INTERCEPT Version 1.0
Research type
Research Study
Full title
Carotid Implants for Prevention of Stroke Recurrence from Large Vessel Occlusion in Atrial Fibrillation Patients Treated with Oral Anticoagulation.
IRAS ID
372083
Contact name
Sagit Broder
Contact email
Sponsor organisation
Javelin Medical Ltd.
Clinicaltrials.gov Identifier
Duration of Study in the UK
8 years, 0 months, 1 days
Research summary
People with atrial fibrillation, which is a common heart rhythm problem, have a higher risk of stroke. Even when taking blood-thinning medicines (oral anticoagulants), those who have already had a stroke remain at risk of another one. Many of these strokes are caused by large blood clots blocking major brain arteries, which often lead to severe disability.
The INTERCEPT Trial is being performed to test whether a new type of medical device, called the Vine™ Embolic Protection System (also known as filters), can reduce the risk of stroke by preventing these large blood clots from reaching the brain.
One filter is placed in each of the two main neck arteries (called the common carotid arteries). The filters are designed to prevent blood clots, that are big enough to cause major strokes, from reaching the brain. The filters will be implanted permanently using a minimally invasive ultrasound-guided procedure.
The trial will include adults with atrial fibrillation who have had an ischaemic stroke (a stroke caused by a blood clot) within the past year, and who are already planned to stay on blood-thinning medicines. Participants will be randomly chosen to either receive the filters or not. All participants will be followed for up to 8 years to see if the filters reduce the risk of another stroke, to check for any side effects, and to complete questionnaires relating to their stroke symptoms, daily activities, and physical functions.
The study is funded by the sponsor, Javelin Medical ltd. In the UK, the study will will take place in NHS hospitals with experience in stroke care. Overall, the study will take place in up to 20 countries.
If successful, this medical device could offer extra protection against disabling strokes for people at high risk of another stroke.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
26/YH/0106
Date of REC Opinion
18 Jun 2026
REC opinion
Favourable Opinion