Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA Funnel Catheter
NCT ID: NCT06370182
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
327 participants
INTERVENTIONAL
2024-09-09
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ANA Funnel Catheter Group
Mechanical thrombectomy using a stent retriever delivered by the ANA device.
ANA Funnel Catheter
Mechanical thrombectomy using a stent retriever delivered by the ANA device that enables local flow restriction when deployed.
Control Group
Mechanical thrombectomy using a stent retriever delivered by an approved guide catheter.
Control
Mechanical thrombectomy using a stent retriever delivered by an approved guide catheter with or without an intermediate catheter and aspiration per conventional techniques.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
22 Years
85 Years
ALL
No
Sponsors
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Anaconda Biomed S.L.
INDUSTRY
Responsible Party
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Principal Investigators
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Adnan Siddiqui, MD, PhD, FAHA
Role: PRINCIPAL_INVESTIGATOR
Jacobs School of Medicine & Biomedical Sciences
Santiago Ortega-Gutierrez, MD, MSc, FAHA, FSVIN
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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Baptist Health Medical Center
Jacksonville, Florida, United States
Grady Memorial Hospital, Emory
Atlanta, Georgia, United States
Advocate Health
Park Ridge, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Boston Medical Center
Boston, Massachusetts, United States
University of Buffalo Neurosurgery
Buffalo, New York, United States
Mount Sinai Hospital
New York, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Centre Hospitalier Universitaire de Montpellier
Montpellier, , France
Fondation Rothschild
Paris, , France
Hospital Foch
Suresnes, , France
Centre Hospitalier Universitaire de Toulouse
Toulouse, , France
Semmelweis University Hospital
Budapest, , Hungary
Hospital Universitario Vall D'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Virgen de la Arrixaca
Murcia, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Aydin University Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Role: primary
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Other Identifiers
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ANA2401
Identifier Type: -
Identifier Source: org_study_id
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