Now Enrolling:

INTERCEPT Global Pivotal Trial
Targeting Recurrent Stroke Risk in Atrial Fibrillation Patients

INTERCEPT is a global trial evaluating the Vine™ permanent carotid filter as an adjunct to oral anticoagulation

When Anticoagulation Isn’t Enough

Atrial Fibrillation (AF) is the most common sustained cardiac arrhythmia and a major cause of cardioembolic ischemic stroke, often from large emboli leading to large vessel occlusion (LVO).

Although long-term oral anticoagulation (OAC), including direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs), is effective, it does not completely eliminate stroke risk. Patients who experience ischemic stroke before OAC treatment have a 5-year ~20% cumulative risk of recurrent ischemic stroke, whereas those with breakthrough stroke while treated with OAC have a 5-year cumulative risk of ~25%. Approximately 90% of these strokes occur in the anterior circulation.

1. Benz AP, Eikelboom JW, Hohnloser SH, et al. Outcomes of patients with atrial fibrillation and ischaemic stroke despite receiving oral anticoagulation. Presented at European Stroke Organisation Conference (ESOC) 2022.
2. Seiffge DJ, De Marchis GM, Koga M, et al. Ischemic Stroke despite Oral Anticoagulant Therapy in Patients with Atrial Fibrillation. Ann Neurol. 2020; 87:677-687.
3. Tanaka K, Koga M, Lee KJ, et al. Atrial Fibrillation-Associated Ischemic Stroke Patients With Prior Anticoagulation Have Higher Risk for Recurrent Stroke. Stroke. 2020; 51:1150-1157.
4. Diener HC, Connolly SJ, Ezekowitz MD, et al. Dabigatran compared with warfarin in patients with atrial fibrillation and previous transient ischaemic attack or stroke: a subgroup analysis of the RE-LY trial. Lancet Neurol. 2010; 9:1157-1163.
5. Easton JD, Lopes RD, Bahit MC, et al. Apixaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of the ARISTOTLE trial. Lancet Neurol. 2012; 11:503-511.
6. Hankey GJ, Patel MR, Stevens SR, et al. Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF. Lancet Neurol. 2012; 11:315-322.
7. Rost NS, Giugliano RP, Ruff CT, et al. Outcomes With Edoxaban Versus Warfarin in Patients With Previous Cerebrovascular Events: Findings From ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48). Stroke. 2016; 47:2075-2082.

Can Adjunctive Permanent Embolic Protection Filters Enhance Stroke Prevention in AF Patients on Oral Anticoagulation?

Introducing the Vine™ Permanent Embolic Protection Filter

The Vine™ Filter is a permanent, bilateral common carotid artery (CCA) implant made from a single nitinol wire and designed to capture emboli ≥1.4 mm before they can reach the anterior cerebral circulation.

The INTERCEPT Study

INTERCEPT is a global, prospective, randomized, open-label, blinded-endpoint (PROBE) study, including AF patients with a history of ischemic stroke within the past year. The study is designed to evaluate whether placement of the Vine™ Filter in the CCAs in addition to OAC, as compared to OAC alone, can reduce (i) anterior circulation strokes due to large vessel occlusion (LVO) and (ii) total ischemic stroke.

The study is currently enrolling patients worldwide.

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Led By Global Stroke Research Experts

Dr. Ashkan Shoamanesh

Co-Principal Investigator Neurology WHRI, McMaster University, Hamilton, Canada

Dr. Alexander Benz

Co-Principal Investigator Cardiology WHRI, McMaster University, Hamilton, Canada

Dr. P.J. Devereaux

Trial Chair Cardiology WHRI, McMaster University, Hamilton, Canada

Watch INTERCEPT trial leaders Dr. Shoamanesh, Dr. Benz and Dr. Devereaux discussing the clinical need and introducing the INTERCEPT trial

Interview Transcript: Dr. Shoamanesh, Dr. Benz and Dr. Devereaux

When I first heard about this six or seven years ago, I thought, “Wow, this is radical.”

It’s a bit crazy, for lack of a better word.

Wow, like how come no one has thought about this before?

When you think about all the medical conditions that we treat, and I say this as a cardiologist, there is no ambiguity in my mind.

One of the most devastating things, way past most cardiovascular issues, is actually stroke.

People’s loss of function, their inability to communicate, inability to take care of themselves, potential cognitive decline — this is something that scares everyone.

By the year 2050, we think the burden of AF is going to increase by 60%, and with it there’ll be a large increase in AF-related strokes, and the impact that it’ll have on our healthcare systems will be grave.

Anticoagulants are a two-edged sword in that they do have a great treatment effect in reducing stroke in patients with AF, but if you try to escalate their potency, you have offsetting bleeding that offsets the benefit that they provide.

So, patients with atrial fibrillation who suffer a stroke despite taking a blood thinner — currently we do not have, you know, an effective treatment to prevent another stroke from happening in these patients.

For certain, I was in the group of most clinicians who were very focused on anticoagulation drug therapy to tackle this problem.

And then when someone says something that is very novel, that had not occurred to you, why hadn’t anyone thought of this?

And it was just a real moment of, “That is very intriguing. This is something that deserves further exploration.”

The VINE device has had an interesting journey, right? Let’s put carotid filters into patients to prevent stroke.

And I think what started with a pretty simple idea has evolved dramatically over the last 10 years.

It’s kind of like a seed that grows in your mind, and that when you first hear about it, it seems like a pretty radical new approach.

The fact that we only saw one LVO stroke in 300 patient-years of follow-up across CAPTURE 1 and CAPTURE 2 is absolutely remarkable.

So, INTERCEPT is one of the largest device trials for stroke reduction.

So, I expect if this trial is positive, we’ll establish a new paradigm that will totally alter and improve outcomes.

First, for the patients where there’s currently no good alternative for this large unmet need that we discussed earlier, there is a massive potential benefit that they could get as being part of the study.

So, having their patients enter the INTERCEPT Study allows them to have access to a device that could provide benefit that would not otherwise be eligible for them.

And historically, or even at present, we often outsource certain procedures like percutaneous left atrial appendage occlusion to other specialties like cardiology, whereas the VINE Filter System allows us to actually keep that within the neurosciences, expand our own divisions and departments for the betterment of our patients and for the expansion and development of our field.

I think participating in INTERCEPT is great in that you are contributing to a meaningful research endeavor, and you may be able to be part of the solution for stroke prevention in very high-risk patients.

Most people who have joined our efforts were hesitant at first.

But I would say, allow us to have a conversation with you. Invite us to have a talk with your group where we go through the data, answer all your questions before you make up your mind.

You could be part of history, frankly, by participating in this study and helping, working together with our global network, and trying to prove the efficacy of this device through successful completion of INTERCEPT.

So, I run a consortium in Canada that is focused on improving the ecosystem for doing clinical trials.

So, one of our patient partners, she showed a picture of her son at the age of two who had been diagnosed with cancer.

And both her and her husband were given the most unimaginable news that their child was going to die, that there was no treatment for their child.

This woman, who was a real force of nature, rejected this position. She did her own research online.

And she eventually found a place that was doing a novel clinical trial in this cancer that her son had.

They would end up relocating to bring their son to this location where this trial was happening and enrolling their child in this trial.

And the next picture she would show is of her son, 17 years of age and healthy.

The wonderful part of the story and the message is: at times, clinical trials save lives, even when you’re told there is no hope.

That doesn’t happen every day, but it does happen.

Watch INTERCEPT trial national leaders Dr. David Seiffge (Switzerland) and Dr. Jaime Masjuan (Spain) introducing the clinical need, the Vine™ Filter and the INTERCEPT trial

Interview Transcript: Dr. David Seiffge and Dr. Jaime Masjuan

One or two percent of all atrial fibrillation patients will have a stroke every year. These strokes are often large-vessel occlusion strokes, with large clots coming from the heart and blocking arteries in the brain, causing devastating strokes.

Each day or each week in our hospital, we have patients who have had a breakthrough stroke while being anticoagulated. Patients and families ask themselves, “What did we do wrong?” because they followed the best medical therapy, but despite following our recommendations, these patients still have a stroke. That is devastating for them, also on a psychological level.

We cannot offer them much more than changing the anticoagulant, and that has not been demonstrated to be useful.

Honestly, at the moment, we don’t have an answer for those patients.

The VINE Filter is a completely new approach to protecting the brain from cardiac emboli caused by atrial fibrillation.

We have now completed two clinical trials with the VINE device in humans, in patients with atrial fibrillation.

CAPTURE was the first clinical trial with this device, and it included patients with atrial fibrillation who were unsuitable for anticoagulation.

In CAPTURE 2, it was mandatory that patients were able to receive anticoagulation.

The VINE approach tries to combine two complementary approaches. On the one hand, patients remain on oral anticoagulation to prevent clot formation in the heart. On the other hand, the VINE Filter protects the brain by shielding the anterior circulation against any clot arising from the heart that could endanger the brain.

The VINE device can offer us a safe procedure. In my experience, it has been demonstrated to be safe, and implantation is straightforward.

The thing that surprised us was how easy it was. There were no complications.

When I first heard about the VINE Filter, I shared the concerns about direct carotid artery puncture. That was our feeling before treating our first patient.

But now that fear has disappeared completely because, in our 11 patients, there were no safety concerns and no bleeding in the neck.

The patient does not feel anything. It really is a very safe technique. It is easy, it does not take very long, and the procedure lasts only about 15 minutes on each side.

Hopefully, it can be effective in the prevention of stroke.

Before receiving the VINE device, patients are usually very afraid of having another stroke. They are very happy that the medical team can offer them a new alternative.

The INTERCEPT Study is a pivotal Phase III trial that will compare the combined use of the VINE Filter together with oral anticoagulation therapy against the standard of care: anticoagulation therapy alone.

The majority of our patients who were included in the CAPTURE 2 trial were selected during hospitalization for stroke in our stroke unit.

This gives them the expectation that there may be something else we can do to help prevent another stroke.

In this type of trial, it is very important to have a multidisciplinary team, with a cardiologist and a vascular surgeon or neuroradiologist who will perform the procedure. Everything is prepared for the patient.

Your patient with atrial fibrillation has just had a stroke, and you are considering what to do next to protect that patient from a recurrent stroke.

Participating in the INTERCEPT Study is a major opportunity to help these patients reduce the burden of stroke and have a better life.

When I speak with my colleagues in Spain, I tell them to be confident with the technique.

You need an experienced professional who is capable of implanting the device. If you complete the short training on how to perform the procedure and follow the protocol, I believe there should be no significant safety concerns.

I think you will have a big surprise during follow-up when you see how these patients may benefit from this device.

That is how I encourage my colleagues to participate in this trial.

Global Excellence Centers

The INTERCEPT study is led by internationally recognized experts, bringing deep clinical expertise to this next-generation approach to stroke prevention.

Dr. Brian Van Adel

Interventional Neuroradiology

Hamilton Health Sciences, McMaster University, Canada

In our first experience implanting the Vine carotid filter, what immediately stood out was how simple and efficient the procedure was. Deployment through a small needle under ultrasound guidance was technically straightforward and completed within minutes. Despite this being our first case with the technology, the workflow felt intuitive and the learning curve was minimal. The device represents a truly novel approach to stroke prevention.

Dr. Hooman Kamel

Department of Neurology

Weill Cornell Medicine, New York, USA

We are so excited to help launch the INTERCEPT trial in the US. This was our first enrolled patient and first implant, but with great collaboration between the sponsor team, coordinating center, research coordinators, and neurosurgery team. Everything went smoothly and our patient is doing very well at home. We look forward to continued collaboration as we help advance the trial toward completion and, hopefully, a successful outcome.

Prof. Dr. Med. Jaime Masjuan Vallejo

Head of Neurology Department

Hospital Universitario Ramón y Cajal, Spain

Cardioembolic breakthrough strokes are a serious problem we face every day. The possibility of having a physical mechanism like carotid filters that could prevent emboli from reaching the brain is truly exciting.

News Highlights

Hamilton Health Sciences Operator First Experience with The Vine™ Procedure. Dr. Brian Van Adel, Interventional Neuroradiologist, Shares His Experience With Vine™ Procedure; ESOC

May2026

Hamilton Health Sciences Enrolls First INTERCEPT Trial Patient in Canada

May 2026

Dr. PJ Devereaux, INTERCEPT Trial Chair, Discussing the Importance of Clinical Trials And Their Role in Expanding Treatment Opportunities For Patients; ESOC

May 2026

First U.S Patient Enrolled in INTERCEPT Trial, Rockford, Illinois

May 2026

Explore the Future of Comprehensive Stroke Prevention

Investigational device, limited by United States law to investigational use.

This medical device is for investigational use only and is not yet approved for commercial sale.