Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients

Atrial Fibrillation Clinical Trial

— CAPTURE  

Official title:

Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03571789
• Other study ID #: CL-150
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 12, 2017
• Est. completion date: November 30, 2028

Study information

• Verified date: September 2023
• Source: Javelin Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: November 30, 2028
• Est. primary completion date: December 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Vine™
The Vine™ is made of a super-elastic nitinol wire comprises a helix that resides within the CCA lumen and a linear stem that traverses the CCA wall. The helix includes three segments: supporting coils, filter, and leading coils. The device is available in sizes of 6.0mm - 10.0mm (in 0.5mm intervals) to accommodate individual CCA diameters

Locations

Country	Name	City	State
Belgium	OLV Ziekenhuis	Aalst
Belgium	ZNA Stuivenberg	Antwerp
Czechia	Na Homolce Hospital	Prague
Netherlands	Sint-Antonius ziekenhuis	Nieuwegein

Sponsors (1)

Lead Sponsor	Collaborator
Javelin Medical

Countries where clinical trial is conducted

Belgium,  Czechia,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with no incidence of device and/or procedure related Major Adverse Events (MAEs)	Major Adverse Events (MAEs) are defined as: Death; Major and minor strokes; Major bleeding; Common carotid artery (CCA) stenosis > 70%; Vine™ migration; CCA thrombus; Any complications in the CCA requiring endovascular treatment or surgery	30 days from implantation procedure
Primary	Number of patients with Procedure Success	Procedure Success is defined as Proper Vine™ Position in each CCA; Proper Vine™ Position is defined as: Supporting coil in contact with artery walls; No migration; No fracture; No Vine™ coils or portions thereof visible outside the arterial lumen; No entangled or overlapping coils	30 days from implantation procedure
Secondary	Number of patients with no incidence of device and/or procedure related Major Adverse Events (MAEs)	Death; Major and minor strokes; Major bleeding; Common carotid artery (CCA) stenosis > 70%; Vine™ migration; CCA thrombus; Any complications in the CCA requiring endovascular treatment or surgery	within 3, 6, months,1, 2, 3, 4 and 5 years of implantation procedure
Secondary	Number of Successful Delivery and Deployment Attempts	Successful Delivery and Deployment Attempts is defined as Proper Vine™ Position	within 4 hours of implantation procedure
Secondary	Number of patients with properly positioned Vine™ in each CCA	Proper implant position	within 3, 6, months,1, 2, 3, 4 and 5 years of implantation procedure