Mechanical Thrombectomy for Stroke

(ATHENA Trial)

Recruiting at 22 trial locations

Overseen By Tina Cordaro

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Anaconda Biomed S.L.

Must not be taking: Anticoagulants, Cocaine, Heroin

Disqualifiers: Recent stroke, Cancer, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

327 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new tool, the ANA funnel catheter, for treating strokes caused by large blood vessel blockages. The treatment involves a mechanical thrombectomy, a procedure that removes clots to restore blood flow to the brain. Participants will receive either the new ANA device or a standard method for comparison. Individuals who have experienced a sudden, severe stroke and can be treated within 24 hours of symptom onset might be suitable for this trial.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance stroke treatment options.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on oral anticoagulant therapy with antivitamin K and have an INR greater than 3.0, you may be excluded from the study.

What prior data suggests that the ANA funnel catheter is safe for mechanical thrombectomy?

Research has shown that the ANA device used in mechanical thrombectomy, a procedure to remove a blood clot from a blood vessel, is safe. Early studies found that it successfully restores blood flow and is generally well-tolerated. An initial study also noted its effectiveness in fully restoring blood flow. Although specific evidence about this device is limited, mechanical thrombectomy remains a common and standard treatment for strokes caused by large vessel blockages. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ANA Funnel Catheter for mechanical thrombectomy in stroke treatment because it offers a new way to deliver stent retrievers. Unlike traditional methods using an approved guide catheter, this experimental technique employs the ANA device, which may provide more precise navigation through blood vessels. This new delivery method could potentially improve the efficiency and success rate of clot removal, offering hope for better outcomes in stroke patients.

What evidence suggests that the ANA funnel catheter is effective for mechanical thrombectomy in acute ischemic stroke?

Research has shown that the ANA funnel catheter, which participants in this trial may receive, can help treat strokes caused by large blood vessel blockages. Studies have found that it often restores blood flow successfully on the first attempt. The device is also considered safe. In many cases, the ANA device quickly and completely restored blood flow. Overall, these findings suggest that the ANA funnel catheter could improve recovery for stroke patients. ^{1 2 3 6 7}

Who Is on the Research Team?

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

Are You a Good Fit for This Trial?

This trial is for adults aged 22-85 with a recent stroke due to large vessel occlusion, who can be treated within 24 hours of symptoms starting. They must have a moderate to severe neurological deficit but no major pre-existing conditions like certain tumors or past strokes, uncontrolled blood pressure, or serious kidney issues.

Inclusion Criteria

Imaging criteria met: diffusion restriction volume ≤ 50 mL on CTP/MRP or ASPECTS 6 to 10 on baseline CT/DWI-MRI

Informed consent obtained from subject or acceptable subject surrogate

Baseline NIHSS ≥ 8 points and ≤ 25 points

Exclusion Criteria

Preexisting stent proximal to or at occlusion site

Vessel tortuosity precluding endovascular access

History of life-threatening allergy to contrast medium

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo mechanical thrombectomy using either the ANA funnel catheter or a conventional stent retriever approach

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including assessment of symptomatic intracranial hemorrhage within 24 hours

24 hours

Extended Follow-up

Participants are monitored for clinical outcomes and revascularization success at three months

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Mechanical Thrombectomy using ANA5 Device

Trial Overview The study tests the safety and effectiveness of the ANA funnel catheter during mechanical thrombectomy in patients with acute ischemic stroke. It's compared against standard care, focusing on its ability to help navigate other devices and stop blood flow temporarily during the procedure.

How Is the Trial Designed?

Group I: ANA Funnel Catheter Group Experimental Treatment 1 Intervention

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

Group II: Control Group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Anaconda Biomed S.L.

Lead Sponsor

Trials

3

Recruited

370+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06370182

Study Details | NCT06370182 | Safety and Effectiveness of ... 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, ...

2. ysioscapital.com ysioscapital.com/2025/04/16/anaconda-biomed-announces-publication-of-anais-study-results-in-the-american-journal-of-neuroradiology/

Anaconda Biomed Announces Publication of ANAIS Study The data demonstrated high rates of reperfusion and first-pass success with a strong safety profile, supporting the ANA device as an adjunct to ...

3. jnis.bmj.com jnis.bmj.com/content/16/Suppl_1/A224

E-228 Clinical results of the anais study The ANA device achieved high rates of recanalization and first pass success, with a good safety profile. Successful reperfusion was superior.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0150986120302856

initial clinical experience with the ANA thrombectomy device In this first-in-human study, the ANA™ device achieved a high rate of complete reperfusion, sudden recanalization, and a good safety profile. Abstract ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8655598/

Outcomes of Mechanical Thrombectomy for Patients With ... This cohort study uses data from the Stroke Thrombectomy and Aneurysm Registry to investigate the safety and effectiveness of mechanical ...

6. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.034783

Safety and Outcomes of Mechanical Thrombectomy in ... There is limited evidence on the outcomes and safety of mechanical thrombectomy (MT) among patients with acute ischemic stroke (AIS) in the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9232250/

Clinical Results of the Advanced Neurovascular Access ... Mechanical thrombectomy (MT) has become the standard of care for acute ischemic stroke due to a large vessel occlusion based on the evidence of pivotal clinical ...