Status:
TERMINATED
Assessing Safety and Performance of the ANA Catheter System, Combined With a Stent Retriever in Acute Ischemic Stroke
Lead Sponsor:
Anaconda Biomed S.L.
Conditions:
Stroke, Ischemic
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The ANA catheter system (may also be designated as "ANA system", "ANA 18 -002" or "ANA device") is a distal access catheter designed to assist in neurovascular procedures by facilitating the insertion...
Eligibility Criteria
Inclusion
- Clinical
- Age ≥18 and ≤85 years.
- Informed consent obtained from subject or acceptable subject surrogate (i.e. next of kin, or legal representative).
- A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
- Baseline NIHSS obtained prior to procedure ≥ 8 points and ≤ 25 points.
- Pre-ictal mRS score of 0 or 1.
- Treatable as soon as possible and at least within 8 h of symptom onset, defined as point in time when the subject was last seen well (at baseline). (Treatment start is defined as groin puncture.)
- Subjects for whom intravenous (IV) tissue plasminogen activator (t PA) is indicated and who are available for treatment, are treated with IV t-PA. For such patients, IV t-PA should be administered as recommended by the American Heart Association/American Stroke Association (AHA/ASA) Guidelines for the early management of patients with AIS.
- IV t-PA, if used, is initiated as soon as possible and within 3 h of stroke onset (onset time is defined as the last time when the patient was witnessed to be well at baseline), with investigator verification that the subject has received/is receiving the correct IV t-PA dose for the estimated weight.
- Neuro Imaging
- Occlusion (TICI 0 or TICI 1 flow), of the terminal internal carotid artery, M1 or M2 segments of the middle cerebral artery, suitable for mechanical embolectomy, confirmed on conventional angiography.
- The following imaging criteria should also be met:
- MRI criterion: volume of diffusion restriction visually assessed ≤50 mL. OR
- CT criterion: Alberta Stroke program early CT score (ASPECTS) 6 to 10 on baseline CT or CT-Angiography (CTA)-source images, or, volume of significantly lowered Cerebral Blood Volume (CBV) ≤50 mL.
- The subject is indicated for neurothrombectomy treatment by the Interventionalist.
Exclusion
- Clinical
- Pre-stroke functional disability (mRS score \>1).
- Initially treated with a different thrombectomy device.
- Subject has suffered a stroke in the past 1 year.
- Occlusion (TICI 0 or TICI 1 flow) of the basilar or vertebral arteries
- The subject presents with an NIHSS score \<8 or \>25.
- Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
- Severe arterial tortuosities avoiding stable positioning of the guide catheter in the petrous segment (C2) of Internal Carotid Artery (ICA)
- Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \>3.0.
- Baseline platelet count \<50,000/µL.
- Baseline blood glucose of \<50 mg/dL or \>400 mg/dL.
- Severe, sustained hypertension (systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg).
- NOTE: If the blood pressure can be successfully reduced and maintained at an acceptable level using European Stroke Organisation (ESO) guidelines recommended medication (including IV antihypertensive drips), the patient can be enrolled.
- Serious, advanced, or terminal illness with anticipated life expectancy of less than 1 year.
- Subjects with identifiable intracranial tumors.
- History of life-threatening allergy (more than rash) to contrast medium.
- Known nickel allergy at time of treatment.
- Known renal insufficiency with creatinine ≥3 mg/dL or Glomerular Filtration Rate (GFR) \<30 mL/min.
- Cerebral vasculitis.
- Evidence of active systemic infection.
- Known current use of cocaine at time of treatment.
- Woman of childbearing potential who is known to be pregnant, and/or lactating, or who has a positive pregnancy test on admission.
- Patient participating in a study involving an investigational drug or device that would impact this study.
- Patients that are unlikely to be available for a 90-day follow-up (e.g. no fixed home address, visitor from overseas).
- Neuro Imaging
- Hypodensity on CT or restricted diffusion amounting to an Alberta Stroke Program Early CT (ASPECTS) score of \<6 on CT or \<5 on diffusion weighted (DW) MRI.
- CT or MRI evidence of hemorrhage (the presence of microbleeds is allowed).
- Angiographic evidence of carotid dissection, high grade stenosis or vasculitis.
- Significant mass effect with midline shift.
- Evidence of complete occlusion, high grade stenosis or arterial dissection in the extracranial or petrous segment of the internal carotid artery.
- Subjects with known or suspected underlying intracranial atherosclerotic lesions responsible for the target occlusion.
- Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
- Evidence of intracranial tumor.
- Suspicion of aortic dissection presumed septic embolus, or suspicion of bacterial endocarditis.
Key Trial Info
Start Date :
September 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2021
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04095767
Start Date
September 21 2019
End Date
June 15 2021
Last Update
July 2 2021
Active Locations (9)
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1
Hospital Germans Trias
Badalona, Catalonia, Spain, 08916
2
Hospital Universitario Cruces
Bilbao, Vizcaya, Spain, 48903
3
Hospital Vall d'Hebron
Barcelona, Spain, 08035
4
Hospital Clínic de Barcelona
Barcelona, Spain, 08036