NCT03892824

Carotid Artery Implant for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants

Carotid Artery ImPlant for Trapping UpstReam Emboli (CAPTURE 2) for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Javelin Medical · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety and performance of the Vine™ Embolic Protection System (embolic filtering device) in atrial fibrillation (AF) patients on top of oral anticoagulants (OAC), and remain at high risk for stroke recurrence. All patients will receive bilateral implants in the common carotid arteries

Detailed description

The Vine™ filter (Vine™ or implant) is a permanent carotid filter designed for stroke prevention in AF patients taking OAC at high stroke risk (CHA2DS2-VASc ≤ 4 and stroke history). This patient population accounts for \~20% of the entire AF population, which is \~300K/year in the United State and EU. The implant is designed to exclude emboli \> 1.4mm in size from reaching the anterior circulation. In AF patients, approximately 80% of strokes are total or partial anterior circulation strokes caused by occlusions of the main branches of the Circle of Willis, mainly M1-2, and rarely A1-2. The diameter of these branches, in the majority of cases, is \> 1.5 mm

Conditions

• Atrial Fibrillation
• Stroke

Interventions

Type	Name	Description
DEVICE	Vine™ Embolic Protection System	The system includes the implant and the Vine™ Inserter (inserter) manufactured by Javelin Medical LTD (Israel). The inserter comprises a Motor Unit and a Needle Unit ("Needle Unit") available in two sizes. The system is operable when the Needle Unit is loaded with the implant (labeled "Loaded Needle Unit") and connected to the Motor Unit. A flag indicating the needle orientation is attached to the needle luer. The implant is automatically deployed from the needle upon activation of the operating button.

Timeline

• Start date: 2019-04-15
• Primary completion: 2024-10-24
• Completion: 2027-10-24
• First posted: 2019-03-27
• Last updated: 2025-02-20

Locations

17 sites across 8 countries: Belgium, Czechia, Germany, Greece, Hungary, Israel, Poland, Spain