RECRUITING

Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA5 Device

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-09-09

Study Completion:2027-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06370182

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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 * 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.	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.

Inclusion Criteria

Exclusion Criteria

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
* 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.

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.

Contacts and Locations

Study Contact

Hendrik Lambert

CONTACT

(404) 277-7280

athena@anaconda.bio

Tina Cordaro

CONTACT

athena@anaconda.bio

Principal Investigator

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

Study Locations (Sites)

Baptist Health Medical Center

Jacksonville, Florida, 32207

United States

Grady Memorial Hospital, Emory

Atlanta, Georgia, 30322

United States

Advocate Health

Park Ridge, Illinois, 60068

United States

University of Iowa

Iowa City, Iowa, 52242

United States

Boston Medical Center

Boston, Massachusetts, 02118

United States

University of Buffalo Neurosurgery

Buffalo, New York, 14203

United States

Mount Sinai Hospital

New York, New York, 10029

United States

Oregon Health & Science University

Portland, Oregon, 97239

United States

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, 15213

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215

United States

Collaborators and Investigators

Sponsor: Anaconda Biomed S.L.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-09

Study Completion Date2027-05

Study Record Updates

Study Start Date2024-09-09

Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

flow arrest
flow restriction
funnel
guide catheter
mechanical thrombectomy

Additional Relevant MeSH Terms

Acute Ischemic Stroke From Large Vessel Occlusion