Endovascular Revascularization for Chronic Carotid Artery Occlusion Trial

ConditionCarotid Occlusion

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age20+

SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Endovascular revascularization
Device
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.

Treatment groups

200 Participants

are divided into 4 treatment groups

Group A: Clinical registry-ER and OMTExperimental treatment 1 intervention

Group B: Clinical registry-OMTNo intervention 0 interventions

Group C: RCT-ER and OMTExperimental treatment 1 intervention

Group D: RCT-OMTNo intervention 0 interventions

Trial outcomes

Primary outcomes

NCF improvement by Alzheimer Disease Assessment Scale-Cognitive subscale (ADAS-Cog)

Neurocognitive function was evaluated by ADAS-Cog

Time frame

at 3 months and thereafter up to 12 months

NCF improvement by Mini-Mental State Examination (MMSE)

Neurocognitive function was evaluated by MMSE.

Time frame

at 3 months and thereafter up to 12 months

NCF improvement by verbal fluency test

Neurocognitive function was evaluated verbal fluency test

Time frame

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

Time frame

at 3 months and thereafter up to 12 months

Secondary outcomes

Death and stroke

Cumulative incidence of death and ipsilateral stroke

Time frame

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

Time frame

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.

Time frame

at 3 months and thereafter up to 12 months

Change of cerebral perfusion

Change of cerebral perfusion measured by CT perfusion

Time frame

at 3 months and thereafter up to 12 months

Other outcomes

Major procedure complication

Major procedure complication includes intracranial hemorrhage, myocardial infarction, embolic stroke, vascular complication and death during endovascular revascularization or within 30 days after endovascular revascularization.

Time frame

30 days

Bleeding complication

any bleeding events during the study

Time frame

one year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

Source ClinicalTrials.gov

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