Clinical trial NCT03892824: Carotid Artery Implant for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants
Official title: Carotid Artery ImPlant for Trapping UpstReam Emboli (CAPTURE 2) for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Stroke
Keywords: AF
Stroke
Filter
Emboli
Carotid
OAC
Lead sponsor: Javelin Medical
Sponsor class: INDUSTRY
Collaborators: name: Genae
First posted: 2019-03-27
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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

Eligibility criteria: Inclusion Criteria:

* Documented AF
* CHA2DS2-VASc score ≥ 4 and history of ischemic stroke (including TIA with positive neuro-imaging)
* No contra-indication for patient to receive an OAC, either vitamin K antagonist (VKA) or novel oral anticoagulant (NOAC) for the duration of the study
* Age \> 50 years
* Maximal (systolic) CCA diameter range: ≥ 4.8mm and ≤ 9.8mm
* CCA accessibility: up to 40mm from skin to CCA center, safe approach
* Implantation segment free of atherosclerotic disease as determined by ultrasound imaging
* Patient is able and willing to provide informed consent

Exclusion Criteria:

* Evidence of carotid stenosis \> 30% \[CCA, internal carotid artery (ICA), or external carotid artery (ECA)\]
* Evidence of carotid dissection
* Pre-existing stent(s) in CCA
* Female who is pregnant or who is planning to become pregnant during the course of the study
* Life expectancy of less than two years
* Active systemic infection
* Known sensitivity to nickel or titanium metals, or their alloys
* Known hereditary or acquired coagulation disorders
* Any planned surgical or endovascular treatment within 30 days after the implantation 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
* Inability to complete all scheduled follow-up
* Any other condition that in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient's ability to complete the study
* History of intracerebral hemorrhage (ICH) and/or hemorrhagic stroke
* Event of stroke/TIA in the past 14 days

Primary outcomes:
measure: Number of participants that had Ischemic Stroke and/or Hemorrhagic stroke and/or implantation procedure complications
timeFrame: 30 days from implantation procedure
Secondary outcomes:
measure: Number of participants that had Ischemic Stroke and/or Hemorrhagic stroke and/or Device complications.
timeFrame: one and two years from implantation procedure
measure: Number of properly positioned implants
timeFrame: 30 days from implantation procedure
measure: Number of participants that had disabling strokes
timeFrame: 30 days, one and two years from implantation procedure
measure: Number of Implantation success
timeFrame: immediately after the procedure
measure: Number of properly positioned implants
timeFrame: one and two years from implantation procedure
measure: Number of observed thrombi on the device
timeFrame: 30 days, one and two years from implantation procedure
measure: Number of death cases
timeFrame: one and two years from implantation procedure
measure: Number of strokes (any kind)
timeFrame: one and two years from implantation procedure
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Ziekenhuis
city: Antwerp
country: Belgium
facility: ZNA Stuivenberg
city: Prague
country: Czechia
facility: Na Homolce Hospital
city: Essen
country: Germany
facility: Alfried-Krupp Krankenhaus Rüttenscheid
city: Frankfurt
country: Germany
facility: Cardio Vasculäres Centrum Frankfurt
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum Bethanien
city: Athens
country: Greece
facility: General Hospital of Athens "Hippokrateio"
city: Athen
country: Greece
facility: Laiko Hospital
city: Larissa
country: Greece
facility: University General Hospital of Larisa
city: Thessaloníki
country: Greece
facility: European Interbalkan Medical Center
city: Budapest
country: Hungary
facility: Gottsegen György Hungarian Institute of Cardiology
city: Haifa
country: Israel
facility: Carmel
city: Jerusalem
country: Israel
facility: Shaari Tzedek
city: Petah tikva
country: Israel
facility: Rabin Medical Center (RMC)
city: Tiberias
country: Israel
facility: Poria
city: Poznań
country: Poland
facility: Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Pracownia Hemodynamiki Serca
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
Study officials:
References: