Clinical Trials Logo

Clinical Trial Summary

Patients with atrial fibrillation (AF) who have had a prior stroke are at very high risk of recurrent ischemic stroke. About 40% of these strokes are due to large emboli which result in large cerebral vessel occlusion (LVO). This randomized control trial aims to address this unmet need by testing whether use of bilateral carotid filter implants in addition to OAC will reduce the risk of stroke in AF patients with recent (e.g. within 12 months) ischemic stroke vs. only OAC.


Clinical Trial Description

Patients with atrial fibrillation (AF) who have had a prior stroke are at very high risk of recurrent ischemic stroke. Oral anticoagulation (OAC) is very effective for stroke reduction, but despite this treatment, AF patients with stroke in the past year still have a very high risk of recurrent stroke which is often disabling; estimated to be between 3 and 7% per year. About 40% of these strokes are due to large emboli which result in large cerebral vessel occlusion (LVO). Thus, there is a well-documented unmet medical need to improve stroke reduction therapy for AF patients with prior ischemic stroke. This study aims to address this unmet need by testing whether use of bilateral carotid filter implants in addition to OAC will reduce the risk of stroke in AF patients with recent (e.g. within 12 months) ischemic stroke. These filters have been shown, in vitro, to capture all emboli ≥1.4 mm in length or diameter and additionally to capture some emboli of smaller diameter. Once placed bilaterally in the common carotid arteries, they are expected to prevent most emboli ≥1.4 mm in length or diameter and potentially some smaller ones from reaching the anterior cerebral circulation. Although the posterior circulation will not be protected, the majority of all large ischemic strokes in patients with AF occur in the anterior circulation (about 90%). It is hypothesized therefore that bilateral carotid implants will greatly reduce embolic strokes due to LVO (60% reduction) and will have an important but smaller effect on embolic strokes due to smaller emboli which cause non-LVO occlusion (10% reduction). LVO-associated strokes are more often large and disabling compared to non-LVO strokes. The primary goal of the study is to show that bilateral carotid implants reduce strokes due to LVO and that there is also a reduction in total ischemic stroke, both in comparison to a control arm (treatment with OAC only). The study will also evaluate the safety of the intervention. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05723926
Study type Interventional
Source Javelin Medical
Contact Sagit broder, MSc
Phone +972587112116
Email sagit@javelinmed.com
Status Not yet recruiting
Phase N/A
Start date January 20, 2025
Completion date October 20, 2030

See also
  Status Clinical Trial Phase
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Recruiting NCT03869138 - Alternative Therapies for Improving Physical Function in Individuals With Stroke N/A
Completed NCT04034069 - Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial N/A
Completed NCT04101695 - Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects N/A
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Completed NCT00391378 - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS) N/A
Recruiting NCT06204744 - Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial N/A
Active, not recruiting NCT06043167 - Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
Active, not recruiting NCT04535479 - Dry Needling for Spasticity in Stroke N/A
Completed NCT03985761 - Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke N/A
Recruiting NCT00859885 - International PFO Consortium N/A
Recruiting NCT06034119 - Effects of Voluntary Adjustments During Walking in Participants Post-stroke N/A
Completed NCT03622411 - Tablet-based Aphasia Therapy in the Chronic Phase N/A
Completed NCT01662960 - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke N/A
Recruiting NCT05854485 - Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke N/A
Active, not recruiting NCT05520528 - Impact of Group Participation on Adults With Aphasia N/A
Completed NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT05805748 - Serious Game Therapy in Neglect Patients N/A
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Recruiting NCT05993221 - Deconstructing Post Stroke Hemiparesis