Carotid Artery ImPlant for Trapping UpstReam Emboli <br>(CAPTURE) for Preventing Stroke in Atrial Fibrillation <br>Patients

Completed

• Conditions: Artrial fibrilation - abnormal heart rhythm; 10007521; 10014523

• Registration Number: NL-OMON48800
• Lead Sponsor: Javelin Medical Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 2

Inclusion Criteria

1. Atrial fibrillation (AF)
2. CHA2DS2-VASc score >= 2
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: >= 4.8mm 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-Primary Safety Endpoints<br /><br>Incidence of device and/or procedure related Major Adverse Events (MAEs) within<br /><br>30 days of the final index procedure.<br /><br>MAEs are defined as:<br /><br>* Death<br /><br>* Major and minor strokes<br /><br>* Major bleeding<br /><br>* Common carotid artery (CCA) stenosis > 70%<br /><br>* S-3 Implant migration<br /><br>* CCA thrombus<br /><br>* Any complications in the CCA requiring endovascular treatment or surgery<br /><br><br /><br>-Primary Feasibility Endpoints<br /><br>Procedure success, defined as:<br /><br>* Proper S-3 Implant position in each CCA within 30 days of the final index<br /><br>procedure</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Secondary Safety Endpoints<br /><br>- Incidence of device and/or procedure related MAEs within 3, 6, and 12<br /><br>months of the final index procedure.<br /><br><br /><br>-Secondary Feasibility Endpoints<br /><br>• Successful delivery and deployment of the Implant in the CCA, defined as<br /><br>proper Implant position within 4 hours of implantation procedure at each CCA<br /><br>• Proper Implant position in each CCA within 3, 6, and 12 months of the final<br /><br>index procedure<br /><br><br /><br>-Secondary Tolerability Endpoints<br /><br>- Patient*s comfort at Post-procedure visit (Up to 4 hours post implantation),<br /><br>at discharge, and at each follow-up visit </p><br>