Clinical trial NCT03571789: Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients
Official title: Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: AF
Lead sponsor: Javelin Medical
Sponsor class: INDUSTRY
First posted: 2018-06-28
Enrollment: 25
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multicenter, prospective, non-randomized, open-label, first-in-human (FIH) study
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: CAPTURE is a prospective, single-arm, multicenter trial, designed to evaluate the safety, feasibility and tolerability of the Vine™ permanent carotid filter. The trial will enroll up to 30 patients, and will be conducted in up to five sites worldwide. All enrolled patients will be invited for non-invasive follow-up tests and clinical evaluations according to the study protocol.

Eligibility criteria: Inclusion Criteria:

1. Atrial fibrillation (AF): documented persistent or permanent
2. CHA2DS2-VASc score ≥ 4
3. Age \> 50
4. Unsuitable for oral anticoagulation therapy (OAC), defined as contraindicated for OAC, patient refusing OAC, or physician is reluctant to prescribe OAC
5. Maximal (systolic) CCA diameter range: ≥ 5.3mm and ≤ 9.8mm
6. CCA accessibility: up to 60mm from skin to CCA center, safe approach
7. Patient is willing to provide informed consent
8. Patient is willing to complete all scheduled follow-up

Exclusion Criteria:

1. Evidence of carotid stenosis \> 30% \[CCA, internal carotid artery (ICA), or external carotid artery (ECA)
2. Evidence of any atherosclerotic disease in CCA above the clavicles
3. Evidence of carotid dissection
4. Pre-existing stent(s) in CCA
5. Contraindicated or allergic to antiplatelet therapy, or any medication required during the study
6. Recent stroke, TIA, or myocardial infarction (MI) within two months prior to index procedure
7. Female who is pregnant or who is planning to become pregnant during the course of the study
8. Life expectancy of less than 1 year
9. Active systemic infection
10. Known sensitivity to nickel or titanium metals, or their alloys
11. Known hereditary or acquired coagulation disorders
12. Any planned surgical or endovascular procedure within 14 days prior to or 30 days after the index procedure
13. A co-morbid disease or condition that could confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments
14. 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)
15. Active participation in another investigational drug or device treatment study
16. 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

Primary outcomes:
measure: Number of patients with no incidence of device and/or procedure related Major Adverse Events (MAEs)
timeFrame: 30 days from implantation procedure
measure: Number of patients with Procedure Success
timeFrame: 30 days from implantation procedure
Secondary outcomes:
measure: Number of patients with no incidence of device and/or procedure related Major Adverse Events (MAEs)
timeFrame: within 3, 6, months,1, 2, 3, 4 and 5 years of implantation procedure
measure: Number of Successful Delivery and Deployment Attempts
timeFrame: within 4 hours of implantation procedure
measure: Number of patients with properly positioned Vine™ in each CCA
timeFrame: within 3, 6, months,1, 2, 3, 4 and 5 years of implantation procedure
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Ziekenhuis
city: Antwerp
country: Belgium
facility: ZNA Stuivenberg
city: Prague
country: Czechia
facility: Na Homolce Hospital
city: Nieuwegein
country: Netherlands
facility: Sint-Antonius ziekenhuis
Study officials:
affiliation: Na Homolca Hospital
name: Petr Neuzil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Antonius Hospital
name: Jan Van der Heijden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: OLV Ziekenhuis
name: Tom De Potter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ZNA Stuivenberg
name: Stefan Verheye, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reddy VY, Neuzil P, de Potter T, van der Heyden J, Tromp SC, Rensing B, Jiresova E, Dujka L, Lekesova V. Permanent Percutaneous Carotid Artery Filter to Prevent Stroke in Atrial Fibrillation Patients: The CAPTURE Trial. J Am Coll Cardiol. 2019 Aug 20;74(7):829-839. doi: 10.1016/j.jacc.2019.04.035. Epub 2019 May 11.