Cognitive Impairment, Non-acute Carotid Artery Occlusion
Conditions
Keywords
Non-acute Carotid Artery Occlusion, Chronic Carotid Artery Occlusion, Symptomatic Carotid Artery Occlusion, Endovascular Recanalization, Balloon Guide Catheter, Cognitive Impairment
Brief summary
This study is a multicenter, prospective, randomized, open-label, blinded-endpoint clinical trial designed to evaluate the safety and potential efficacy of endovascular recanalization strategies in patients with symptomatic non-acute carotid artery occlusion and cognitive impairment. Eligible participants will be randomly assigned to best medical treatment alone, endovascular recanalization without proximal protection plus best medical treatment, or endovascular recanalization with proximal balloon protection plus best medical treatment. The study will assess whether endovascular recanalization improves cognitive function and whether proximal protection reduces procedure-related new ischemic lesions on diffusion-weighted magnetic resonance imaging.
Detailed description
Symptomatic non-acute carotid artery occlusion may lead to recurrent ischemic events, chronic cerebral hypoperfusion, and cognitive decline. Best medical treatment is the standard foundation of care, but selected patients with persistent hypoperfusion may remain at risk. Endovascular recanalization may improve cerebral perfusion, but procedure-related distal embolization and new ischemic lesions remain important safety concerns. Eligible patients will have symptomatic non-acute carotid artery occlusion, ipsilateral cerebral hypoperfusion, and baseline cognitive impairment defined by an education-adjusted Montreal Cognitive Assessment score of 25 or lower. Participants will be randomized in a 1:1:1 ratio to best medical treatment alone, endovascular recanalization without proximal protection plus best medical treatment, or endovascular recanalization with proximal balloon protection plus best medical treatment. In the proximal protection group, a balloon guide catheter will be used to achieve proximal flow arrest or flow control during key procedural steps. In the unprotected endovascular group, recanalization will be performed without routine proximal balloon flow control. The primary safety outcome is the number of new ischemic lesions on diffusion-weighted magnetic resonance imaging within 24 to 72 hours. The primary efficacy outcome is the change in Montreal Cognitive Assessment score from baseline to 6 months.
Interventions
OTHERGuideline-Based Best Medical Treatment
Guideline-based best medical treatment includes antiplatelet therapy and management of vascular risk factors, such as blood pressure, lipid, glucose, and lifestyle management, according to current clinical practice.
PROCEDUREEndovascular Recanalization With Proximal Balloon Protection
Endovascular recanalization will be performed using neurointerventional techniques. A balloon guide catheter will be positioned proximally to achieve temporary flow arrest or flow control during key lesion-treatment steps, with the aim of reducing distal migration of thrombus or plaque debris.
PROCEDUREEndovascular Recanalization Without Proximal Protection
Endovascular recanalization will be performed using standard neurointerventional techniques without routine proximal balloon flow arrest or flow control.
Sponsors
Dapeng Mo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. The age ranged from 18 to 80 years 2. Unilateral carotid artery occlusion confirmed by CTA or DSA (excluding anterior and middle cerebral artery occlusion) 3. Complete 3T-MRI within 1-3 days before operation 4. The time of carotid artery occlusion was more than 24h (confirmed by imaging or according to the patient's condition), and not more than 3 months 5. Ischemic stroke or TIA related to occluded vessels existed in the past 3 months, and the last ischemic event was \> 2 weeks; and there was cognitive impairment, MoCA score ≤ 25 after education correction 6. Imaging confirmed that there was hypoperfusion in the ipsilateral cerebral hemisphere of carotid artery occlusion, which met at least any of the following requirements: ①Head CT perfusion imaging showed low perfusion in the lesion vascular area (CBF decreased by 30% compared with contralateral perfusion) ②ASITN/SIR collateral circulation score based on DSA \< 3 points ③Cerebral infarction with hemodynamic abnormalities confirmed by head MRI (such as watershed infarction) 7. Sign the informed consent form
Exclusion criteria
1. There was severe neurological dysfunction (mRS ≥ 4) before enrollment 2. The ipsilateral common carotid artery was occluded, or the ipsilateral middle cerebral artery was severely stenosed or occluded 3. Non atherosclerotic occlusion (such as vasculitis, moyamoya disease, etc.) 4. Patients with massive cerebral infarction (infarction volume based on MRI-DWI/ADC is more than 70ml) 5. Untreated intracranial aneurysms, intracranial tumors (except meningiomas) or any intracranial vascular malformations 6. Evidence of cardiogenic embolism 7. Allergic to heparin, aspirin, clopidogrel, statins, metals, anesthetics, contrast agents, or unable to tolerate general anesthesia surgery 8. Any history of intracranial hemorrhage within 30 days (including cerebral parenchyma, ventricle, subarachnoid hemorrhage, subdural or epidural) 9. History of primary cerebral parenchymal hemorrhage 10. There are contraindications to antiplatelet drugs 11. There are coagulation disorders and systemic bleeding 12. Thrombocytopenia (\<100 × 10⁹/L) 13. Uncontrolled severe hypertension (systolic blood pressure\>180mmHg or diastolic blood pressure\>110mmHg) 14. Severe coronary heart disease, severe liver injury (AST or ALT more than 3 times the normal value), liver cirrhosis and severe renal insufficiency (creatinine\>177 μmol/L) were observed 15. Major surgical operations within 30 days or in the next 90 days 16. It is known that patients with dementia, cognitive impairment caused by other reasons or mental diseases cannot complete the assessment of neurological and cognitive functions 17. There are cerebral infarction that clearly involves the key brain areas of cognition, or there are neurological deficits that affect the accuracy of cognitive function assessment, such as severe aphasia, neglect, and audiovisual impairment. According to the judgment of the researchers, the decline of cognitive function is mainly caused by irreversible brain tissue injury 18. The expected survival time of patients with other diseases was less than 2 years 19. Pregnancy or lactation 20. Patients have been included in other studies, which is in conflict with this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of cognitive function (MoCA score) compared with baseline 6 months after randomization | 6 months after randomization | Changes of cognitive function (MoCA score) compared with baseline 6 months after randomization |
| Total number of new infarcts on DWI-MRI within 24-72 hours after randomization | Within 24-72h after randomization | Total number of new infarcts on DWI-MRI within 24-72 hours after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Restenosis or re-occlusion of target vessels confirmed by CTA/DSA 6 months after randomization | 6 months after randomization | Restenosis or re-occlusion of target vessels confirmed by CTA/DSA 6 months after randomization |
| The volume of new infarcts 24-72 hours after randomization | 24-72 hours after randomization | The volume of new infarcts 24-72 hours after randomization |
| Incidence of new infarcts 24-72 hours after randomization | 24-72 hours after randomization | Incidence of new infarcts 24-72 hours after randomization |
| Distribution characteristics of new infarcts 24-72 hours after randomization (within or beyond the scope of responsible vessels) | 24-72 hours after randomization | Distribution characteristics of new infarcts 24-72 hours after randomization (within or beyond the scope of responsible vessels) |
| location of new infarcts 24-72 hours after randomization (only cortical area, only deep white matter area, cortex and white matter were involved) | 24-72 hours after randomization | location of new infarcts 24-72 hours after randomization (only cortical area, only deep white matter area, cortex and white matter were involved) |
| The average number of new infarcts per enrolled patient 24-72 hours after randomization | 24-72 hours after randomization | The average number of new infarcts per enrolled patient 24-72 hours after randomization |
| The average number of new infarcts in the responsible vessels of each enrolled patient 24-72 hours after randomization | 24-72 hours after randomization | The average number of new infarcts in the responsible vessels of each enrolled patient 24-72 hours after randomization |
| The average number of new infarcts beyond the scope of responsible vessels per enrolled patient 24-72 hours after randomization | 24-72 hours after randomization | The average number of new infarcts beyond the scope of responsible vessels per enrolled patient 24-72 hours after randomization |
| The rate of symptomatic intracranial hemorrhage (SICH) within 72 hours after randomization (Heidelberg bleeding classification) | Within 72 hours after randomization | The rate of symptomatic intracranial hemorrhage (SICH) within 72 hours after randomization (Heidelberg bleeding classification) |
| Operation related complications within 72 hours after randomization (operation related complications, defined as arterial dissection, new area embolism, cavernous sinus fistula, arterial perforation, subarachnoid hemorrhage, etc.) | Within 72 hours after randomization | Operation related complications within 72 hours after randomization (operation related complications, defined as arterial dissection, new area embolism, cavernous sinus fistula, arterial perforation, subarachnoid hemorrhage, etc.) |
| Any stroke (hemorrhagic or ischemic) or death within 30 days after randomization | Within 30 days after randomization | Any stroke (hemorrhagic or ischemic) or death within 30 days after randomization |
| Occurrence of recurrent ischemic stroke (symptomatic ischemic cerebral infarction or TIA) of responsible vessels within 6 months after randomization | Within 6 months after randomization | Occurrence of recurrent ischemic stroke (symptomatic ischemic cerebral infarction or TIA) of responsible vessels within 6 months after randomization |
| The changes of cognitive function (MMSE score) compared with baseline 6 months after randomization | 6 months after randomization | The changes of cognitive function (MMSE score) compared with baseline 6 months after randomization |
| Changes in fundus blood vessels and fundus structures 6 months after randomization (average thickness of retinal nerve fiber layer around optic disc and average thickness of macular ganglion cell complex/ganglion cell-inner plexus layer | 6 months after randomization | Changes in fundus blood vessels and fundus structures 6 months after randomization (average thickness of retinal nerve fiber layer around optic disc and average thickness of macular ganglion cell complex/ganglion cell-inner plexus layer |
| mRS score 6 months after randomization | 6 months after randomization | mRS score 6 months after randomization |
Countries
China
Contacts
CONTACTDapeng Mo, MD
PRINCIPAL_INVESTIGATORDapeng Mo, MD
Beijing Tiantan Hospita
Outcome results
None listed