Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA5 Device

Launched by ANACONDA BIOMED S.L. · Apr 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Anaconda ANA5, which is used in a procedure called mechanical thrombectomy to help treat people who have had an acute ischemic stroke. This type of stroke happens when a large blood vessel in the brain gets blocked, preventing blood flow. The aim of the trial is to see how safe and effective this device is when used within 24 hours of the stroke symptoms starting. It helps doctors place other tools needed during the procedure to remove the blockage.

To be eligible for this trial, participants need to be experiencing a new, serious problem with their ability to move or speak due to the stroke, with a specific level of severity on a stroke scale. They also need to be treated within 24 hours of when they were last symptom-free. Some people may not qualify if they have a history of stroke in the past year, certain types of high blood pressure, or other specific medical conditions. Those who join can expect to receive care from a team of healthcare professionals and contribute to research that may help improve stroke treatment for future patients.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
• • 2. Baseline National Institutes of Health Stroke Scale (NIHSS) obtained prior to procedure ≥ 8 points and ≤ 25 points.
• • 3. Pre-ictal modified Rankin Score (mRS) score of 0,1 or 2.
• • 4. 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.
• • 5. 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.
• • 6. 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.
• Key Exclusion Criteria:
• • 1. Subject was diagnosed with a stroke in the past year.
• • 2. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
• • 3. Severe, sustained uncontrolled hypertension refractory to treatment (systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg).
• • 4. Known pregnancy and/or lactating female.
• • 5. CT or MRI evidence of hemorrhage (the presence of microbleeds is allowed).
• • 6. Significant mass effect with midline shift.
• • 7. Evidence of intracranial tumor (except small meningioma).
• • 8. History of preexisting stent proximal to or at the occlusion site that may preclude safe deployment or recovery of the stent retriever.
• • 9. 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.
• • 10. Evidence of tandem lesions, including complete occlusion, high grade stenosis or arterial dissection in the extracranial or internal carotid artery (ICA), requiring treatment or preventing access to thrombus.
• • 11. Subjects with known or suspected underlying intracranial atherosclerotic lesions responsible for the target occlusion.
• • 12. Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
• • 13. Anatomical or physiological restrictions (e.g., severe stenosis, vasospasm, high tortuosity, etc.) detected via angiogram likely to result in an inability to position the guide catheter or to deploy the ANA or intermediate catheter in the targeted ICA segment with acceptable vessel diameter as defined in the Instructions for Use.