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

NCT ID: NCT03571789

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-12
• Study Completion Date: 2023-11-28

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Vine™

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Javelin Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Petr Neuzil, MD

Role: PRINCIPAL_INVESTIGATOR

Na Homolca Hospital

Jan Van der Heijden, MD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Tom De Potter, MD

Role: PRINCIPAL_INVESTIGATOR

OLV Ziekenhuis

Stefan Verheye, MD

Role: PRINCIPAL_INVESTIGATOR

ZNA Stuivenberg

Locations

OLV Ziekenhuis

Aalst, , Belgium

ZNA Stuivenberg

Antwerp, , Belgium

Na Homolce Hospital

Prague, , Czechia

Sint-Antonius ziekenhuis

Nieuwegein, , Netherlands

Countries

Belgium; Czechia; Netherlands

References

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.

Reference Type: DERIVED

PMID: 31085320 (View on PubMed)

Other Identifiers

CL-150

Identifier Type: -

Identifier Source: org_study_id