NCT03571789Completed
Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients
Source: ClinicalTrials.gov · Last updated 20 Feb 2025
Brief summary (registry, in English)
Vine™ is a permanent carotid filter designed to provide protection against embolic stroke in people with atrial fibrillation. It is implanted bilaterally in the common carotid arteries from a thin needle under ultrasound guidance. The procedure is performed without general anesthesia and takes minutes. The safety, feasibility and tolerability of Vine™ will be evaluated. Patients who are eligible will receive Vine™ and will be followed-up for a year after device implantation.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 30 May 2018
- Start date
- 12 Sept 2017
- Primary completion date
- 13 Dec 2018
- Lead sponsor
- Javelin Medical
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT03571789
What you commit to
- Study type: Interventional
- Participants enrolled: 25
- From 12 Sept 2017 to the primary completion date, 13 Dec 2018
- 4 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent stroke, TIA, or myocardial infarction (MI) within two months prior to index procedure
- Any planned surgical or endovascular procedure within 14 days prior to or 30 days after the index procedure
- Active participation in another investigational drug or device treatment study
Other illness
- Evidence of any atherosclerotic disease in CCA above the clavicles
- Contraindicated or allergic to antiplatelet therapy, or any medication required during the study
- Active systemic infection
- Known hereditary or acquired coagulation disorders
- A co-morbid disease or condition that could confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments
- Current use or a recent history of illicit drug(s) use or alcohol abuse (defined as regular or daily consumption of more than four alcoholic drinks per day)
- Any other condition that in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study
Other
- Evidence of carotid stenosis \> 30% \[CCA, internal carotid artery (ICA), or external carotid artery (ECA)
- Evidence of carotid dissection
- Pre-existing stent(s) in CCA
- Female who is pregnant or who is planning to become pregnant during the course of the study
- Life expectancy of less than 1 year
- Known sensitivity to nickel or titanium metals, or their alloys
Who the study is looking for
- Atrial fibrillation (AF): documented persistent or permanent
- CHA2DS2-VASc score ≥ 4
- Age \> 50
- Unsuitable for oral anticoagulation therapy (OAC), defined as contraindicated for OAC, patient refusing OAC, or physician is reluctant to prescribe OAC
- Maximal (systolic) CCA diameter range: ≥ 5.3mm and ≤ 9.8mm
- CCA accessibility: up to 60mm from skin to CCA center, safe approach
- Patient is willing to provide informed consent
- Patient is willing to complete all scheduled follow-up
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| OLV Ziekenhuis Coordinator of this site? Confirm its status | Aalst | Belgium | Unknown status |
| ZNA Stuivenberg Coordinator of this site? Confirm its status | Antwerp | Belgium | Unknown status |
| Na Homolce Hospital Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Sint Antonius Ziekenhuis Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.