Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA Funnel Catheter
Start Date
9/9/2024
Completion Date
12/1/2027
Summary
The objective of this study is to assess the safety and effectiveness of mechanical thrombectomy (MT) using the ANA funnel catheter in its intended use, which is to facilitate the navigation and deployment of other neurovascular devices and to allow flow arrest during mechanical thrombectomy procedures performed in subjects experiencing acute ischemic stroke (AIS) secondary to large vessel occlusion (LVO) and treated within 24 hours of symptom onset.
Detailed Description
Similar to other ancillary devices used in MT, the ANA device is designed to facilitate the delivery of stent retrievers and other catheters during these procedures. Its design aims to enhance procedural success and the efficiency of stent retriever-based MT by enabling flow arrest during clot retrieval. This approach has been shown to improve rates of revascularization and favorable clinical outcomes at three months. The use of the ANA to facilitate MT with a stent retriever may provide a simplified approach to flow restriction and could achieve acute reperfusion outcomes comparable to commonly used strategies that combine direct aspiration with an intermediate catheter to actuate clot retrieval with a SR. A dual-arm, prospective, randomized study will be conducted to demonstrate the safety and effectiveness of ANA compared to a conventional approach using cleared stent retrievers for MT. The study will report acute reperfusion success after a single thrombectomy pass with three of the most commonly employed stent retrievers: Solitaire, Trevo, and pRESET. Procedural safety will be assessed by comparing the rate of procedure-related sICH within 24 hours of the intervention between study arms.
Eligibility Criteria
Age Range: 22 years to 85 years
Interventions
ANA Funnel Catheter
Control
Conditions
Locations
Baptist Health Medical Center
Jacksonville, Florida 32207
United States
Grady Memorial Hospital, Emory
Atlanta, Georgia 30322
United States
Advocate Health
Park Ridge, Illinois 60068
United States
University of Iowa
Iowa City, Iowa 52242
United States
Boston Medical Center
Boston, Massachusetts 02118
United States
University of Buffalo Neurosurgery
Buffalo, New York 14203
United States
Mount Sinai Hospital
New York, New York 10029
United States
Oregon Health & Science University
Portland, Oregon 97239
United States
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania 15213
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin 53215
United States
Centre Hospitalier Universitaire de Montpellier
Montpellier, 34295
France
Fondation Rothschild
Paris, 75019
France
Hospital Foch
Suresnes, 92150
France
Centre Hospitalier Universitaire de Toulouse
Toulouse, 40031
France
Semmelweis University Hospital
Budapest, 1145
Hungary
Hospital Universitario Vall D'Hebron
Barcelona, 08035
Spain
Hospital Clinic de Barcelona
Barcelona, 08036
Spain
Hospital Clinico San Carlos
Madrid, 28040
Spain
Hospital Virgen de la Arrixaca
Murcia, 30120
Spain
Hospital Universitario Central de Asturias
Oviedo, 33011
Spain
Aydin University Hospital
Istanbul, 34295
Turkey (Türkiye)