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Clinical Trials in the USA / NCT06370182
Recruiting Not applicable

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

NCT06370182 · tracked via the Priya Life Science USA tracker
Sponsor
Anaconda Biomed S.L.
Phase
Not applicable
Started
2024-09-09
Last updated
2025-12-11

Condition(s) studied

Acute Ischemic Stroke From Large Vessel Occlusion

Investigational drug(s) / intervention(s)

ANA Funnel CatheterControl

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

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

Study 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.

Eligibility

Sex
ALL
Min age
22 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (22)

FacilityCityRegionStatus
Baptist Health Medical Center Jacksonville Florida Recruiting
Grady Memorial Hospital, Emory Atlanta Georgia Recruiting
Advocate Health Park Ridge Illinois Recruiting
University of Iowa Iowa City Iowa Recruiting
Boston Medical Center Boston Massachusetts Recruiting
University of Buffalo Neurosurgery Buffalo New York Recruiting
Mount Sinai Hospital New York New York Recruiting
Oregon Health & Science University Portland Oregon Recruiting
University of Pittsburg Medical Center Pittsburgh Pennsylvania Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
Aurora St. Luke's Medical Center Milwaukee Wisconsin Recruiting
Centre Hospitalier Universitaire de Montpellier Montpellier France Recruiting
Fondation Rothschild Paris France Recruiting
Hospital Foch Suresnes France Recruiting
Centre Hospitalier Universitaire de Toulouse Toulouse France Recruiting
Semmelweis University Hospital Budapest Hungary Recruiting
Hospital Universitario Vall D'Hebron Barcelona Spain Recruiting
Hospital Clinic de Barcelona Barcelona Spain Recruiting
Hospital Clinico San Carlos Madrid Spain Recruiting
Hospital Virgen de la Arrixaca Murcia Spain Recruiting
Hospital Universitario Central de Asturias Oviedo Spain Recruiting
Aydin University Hospital Istanbul Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06370182 on ClinicalTrials.gov ↗ ← All trials in the USA