Endovascular Treatment for Symptomatic Non-acute Carotid Occlusion
- Sponsor
- Dapeng Mo
- Study ID
- NCT07803419
- Status
- Not Yet Recruiting
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Conditions
- Cognitive Impairment
- Non-acute Carotid Artery Occlusion
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Guideline-Based Best Medical Treatment — OTHERGuideline-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 — PROCEDUREEndovascular 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 — PROCEDUREEndovascular recanalization will be performed using standard neurointerventional techniques without routine proximal balloon flow arrest or flow control.
Study Details
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.
Key Dates
- First listed
- Sep 3, 2026
- Start date
- Sep 1, 2026
- Status verified
- Aug 2026
- Primary completion
- Jun 1, 2028
- Completion
- Dec 1, 2028
Study Design
- Enrollment
- 180 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Best Medical TreatmentParticipants in this arm will receive guideline-based best medical treatment, including antiplatelet therapy and management of vascular risk factors.
- Experimental: Endovascular Recanalization With Proximal Balloon Protection Plus Best Medical TreatmentParticipants 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.
- Experimental: Endovascular Recanalization Without Proximal Protection Plus Best Medical TreatmentParticipants in this arm will undergo endovascular recanalization without routine proximal balloon flow control, in addition to guideline-based best medical treatment.
Primary Outcome Measure
Changes of cognitive function (MoCA score) compared with baseline 6 months after randomization [ Time Frame: 6 months after randomization ]
Central Contacts
- Dapeng Mo, MD18811039300
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