Acute Ischemic Stroke From Large Vessel OcclusionATHENANCT06370182
Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA Funnel Catheter
A study testing ANA Funnel Catheter in people with Acute Ischemic Stroke From Large Vessel Occlusion, run by Anaconda Biomed S.L. at 22 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke From Large Vessel Occlusion
- What is being tested?
- ANA Funnel Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 22 sitesin 5 countries
- Study dates
- 9 Sep 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
- 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.
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- 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.
- Evidence of intracranial tumor (except asymptomatic meningioma of ≤ 2cm in diameter).
- Suspicion of aortic dissection, presumed septic embolus, or suspicion of bacterial endocarditis.
- History of preexisting stent proximal to or at the occlusion site that may preclude safe deployment or recovery of the stent retriever.
- 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.
Trial locations and contacts
22 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Tina Cordaro contact
22 sites in 5 countries
United States11 sites, 11 recruiting
- Recruiting
Grady Memorial Hospital, Emory
Atlanta, Georgia, 30322
(404) 778-1700
Diogo Haussen
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
617-638-6609
Mohamad Abdalkader
- Recruiting
University of Buffalo Neurosurgery
Buffalo, New York, 14203
716-218-1000
Rosalind Lai
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
319-353-6629
Edgar Samaniego
- Recruiting
Baptist Health Medical Center
Jacksonville, Florida, 32207
(+1) 904-487-2469
Ricardo Hanel
- Recruiting
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Sudeepta Dandapat
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
615-322-7417
Michael Froehler
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
(+1)7634969283
Shahram Majidi
- Recruiting
Advocate Health
Park Ridge, Illinois, 60068
847-430-6108
Demetrius Lopes
- Recruiting
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, 15213
Alhamza Al-Bayati
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
503-494-8450
Scott Rewinkel
Spain5 sites, 5 recruiting
- Recruiting
Hospital Universitario Vall D'Hebron
Barcelona, 08035
Alejandro Tomasello
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
Jordi Blasco
- Recruiting
Hospital Clinico San Carlos
Madrid, 28040
699-856-388
Manuel Moreu
- Recruiting
Hospital Virgen de la Arrixaca
Murcia, 30120
Joaquin Zamarro
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, 33011
Pedro Vega
France4 sites, 4 recruiting
- Recruiting
Centre Hospitalier Universitaire de Montpellier
Montpellier, 34295
+33(0) 467 337 532
Vincent Costalat
- Recruiting
Fondation Rothschild
Paris, 75019
(+33) 1 48 03 68 29
Michel Piotin
- Recruiting
Hospital Foch
Suresnes, 92150
331-462-52526
Arturo Consoli
- Recruiting
Centre Hospitalier Universitaire de Toulouse
Toulouse, 40031
0033561772339
Christophe Cognard
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University Hospital
Budapest, 1145
Sandor Nardai
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Aydin University Hospital
Istanbul, 34295
+90 532 594 29 33
Serdar Geyik
About this study
Official title: 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.
Read the 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.
- Being tested
- ANA Funnel Catheter, Control
- Keywords
- flow arrest, flow restriction, funnel, guide catheter, mechanical thrombectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANA Funnel CatheterDevice
Mechanical thrombectomy using a stent retriever delivered by the ANA device that enables local flow restriction when deployed.
ControlDevice
Mechanical thrombectomy using a stent retriever delivered by an approved guide catheter with or without an intermediate catheter and aspiration per conventional techniques.
| Study group | Role | What they receive |
|---|---|---|
| ANA Funnel Catheter Group | Experimental | Mechanical thrombectomy using a stent retriever delivered by the ANA device. Receives: Device: ANA Funnel Catheter |
| Control Group | Active comparator | Mechanical thrombectomy using a stent retriever delivered by an approved guide catheter. Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Within 24 hours of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start9 Sep 2024
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic Stroke From Large Vessel OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 327 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anaconda Biomed S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adnan Siddiqui, MD, PhD, FAHA, Principal investigator, Jacobs School of Medicine & Biomedical SciencesSantiago Ortega-Gutierrez, MD, MSc, FAHA, FSVIN, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370182
- Sponsor's protocol ID
- ANA2401
- Acronym
- ATHENA
- Status last verified
- Dec 2025
- First submitted
- 11 Apr 2024
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06370182
- Acronym / sponsor ID
- ATHENA / ANA2401
- Keywords
- flow arrest, flow restriction, funnel, guide catheter, mechanical thrombectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 327 participants (estimated)
- Lead sponsor
- Anaconda Biomed S.L.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANA Funnel Catheter Group | Experimental | Device: ANA Funnel CatheterMechanical thrombectomy using a stent retriever delivered by the ANA device. |
| Control Group | Active comparator | Device: ControlMechanical thrombectomy using a stent retriever delivered by an approved guide catheter. |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (21 listed)
- Subjects who meet any of the exclusion criteria will be ineligible for participation in the study.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANA Funnel CatheterMechanical thrombectomy using a stent retriever delivered by the ANA device that enables local flow restriction when deployed. | Device | ANA Funnel Catheter Group |
| ControlMechanical thrombectomy using a stent retriever delivered by an approved guide catheter with or without an intermediate catheter and aspiration per conventional techniques. | Device | Control Group |
Primary outcome
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tina Cordaro contact
Adnan Siddiqui, MD, PhD, FAHA principal investigator
Jacobs School of Medicine & Biomedical Sciences
Santiago Ortega-Gutierrez, MD, MSc, FAHA, FSVIN principal investigator
University of Iowa
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANA Funnel Catheter in people with Acute Ischemic Stroke From Large Vessel Occlusion, run by Anaconda Biomed S.L. at 22 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Spain, France, Hungary, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hendrik Lambert ((404) 277-7280, athena@anaconda.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.