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Using the Anaconda ANA5 device for treating acute ischemic stroke

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

NA · Anaconda Biomed S.L. · NCT06370182

This study is testing a new device called the Anaconda ANA5 to see if it can help people with acute ischemic stroke get better treatment results compared to standard methods.

Quick facts

PhaseNA
Study typeInterventional
Enrollment327 (estimated)
Ages22 Years to 85 Years
SexAll
SponsorAnaconda Biomed S.L. (industry)
Locations22 sites (Jacksonville, Florida and 21 other locations)
Trial IDNCT06370182 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the Anaconda ANA5 funnel catheter in performing mechanical thrombectomy for patients suffering from acute ischemic stroke due to large vessel occlusion. The device is designed to facilitate the insertion of stent retrievers and other catheters during the procedure, allowing for improved flow restriction and potentially better outcomes. Participants will be treated within 24 hours of symptom onset, and the study will compare the results of the ANA device against conventional techniques. The goal is to determine if the ANA device enhances procedural success without compromising safety.

Who should consider this trial

Good fit: Ideal candidates are individuals experiencing a new focal disabling neurologic deficit consistent with acute cerebral ischemia, with a baseline NIHSS score between 8 and 25, and who can be treated within 24 hours of symptom onset.

Not a fit: Patients who have had a stroke in the past year or those with contraindications to mechanical thrombectomy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved outcomes for patients with acute ischemic stroke by enhancing the effectiveness of thrombectomy procedures.

How similar studies have performed: Previous studies have shown the value of flow arrest during mechanical thrombectomy, indicating that this approach has potential based on established techniques.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Jacksonville, Florida and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Acute Ischemic Stroke From Large Vessel Occlusion, flow arrest, flow restriction, funnel, guide catheter, mechanical thrombectomy

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.