Endovascular Treatment for Symptomatic Non-acute Carotid Occlusion
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorDapeng Mo
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The age ranged from 18 to 80 years
Unilateral carotid artery occlusion confirmed by CTA or DSA (excluding anterior and middle cerebral artery occlusion)
Complete 3T-MRI within 1-3 days before operation
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
Disqualifiers
There was severe neurological dysfunction (mRS ≥ 4) before enrollment
The ipsilateral common carotid artery was occluded, or the ipsilateral middle cerebral artery was severely stenosed or occluded
Non atherosclerotic occlusion (such as vasculitis, moyamoya disease, etc.)
Patients with massive cerebral infarction (infarction volume based on MRI-DWI/ADC is more than 70ml)
Trial design
Design model
Parallel
Treatments tested in this trial
Guideline-Based Best Medical Treatment
Other interventionGuideline-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.
Endovascular Recanalization With Proximal Balloon Protection
Procedure/SurgeryEndovascular 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.
Endovascular Recanalization Without Proximal Protection
Procedure/SurgeryEndovascular recanalization will be performed using standard neurointerventional techniques without routine proximal balloon flow arrest or flow control.
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: Best Medical TreatmentActive comparator 1 intervention
Group B: Endovascular Recanalization With Proximal Balloon Protection Plus Best Medical TreatmentExperimental treatment 1 intervention
Group C: Endovascular Recanalization Without Proximal Protection Plus Best Medical TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes of cognitive function (MoCA score) compared with baseline 6 months after randomization
Changes of cognitive function (MoCA score) compared with baseline 6 months after randomization
Time frame
6 months after randomization2
Total number of new infarcts on DWI-MRI within 24-72 hours after randomization
Total number of new infarcts on DWI-MRI within 24-72 hours after randomization
Time frame
Within 24-72h after randomizationSecondary outcomes
1
The volume of new infarcts 24-72 hours after randomization
The volume of new infarcts 24-72 hours after randomization
Time frame
24-72 hours after randomization2
Incidence of new infarcts 24-72 hours after randomization
Incidence of new infarcts 24-72 hours after randomization
Time frame
24-72 hours after randomization3
Distribution characteristics of new infarcts 24-72 hours after randomization (within or beyond the scope of responsible vessels)
Distribution characteristics of new infarcts 24-72 hours after randomization (within or beyond the scope of responsible vessels)
Time frame
24-72 hours after randomization4
location of new infarcts 24-72 hours after randomization (only cortical area, only deep white matter area, cortex and white matter were involved)
location of new infarcts 24-72 hours after randomization (only cortical area, only deep white matter area, cortex and white matter were involved)
Time frame
24-72 hours after randomizationOther outcomes
1
Occurrence of recurrent ischemic stroke (symptomatic ischemic cerebral infarction or TIA) of responsible vessels within 12 months after randomization
Occurrence of recurrent ischemic stroke (symptomatic ischemic cerebral infarction or TIA) of responsible vessels within 12 months after randomization
Time frame
Within 12 months after randomization2
Restenosis or reocclusion of target vessels confirmed by CTA/DSA 12 months after randomization
Restenosis or reocclusion of target vessels confirmed by CTA/DSA 12 months after randomization
Time frame
12 months after randomization3
The MMSE score changes compared with baseline 12 months after randomization
The MMSE score changes compared with baseline 12 months after randomization
Time frame
12 months after randomization4
MoCA score changes compared with baseline 12 months after randomization
MoCA score changes compared with baseline 12 months after randomization
Time frame
12 months after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dapeng Mo
Lead sponsor
Beijing Tiantan Hospital
Sponsor institution
Source ClinicalTrials.gov
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