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NCT06370182 | RECRUITING | Acute Ischemic Stroke From Large Vessel Occlusion

Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA5 Device
Sponsor:

Anaconda Biomed S.L.

Brief 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.

Condition or disease

Acute Ischemic Stroke From Large Vessel Occlusion

Intervention/treatment

ANA Funnel Catheter

Control

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 327 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : A Prospective, Randomized, Dual-arm Multi-center Study to Assess the Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA5 Device in Combination With a Stent Retriever
Actual Study Start Date : 2024-09-09
Estimated Primary Completion Date : 2027-02
Estimated Study Completion Date : 2027-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 22 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 ≥ 8 points and ≤ 25 points.
  • 5. Pre-ictal mRS score of 0,1 or 2.
  • 6. Treatable within 24 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.
    • 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.
Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA5 Device

Location Details

NCT06370182

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Baptist Health Medical Center

Jacksonville, Florida, United States, 32207

RECRUITING

United States, Georgia

Grady Memorial Hospital, Emory

Atlanta, Georgia, United States, 30322

RECRUITING

United States, Illinois

Advocate Health

Park Ridge, Illinois, United States, 60068

RECRUITING

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 52242

RECRUITING

United States, Massachusetts

Boston Medical Center

Boston, Massachusetts, United States, 02118

RECRUITING

United States, New York

University of Buffalo Neurosurgery

Buffalo, New York, United States, 14203

RECRUITING

United States, New York

Mount Sinai Hospital

New York, New York, United States, 10029

RECRUITING

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

RECRUITING

United States, Pennsylvania

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, United States, 15213

RECRUITING

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

RECRUITING

United States, Wisconsin

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States, 53215

RECRUITING

France,

Montpellier University Hospital Center

Montpellier, France, 34295

RECRUITING

France,

Fondation Rothschild

Paris, France, 75019

RECRUITING

France,

Hospital Foch

Suresnes, France, 92150

RECRUITING

France,

Toulouse University Hospital Center

Toulouse, France, 40031

RECRUITING

Hungary,

Semmelweis University Hospital

Budapest, Hungary, 1145

RECRUITING

Spain,

Vall d'Hebron University Hospital

Barcelona, Spain, 08035

RECRUITING

Spain,

Clinic Hospital in Barcelona

Barcelona, Spain, 08036

RECRUITING

Spain,

San Carlos Clinic Hospital

Madrid, Spain, 28040

RECRUITING

Spain,

Virgen de la Arrixaca Hospital

Murcia, Spain, 30120

RECRUITING

Spain,

Central University Hospital of Asturias

Oviedo, Spain, 33011

RECRUITING

Turkey (Türkiye),

Aydin University Hospital

Istanbul, Turkey (Türkiye), 34295