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

NCT06370182 | Recruiting DMC FDA Device

• 1 other identifier: ANA2401
• Study Type: interventional
• Target: 327
• Locations: 5 countries
• Sites: 22

Brief 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.

Conditions

Acute Ischemic Stroke From Large Vessel Occlusion

Keywords

flow arrest; flow restriction; funnel; guide catheter; mechanical thrombectomy

Outcome Measures

Primary Outcomes (2)

• Proportion of subjects with "near-complete" reperfusion after one thrombectomy pass (FPE, eTICI 2c-3, extended Thrombolysis in Cerebral Infarction scale) in the target vessel.

  Reperfusion (eTICI 2c-3) to be assessed by an independent Core Lab.

  intra-operative

• Rate of symptomatic intracranial hemorrhage (sICH), attributable to the device or procedure.

  Extent of hemorrhage to be assessed by an independent Core Lab, symptoms to be assessed by the Data Monitoring Committee (DMC).

  Within 24 hours of the procedure

Study Arms (2)

ANA Funnel Catheter Group

EXPERIMENTAL

Mechanical thrombectomy using a stent retriever delivered by the ANA device.

Device: ANA Funnel Catheter

Control Group

ACTIVE COMPARATOR

Mechanical thrombectomy using a stent retriever delivered by an approved guide catheter.

Device: Control

Interventions

ANA Funnel Catheter DEVICE

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

ANA Funnel Catheter Group

Control DEVICE

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

Control Group

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subject was diagnosed with a stroke in the past year.
• Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
• Known hemorrhagic diathesis, coagulation factor deficiency, oral anticoagulant therapy with antivitamin K, with INR \>3.0, or thrombocytopenia - baseline platelet count \< 50,000 platelets/mL.
• Known baseline glucose of \<50 mg/dL or \>400 mg/dL.
• Severe, sustained uncontrolled hypertension refractory to treatment (systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg).
• Serious, advanced, or terminal disease with anticipated life expectancy of less than 1 year.
• Known cancer with metastases.
• History of life-threatening allergy (more than rash) to contrast medium.
• Known renal insufficiency with creatinine ≥3 mg/dL or glomerular filtration rate (GFR) \<30 mL/min.
• Subject is a current user or has a recent history of cocaine \&/or heroin use.
• Known pregnancy and/or lactating female.
• Subject is participating in a concurrent study involving an investigational drug or device that would impact the primary endpoint of this study.
• Subject is unlikely to be available for a 90-day follow-up (e.g. no fixed home address, visitor from overseas, etc.)
• CT or MRI evidence of hemorrhage (the presence of microbleeds is allowed).
• Significant mass effect with midline shift.

Sponsors & Collaborators

• Anaconda Biomed S.L.: lead

Study Sites (22)

Baptist Health Medical Center

Jacksonville, Florida, 32207, United States

RECRUITING

Grady Memorial Hospital, Emory

Atlanta, Georgia, 30322, United States

RECRUITING

Advocate Health

Park Ridge, Illinois, 60068, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

University of Buffalo Neurosurgery

Buffalo, New York, 14203, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

RECRUITING

Centre Hospitalier Universitaire de Montpellier

Montpellier, 34295, France

RECRUITING

Fondation Rothschild

Paris, 75019, France

RECRUITING

Hospital Foch

Suresnes, 92150, France

RECRUITING

Centre Hospitalier Universitaire de Toulouse

Toulouse, 40031, France

RECRUITING

Semmelweis University Hospital

Budapest, 1145, Hungary

RECRUITING

Hospital Universitario Vall D'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Virgen de la Arrixaca

Murcia, 30120, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

RECRUITING

Aydin University Hospital

Istanbul, 34295, Turkey (Türkiye)

RECRUITING

Study Officials

• Adnan Siddiqui, MD, PhD, FAHA

  Jacobs School of Medicine & Biomedical Sciences

  PRINCIPAL INVESTIGATOR

• Santiago Ortega-Gutierrez, MD, MSc, FAHA, FSVIN

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hendrik Lambert

CONTACT

(404) 277-7280; athena@anaconda.bio

Tina Cordaro

CONTACT

athena@anaconda.bio

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 17, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

FR (4); TU (1); HU (1); US (11); ES (5)