Endovascular Treatment for Symptomatic Non-acute Carotid Occlusion

NCT07803419 | Not Yet Recruiting DMC

• 1 other identifier: HX-A-2026054
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-acute Carotid Artery Occlusion; Cognitive Impairment

Keywords

Non-acute Carotid Artery Occlusion; Chronic Carotid Artery Occlusion; Symptomatic Carotid Artery Occlusion; Endovascular Recanalization; Balloon Guide Catheter; Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• 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

  6 months after randomization

• 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

  Within 24-72h after randomization

Secondary Outcomes (15)

• The volume of new infarcts 24-72 hours after randomization

  24-72 hours after randomization

• Incidence of new infarcts 24-72 hours after randomization

  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

• 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

• The average number of new infarcts per enrolled patient 24-72 hours after randomization

  24-72 hours after randomization

Other Outcomes (5)

• Occurrence of recurrent ischemic stroke (symptomatic ischemic cerebral infarction or TIA) of responsible vessels within 12 months after randomization

  Within 12 months after randomization

• Restenosis or reocclusion of target vessels confirmed by CTA/DSA 12 months after randomization

  12 months after randomization

• The MMSE score changes compared with baseline 12 months after randomization

  12 months after randomization

Study Arms (3)

Best Medical Treatment

ACTIVE COMPARATOR

Participants in this arm will receive guideline-based best medical treatment, including antiplatelet therapy and management of vascular risk factors.

Other: Guideline-Based Best Medical Treatment

Endovascular Recanalization With Proximal Balloon Protection Plus Best Medical Treatment

EXPERIMENTAL

Participants in this arm will undergo endovascular recanalization with proximal balloon protection in addition to guideline-based best medical treatment. Proximal balloon protection will be used to achieve temporary proximal flow arrest or flow control during key procedural steps.

Procedure: Endovascular Recanalization With Proximal Balloon Protection

Endovascular Recanalization Without Proximal Protection Plus Best Medical Treatment

EXPERIMENTAL

Participants in this arm will undergo endovascular recanalization without routine proximal balloon flow control, in addition to guideline-based best medical treatment.

Procedure: Endovascular Recanalization Without Proximal Protection

Interventions

Guideline-Based Best Medical Treatment OTHER

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.

Best Medical Treatment

Endovascular Recanalization With Proximal Balloon Protection PROCEDURE

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.

Endovascular Recanalization With Proximal Balloon Protection Plus Best Medical Treatment

Endovascular Recanalization Without Proximal Protection PROCEDURE

Endovascular recanalization will be performed using standard neurointerventional techniques without routine proximal balloon flow arrest or flow control.

Endovascular Recanalization Without Proximal Protection Plus Best Medical Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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)
• Sign the informed consent form

You may not qualify if:

• 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)
• Untreated intracranial aneurysms, intracranial tumors (except meningiomas) or any intracranial vascular malformations
• Evidence of cardiogenic embolism
• Allergic to heparin, aspirin, clopidogrel, statins, metals, anesthetics, contrast agents, or unable to tolerate general anesthesia surgery
• Any history of intracranial hemorrhage within 30 days (including cerebral parenchyma, ventricle, subarachnoid hemorrhage, subdural or epidural)
• History of primary cerebral parenchymal hemorrhage
• There are contraindications to antiplatelet drugs
• There are coagulation disorders and systemic bleeding
• Thrombocytopenia (\<100 × 10⁹/L)
• Uncontrolled severe hypertension (systolic blood pressure\>180mmHg or diastolic blood pressure\>110mmHg)
• 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
• Major surgical operations within 30 days or in the next 90 days

Sponsors & Collaborators

• Dapeng Mo: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100010, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Dapeng Mo, MD

  Beijing Tiantan Hospita

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dapeng Mo, MD

CONTACT

18811039300; bjttmodp@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice-Director of Interventional Neuroradiology, Department of Neurology

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)