Carotid Occlusion Clinical Trial
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.
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.
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