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

Primary Purpose

Atrial Fibrillation

Status

Active

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Vine™

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring AF

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Evidence of carotid stenosis > 30% [CCA, internal carotid artery (ICA), or external carotid artery (ECA)
Evidence of any atherosclerotic disease in CCA above the clavicles
Evidence of carotid dissection
Pre-existing stent(s) in CCA
Contraindicated or allergic to antiplatelet therapy, or any medication required during the study
Recent stroke, TIA, or myocardial infarction (MI) within two months prior to index procedure
Female who is pregnant or who is planning to become pregnant during the course of the study
Life expectancy of less than 1 year
Active systemic infection
Known sensitivity to nickel or titanium metals, or their alloys
Known hereditary or acquired coagulation disorders
Any planned surgical or endovascular procedure within 14 days prior to or 30 days after the index procedure
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)
Active participation in another investigational drug or device treatment study
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

Sites / Locations

OLV Ziekenhuis
ZNA Stuivenberg
Na Homolce Hospital
Sint-Antonius ziekenhuis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vine™ implantation bilaterally in the common carotid arteries

Arm Description

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.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

Number of Successful Delivery and Deployment Attempts

Successful Delivery and Deployment Attempts is defined as Proper Vine™ Position

Number of patients with properly positioned Vine™ in each CCA

Proper implant position

Full Information

NCT ID

NCT03571789

First Posted

May 30, 2018

Last Updated

September 27, 2023

Sponsor

Javelin Medical

1. Study Identification

Unique Protocol Identification Number

NCT03571789

Brief Title

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

Acronym

CAPTURE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 12, 2017 (Actual)

Primary Completion Date

December 13, 2018 (Actual)

Study Completion Date

November 13, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Javelin Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Multicenter, prospective, non-randomized, open-label, first-in-human (FIH) study

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vine™ implantation bilaterally in the common carotid arteries

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Vine™

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of patients with no incidence of device and/or procedure related Major Adverse Events (MAEs)

Description

Time Frame

30 days from implantation procedure

Title

Number of patients with Procedure Success

Description

Time Frame

30 days from implantation procedure

Secondary Outcome Measure Information:

Title

Number of patients with no incidence of device and/or procedure related Major Adverse Events (MAEs)

Description

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

Time Frame

within 3, 6, months,1, 2, 3, 4 and 5 years of implantation procedure

Title

Number of Successful Delivery and Deployment Attempts

Description

Successful Delivery and Deployment Attempts is defined as Proper Vine™ Position

Time Frame

within 4 hours of implantation procedure

Title

Number of patients with properly positioned Vine™ in each CCA

Description

Proper implant position

Time Frame

within 3, 6, months,1, 2, 3, 4 and 5 years of implantation procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: Evidence of carotid stenosis > 30% [CCA, internal carotid artery (ICA), or external carotid artery (ECA) Evidence of any atherosclerotic disease in CCA above the clavicles Evidence of carotid dissection Pre-existing stent(s) in CCA Contraindicated or allergic to antiplatelet therapy, or any medication required during the study Recent stroke, TIA, or myocardial infarction (MI) within two months prior to index procedure Female who is pregnant or who is planning to become pregnant during the course of the study Life expectancy of less than 1 year Active systemic infection Known sensitivity to nickel or titanium metals, or their alloys Known hereditary or acquired coagulation disorders Any planned surgical or endovascular procedure within 14 days prior to or 30 days after the index procedure 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) Active participation in another investigational drug or device treatment study 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Petr Neuzil, MD

Organizational Affiliation

Na Homolca Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jan Van der Heijden, MD

Organizational Affiliation

St. Antonius Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Tom De Potter, MD

Organizational Affiliation

OLV Ziekenhuis

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Stefan Verheye, MD

Organizational Affiliation

ZNA Stuivenberg

Official's Role

Principal Investigator

Facility Information:

Facility Name

OLV Ziekenhuis

City

Aalst

Country

Belgium

Facility Name

ZNA Stuivenberg

City

Antwerp

Country

Belgium

Facility Name

Na Homolce Hospital

City

Prague

Country

Czechia

Facility Name

Sint-Antonius ziekenhuis

City

Nieuwegein

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31085320

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

Results Reference

derived

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

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