Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation

Part of paid clinical trials in Rockford, Illinois.

Sponsor
Javelin Medical
Study ID
NCT05723926
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vine Filter — DEVICE
    The Vine filters are designed to be implanted in the common carotid arteries in order to capture emboli coming from the heart or great vessels, before they can enter the anterior intracranial circulation. The filter is deployed percutaneously using a 22G needle under ultrasound guidance.

Study Details

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.

Key Dates

Start date
Jan 9, 2026
Status verified
Jun 2026
Primary completion
Dec 20, 2028
Completion
Oct 20, 2030

Study Design

Enrollment
2,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Vine Filter and oral anticoagulant
    Participants randomized to the intervention will undergo implantation of bilateral carotid filters and OAC therapy. In addition, participants will receive additional single antiplatelet therapy with OAC for 6 months.
  • No Intervention: Usual Care (oral anticoagulant only)
    Participants randomized to control will not receive carotid filter implants but will receive usual care including OAC, throughout the course of the study.

Primary Outcome Measure

Large vessel occlusion strokes (efficacy) [ Time Frame: 44 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Mercyhealth Javon Bea Hospital - RiversideRockfordIllinois61114
Vibhav Bansal, Dr
[email protected]
8159715000
Vibhav Bansal, Dr (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medical CenterNew YorkNew York10065
Hooman Kamel, Dr
[email protected]
4158457543
Hooman Kamel, Dr (PRINCIPAL_INVESTIGATOR)
Erlanger Medical CenterChattanoogaTennessee37403
Cleopatra Thurman, Dr
[email protected]
423-778-3900
Cleopatra Thurman, Dr (PRINCIPAL_INVESTIGATOR)
Baptist Memorial Hospital-MemphisMemphisTennessee38120-
Methodist University HospitalMemphisTennessee38104-

Find similar trials in Rockford, IL

By condition
Atrial fibrillationStroke
By specialty
CardiologyHeart diseaseNeurologyBrain disorders
By research site
Mercyhealth Javon Bea Hospital - Riverside· Rockford, ILWeill Cornell Medical Center· New York, NYErlanger Medical Center· Chattanooga, TNBaptist Memorial Hospital-Memphis· Memphis, TNMethodist University Hospital· Memphis, TN

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