Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05723926
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-02
First Post:
2023-01-18
Brief Title:
Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation
Sponsor:
Javelin Medical
Organization:
Javelin Medical
Study Overview
Official Title:
Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INTERCEPT
Brief 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 eg within 12 months ischemic stroke vs only OAC
Detailed 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 eg within 12 months ischemic stroke These filters have been shown in vitro to capture all emboli 14 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 14 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None