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

Status: Recruiting
Location: See all (22) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 85
Healthy Volunteers: f
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∙ Subjects meeting all inclusion criteria will be considered for enrollment in the study.

• Age 22 to 85 years.

• Informed consent was obtained from subject or acceptable subject surrogate (e.g., next of kin, or legal representative).

• A new focal disabling neurologic deficit consistent with acute cerebral ischemia.

• Baseline NIHSS obtained prior to procedure ≥ 6 points and ≤ 25 points.

• Pre-ictal mRS score of 0,1 or 2.

• Treatable within 16 hours of symptom onset, defined as point in time when the subject was last observed to be asymptomatic; treatment start is defined by arterial puncture time.

• If indicated, thrombolytic therapy shall be initiated per the institution's usual care and the most recent version of the AHA/ASA Guidelines. Subjects eligible for IV thrombolysis should receive it without delay.

• Occlusion (eTICI ≤ 1 flow) of the terminal carotid artery, middle cerebral artery M1 segment or, dominant or proximal M2 segment, indicated for mechanical thrombectomy, confirmed with conventional angiography or CTA/MRA.

• Imaging criteria:

‣ Perfusion weighted criterion: volume of diffusion restriction visually assessed

‣ ≤ 50 mL on CTP/MRP, or

⁃ CT criterion: Alberta Stroke program early CT score (ASPECTS) 6 to 10 on baseline CT/DWI-MRI. (Inclusion of subjects with ASPECTS 5 is permitted at centers performing scoring on MRI)

⁃ The subject is indicated for a neurovascular thrombectomy procedure with an approved stent retriever per its Instructions for Use.

Locations
United States
Florida
Baptist Health Medical Center
RECRUITING
Jacksonville
Georgia
Grady Memorial Hospital, Emory
RECRUITING
Atlanta
Iowa
University of Iowa
RECRUITING
Iowa City
Illinois
Advocate Health
RECRUITING
Park Ridge
Massachusetts
Boston Medical Center
RECRUITING
Boston
New York
University of Buffalo Neurosurgery
RECRUITING
Buffalo
Mount Sinai Hospital
RECRUITING
New York
Oregon
Oregon Health & Science University
RECRUITING
Portland
Pennsylvania
University of Pittsburg Medical Center
RECRUITING
Pittsburgh
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Wisconsin
Aurora St. Luke's Medical Center
RECRUITING
Milwaukee
Other Locations
France
Centre Hospitalier Universitaire de Montpellier
RECRUITING
Montpellier
Fondation Rothschild
RECRUITING
Paris
Hospital Foch
RECRUITING
Suresnes
Centre Hospitalier Universitaire de Toulouse
RECRUITING
Toulouse
Hungary
Semmelweis University Hospital
RECRUITING
Budapest
Spain
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital Universitario Vall D'Hebron
RECRUITING
Barcelona
Hospital Clinico San Carlos
RECRUITING
Madrid
Hospital Virgen de la Arrixaca
RECRUITING
Murcia
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Turkey
Aydin University Hospital
RECRUITING
Istanbul
Contact Information
Primary
Hendrik Lambert
athena@anaconda.bio
(404) 277-7280
Backup
Tina Cordaro
athena@anaconda.bio
Time Frame
Start Date: 2024-09-09
Estimated Completion Date: 2027-12
Participants
Target number of participants: 327
Treatments
Experimental: ANA Funnel Catheter Group
Mechanical thrombectomy using a stent retriever delivered by the ANA device.
Active_comparator: Control Group
Mechanical thrombectomy using a stent retriever delivered by an approved guide catheter.
Related Therapeutic Areas
Sponsors
Leads: Anaconda Biomed S.L.

This content was sourced from clinicaltrials.gov