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

• ClinicalTrials.gov Identifier: NCT03571789
• Recruitment Status: Active, not recruiting
• First Posted: June 28, 2018
• Last Update Posted: July 30, 2020
• Sponsor: Javelin Medical
• Information provided by (Responsible Party): Javelin Medical

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation	Device: Vine™	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Multicenter, prospective, non-randomized, open-label, first-in-human (FIH) study
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients
• Actual Study Start Date: September 12, 2017
• Actual Primary Completion Date: December 13, 2018
• Estimated Study Completion Date: November 13, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Vine™ implantation bilaterally in the common carotid arteries; Vine™ is a permanent carotid filter made from a single nitinol wire. It is configured to capture emboli exceeding 1.2mm in size, which originate in the heart and large arteries below the neck. Vine™ has a helical structure, with leading and supporting coils interposed by a filter section.	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

Outcome Measures

Primary Outcome Measures :

1. Number of patients with no incidence of device and/or procedure related Major Adverse Events (MAEs) [ Time Frame: 30 days from implantation procedure ]

   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
2. Number of patients with Procedure Success [ Time Frame: 30 days from implantation procedure ]

   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

Secondary Outcome Measures :

1. Number of patients with no incidence of device and/or procedure related Major Adverse Events (MAEs) [ Time Frame: within 3, 6, months,1, 2, 3, 4 and 5 years of implantation procedure ]

   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
2. Number of Successful Delivery and Deployment Attempts [ Time Frame: within 4 hours of implantation procedure ]
   Successful Delivery and Deployment Attempts is defined as Proper Vine™ Position
3. Number of patients with properly positioned Vine™ in each CCA [ Time Frame: within 3, 6, months,1, 2, 3, 4 and 5 years of implantation procedure ]
   Proper implant position

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Belgium

OLV Ziekenhuis

Aalst, Belgium

ZNA Stuivenberg

Antwerp, Belgium

Czechia

Na Homolce Hospital

Prague, Czechia

Netherlands

Sint-Antonius ziekenhuis

Nieuwegein, Netherlands

Sponsors and Collaborators

Javelin Medical

Investigators

• Principal Investigator: Petr Neuzil, MD; Na Homolca Hospital
• Principal Investigator: Jan Van der Heijden, MD; St. Antonius Hospital
• Principal Investigator: Tom De Potter, MD; OLV Ziekenhuis
• Principal Investigator: Stefan Verheye, MD; ZNA Stuivenberg

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Erratum in: J Am Coll Cardiol. 2019 Aug 20;74(7):1013-1014.

• Responsible Party: Javelin Medical
• ClinicalTrials.gov Identifier: NCT03571789
• Other Study ID Numbers: CL-150
• First Posted: June 28, 2018
• Last Update Posted: July 30, 2020
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Javelin Medical:

AF

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes