Carotid Implants for Stroke Prevention in Atrial Fibrillation

(INTERCEPT Trial)

Overseen By Sagit Broder, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Javelin Medical

Must be taking: Vitamin K antagonists, DOACs

Disqualifiers: Intracranial hemorrhage, Coagulation disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to prevent strokes in individuals with atrial fibrillation (AF) who have previously experienced a stroke. Researchers are testing whether a special implant called the Vine Filter, used alongside regular blood-thinning medication, can more effectively prevent strokes compared to the medication alone. The trial seeks participants with AF who have had a stroke within the past year and are currently on blood thinners or plan to use them. Meeting these criteria may make someone a suitable candidate for the study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance stroke prevention strategies.

What prior data suggests that the Vine Filter is safe for stroke prevention in atrial fibrillation patients?

Research has shown that the Vine™ filter, a device designed to prevent strokes, has undergone safety testing in both animals and humans. Initially tested in sheep, it was later evaluated in two human studies. The first study, CAPTURE 1, involved 25 participants and assessed the device's safety and tolerability. Participants in this study did not report any major safety issues.

Another study demonstrated that the Vine™ filter remained safe over approximately two years of follow-up. These studies provide strong evidence for ongoing research and suggest that the Vine™ filter is generally well-tolerated. This information is encouraging for those considering participation in clinical trials involving the Vine™ filter. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Vine Filter is unique because it offers a new approach to stroke prevention in patients with atrial fibrillation by using carotid implants. Unlike the standard care, which typically involves oral anticoagulants (OACs) alone, this treatment combines the benefits of OACs with bilateral carotid filters to potentially enhance protection against strokes. Researchers are excited about this treatment because it could provide an additional physical barrier to prevent clots from reaching the brain, offering a promising complement to existing medication-based strategies.

What evidence suggests that the Vine Filter is effective for stroke prevention in atrial fibrillation?

In this trial, participants will be randomized into two groups to evaluate the effectiveness of the Vine™ filter in preventing strokes in people with atrial fibrillation (AF). One group will receive the Vine™ filter implants along with oral anticoagulant (OAC) therapy and additional single antiplatelet therapy for 6 months. Research has shown that the Vine™ filter is a promising method for preventing strokes by catching large blood clots before they can cause harm. Specifically, studies have demonstrated that this filter can effectively catch blood clots larger than 1.4 mm, which often lead to major strokes. Early trials, such as the CAPTURE trial, showed success in preventing strokes in AF patients unable to take standard blood thinners. These findings suggest that the Vine™ filter could significantly reduce stroke risk in this high-risk group. Meanwhile, the control group will receive usual care with oral anticoagulant therapy only, without the carotid filter implants. ^{1 2 4 6 7}

Who Is on the Research Team?

Stuart Connolly, MD, FRCPC

Principal Investigator

Population Health Research Institute, McMaster University

Ashkan Shoamanesh, MD, FRCPC

Principal Investigator

Population Health Research Institute, McMaster University

Alexander P Benz, MD MSc

Principal Investigator

Population Health Research Institute

Vivek Y Reddy, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

Inclusion Criteria

I will be taking a blood thinner like warfarin or a DOAC during the trial.

Patient able to tolerate single antiplatelet therapy in addition to oral anticoagulation for 6 months, in the opinion of the investigator Inner common carotid artery diameter range: ≥5.3 mm and ≤8.8 mm

Accessibility: up to 40 mm from skin to common carotid artery center

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bilateral carotid filter implants and oral anticoagulation therapy, with additional single antiplatelet therapy for 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of large vessel occlusion strokes and ischemic strokes

68 months

What Are the Treatments Tested in This Trial?

Interventions

• Vine Filter

How Is the Trial Designed?

Group I: Vine Filter and oral anticoagulant Experimental Treatment 1 Intervention

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.

Group II: Usual Care (oral anticoagulant only) Active Control 1 Intervention

Participants randomized to control will not receive carotid filter implants but will receive usual care including OAC, throughout the course of the study.

Who Is Running the Clinical Trial?

Javelin Medical

Lead Sponsor

Trials

3

Recruited

2,100+

World Health Research Institute

Collaborator

Population Health Research Institute

Collaborator

Trials

165

Recruited

717,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7496024/

Permanent Bilateral Carotid Filters for Stroke Prevention in ...

A novel permanent carotid filter device for percutaneous implantation was developed for the purpose of stroke prevention.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03571789

Study Details | NCT03571789 | Carotid Artery Implant for ...

Vine™ is a permanent carotid filter designed to provide protection against embolic stroke in people with atrial fibrillation. It is implanted bilaterally in ...

3.

jacc.org

jacc.org/doi/10.1016/j.jacc.2019.04.035

Permanent Percutaneous Carotid Artery Filter to Prevent ...

A novel permanent coil filter directly placed into both common carotid arteries (CCAs) was designed to capture emboli >1.4 mm in diameter.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1553838920303146

Clinical A Permanent Common Carotid Filter for Stroke ...

A novel, permanent, bilateral, common carotid artery (CCA) coil filter implant was designed to capture stroke-producing emboli in atrial fibrillation patients.

5.

javelinmed.com

javelinmed.com/intercept-study

INTERCEPT Study

The purpose of the INTERCEPT trial is to assess the efficacy and safety of bilateral common carotid filter implantation with the Vine™ Embolic Protection System ...

6.

heartrhythmjournal.com

heartrhythmjournal.com/article/S1547-5271(21)00744-X/fulltext

B-PO01-061 STROKE PREVENTION IN ATRIAL ...

Percutaneous carotid coil placement for AF stroke prophylaxis was safe over ∼2 years follow up. These data provide the basis for future RCTs. Figure undfig1.

7.

clinicaltrial.be

clinicaltrial.be/en/details/64530?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Carotid Artery Implant for Preventing Stroke in Atrial Fi...

The Vine™ filter (Vine™ or implant) is a permanent carotid filter designed for stroke prevention in AF patients taking OAC at high stroke ...