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

December 5, 2025 updated by: Anaconda Biomed S.L.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

327

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Montpellier, France, 34295
        • Recruiting
        • Centre Hospitalier Universitaire de Montpellier
        • Contact:
          • Phone Number: +33(0) 467 337 532
        • Principal Investigator:
          • Vincent Costalat
      • Paris, France, 75019
        • Recruiting
        • Fondation Rothschild
        • Contact:
          • Phone Number: (+33) 1 48 03 68 29
        • Principal Investigator:
          • Michel Piotin
      • Suresnes, France, 92150
        • Recruiting
        • Hospital Foch
        • Contact:
          • Phone Number: 331-462-52526
        • Principal Investigator:
          • Arturo CONSOLI
      • Toulouse, France, 40031
        • Recruiting
        • Centre Hospitalier Universitaire de Toulouse
        • Contact:
          • Phone Number: 0033561772339
        • Principal Investigator:
          • Christophe COGNARD
  • Hungary
      • Budapest, Hungary, 1145
        • Recruiting
        • Semmelweis University Hospital
        • Principal Investigator:
          • Sandor Nardai
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron
        • Principal Investigator:
          • Alejandro Tomasello
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic De Barcelona
        • Principal Investigator:
          • Jordi Blasco
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
        • Principal Investigator:
          • Manuel Moreu
        • Contact:
          • Phone Number: 699-856-388
      • Murcia, Spain, 30120
        • Recruiting
        • Hospital Virgen de la Arrixaca
        • Principal Investigator:
          • Joaquin Zamarro
      • Oviedo, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Principal Investigator:
          • Pedro Vega
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34295
        • Recruiting
        • Aydin University Hospital
        • Contact:
          • Phone Number: +90 532 594 29 33
        • Principal Investigator:
          • Serdar Geyik
  • United States
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist Health Medical Center
        • Principal Investigator:
          • Ricardo Hanel
        • Contact:
          • Phone Number: (+1) 904-487-2469
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Grady Memorial Hospital, Emory
        • Contact:
          • Phone Number: (404) 778-1700
        • Principal Investigator:
          • Diogo Haussen
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Recruiting
        • Advocate Health
        • Contact:
          • Phone Number: 847-430-6108
        • Principal Investigator:
          • Demetrius Lopes
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Contact:
          • Phone Number: 319-353-6629
        • Principal Investigator:
          • Edgar Samaniego
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center
        • Contact:
          • Phone Number: 617-638-6609
        • Principal Investigator:
          • Mohamad AbdalKader
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • University of Buffalo Neurosurgery
        • Contact:
          • Phone Number: 716-218-1000
        • Principal Investigator:
          • Rosalind Lai
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
          • Phone Number: (+1)7634969283
        • Principal Investigator:
          • Shahram Majidi
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
          • Phone Number: 503-494-8450
        • Principal Investigator:
          • Scott Rewinkel
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburg Medical Center
        • Principal Investigator:
          • Alhamza Al-Bayati
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
          • Phone Number: 615-322-7417
        • Principal Investigator:
          • Michael Froehler
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora St. Luke's Medical Center
        • Principal Investigator:
          • Sudeepta Dandapat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

Subjects meeting all inclusion criteria will be considered for enrollment in the study.

  1. Age 22 to 85 years.
  2. Informed consent was obtained from subject or acceptable subject surrogate (e.g., next of kin, or legal representative).
  3. A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
  4. Baseline NIHSS obtained prior to procedure ≥ 6 points and ≤ 25 points.
  5. Pre-ictal mRS score of 0,1 or 2.
  6. 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.
  7. 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.
  8. 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.

  9. 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)
  10. The subject is indicated for a neurovascular thrombectomy procedure with an approved stent retriever per its Instructions for Use.

Key Exclusion Criteria:

Subjects who meet any of the exclusion criteria will be ineligible for participation in the study.

The following exclusion criteria will be assessed pre-operatively:

  1. Subject was diagnosed with a stroke in the past year.
  2. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
  3. 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.
  4. Known baseline glucose of <50 mg/dL or >400 mg/dL.
  5. Severe, sustained uncontrolled hypertension refractory to treatment (systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg).
  6. Serious, advanced, or terminal disease with anticipated life expectancy of less than 1 year.
  7. Known cancer with metastases.
  8. History of life-threatening allergy (more than rash) to contrast medium.
  9. Known renal insufficiency with creatinine ≥3 mg/dL or glomerular filtration rate (GFR) <30 mL/min.
  10. Subject is a current user or has a recent history of cocaine &/or heroin use.
  11. Known pregnancy and/or lactating female.
  12. Subject is participating in a concurrent study involving an investigational drug or device that would impact the primary endpoint of this study.
  13. Subject is unlikely to be available for a 90-day follow-up (e.g. no fixed home address, visitor from overseas, etc.)
  14. CT or MRI evidence of hemorrhage (the presence of microbleeds is allowed).
  15. Significant mass effect with midline shift.
  16. Evidence of intracranial tumor (except asymptomatic meningioma of ≤ 2cm in diameter).
  17. Suspicion of aortic dissection, presumed septic embolus, or suspicion of bacterial endocarditis.
  18. History of preexisting stent proximal to or at the occlusion site that may preclude safe deployment or recovery of the stent retriever.
  19. Vessel tortuosity too difficult to allow endovascular access of the intracranial ICA per investigator judgement. Indicators of vessel tortuosity include but are not limited to the presence of carotid loops and type 3 aortic arches.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ANA Funnel Catheter Group
Mechanical thrombectomy using a stent retriever delivered by the ANA device.
Device: ANA Funnel Catheter
Mechanical thrombectomy using a stent retriever delivered by the ANA device that enables local flow restriction when deployed.
Active Comparator: Control Group
Mechanical thrombectomy using a stent retriever delivered by an approved guide catheter.
Device: Control
Mechanical thrombectomy using a stent retriever delivered by an approved guide catheter with or without an intermediate catheter and aspiration per conventional techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of symptomatic intracranial hemorrhage (sICH), attributable to the device or procedure.
Time Frame: Within 24 hours of the 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
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.
Time Frame: intra-operative
Reperfusion (eTICI 2c-3) to be assessed by an independent Core Lab.
intra-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anaconda Biomed S.L.

Investigators

  • Principal Investigator: Adnan Siddiqui, MD, PhD, FAHA, Jacobs School of Medicine & Biomedical Sciences
  • Principal Investigator: Santiago Ortega-Gutierrez, MD, MSc, FAHA, FSVIN, University of Iowa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 11, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANA2401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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