by CT perfusion
Major stroke, ischemic stroke, or hemorrhagic stroke within 30 days after the procedure and between 31 days and 1 year Cumulative incidence of major stroke, ischemic stroke, or hemorrhagic stroke
Cambridge Neuropsychological Test Automated Battery (CANTAB) at 3 months and thereafter up to 12 months 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.
Technique success rate 30 days 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.
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Taipei, Taiwan