RecruitingNot ApplicableNCT06370182

Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA Funnel Catheter

A Prospective, Randomized, Dual-arm Multi-center Study to Assess the Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA Funnel Catheter in Combination With a Stent Retriever

Sponsor

Anaconda Biomed S.L.

Enrollment

327 participants

Start Date

Sep 9, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Ischemic Stroke From Large Vessel Occlusion

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.

Eligibility

Min Age: 22 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This randomized controlled trial is evaluating a medical device called the ANA funnel catheter — used during mechanical thrombectomy, a procedure to remove blood clots from blocked brain arteries — to see whether it helps achieve faster and more complete restoration of blood flow in people experiencing acute ischemic stroke. The ANA device works by temporarily stopping blood flow during clot removal with a stent retriever, which may improve the chances of successful reperfusion. Adults aged 22 to 85 who are experiencing an acute ischemic stroke with a large vessel occlusion, have a baseline neurological deficit score between 6 and 25, and can be treated within 16 hours of symptom onset may be eligible. Participation involves receiving the mechanical thrombectomy procedure with or without the ANA device and being followed up for clinical outcome assessments at 90 days. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEANA Funnel Catheter

Mechanical thrombectomy using a stent retriever delivered by the ANA device that enables local flow restriction when deployed.

DEVICEControl

Mechanical thrombectomy using a stent retriever delivered by an approved guide catheter with or without an intermediate catheter and aspiration per conventional techniques.

Locations(22)

Baptist Health Medical Center

Jacksonville, Florida, United States

Grady Memorial Hospital, Emory

Atlanta, Georgia, United States

Advocate Health

Park Ridge, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

Boston Medical Center

Boston, Massachusetts, United States

University of Buffalo Neurosurgery

Buffalo, New York, United States

Mount Sinai Hospital

New York, New York, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Centre Hospitalier Universitaire de Montpellier

Montpellier, France

Fondation Rothschild

Paris, France

Hospital Foch

Suresnes, France

Centre Hospitalier Universitaire de Toulouse

Toulouse, France

Semmelweis University Hospital

Budapest, Hungary

Hospital Universitario Vall D'Hebron

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Virgen de la Arrixaca

Murcia, Spain

Hospital Universitario Central de Asturias

Oviedo, Spain

Aydin University Hospital

Istanbul, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

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