Clinical trial NCT05409430: ANAIS Study to Confirm the Safety and Performance of the ANA 5F Advanced Neurovascular Access®
Official title: Prospective, Single-arm, Multi-center Study to Confirm the Safety and Performance of the ANA 5F Advanced Neurovascular Access®, in Combination With a Stent Retriever in Patients With Acute Ischemic Stroke (ANAIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: AIS
Lead sponsor: Anaconda Biomed S.L.
Sponsor class: INDUSTRY
First posted: 2022-06-08
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with Acute Ischemic Stroke (AIS), indicated for treatment with ANA 5F device in combination with Solitaire stent retriever, whose stroke is attributable to an occlusion of a large artery in the neurovasculature.
Primary purpose: TREATMENT

Brief summary: Prospective, single-arm, multi-center study to assess the safety and performance of the ANA 5F Advanced Neurovascular Access®, in combination with a stent retriever in patients with acute ischemic stroke.

Detailed description: ANA 5F Advanced Neurovascular Access®: distal access catheter system designed to assist in neurovascular procedures by facilitating the insertion and guidance of other devices (i.e. retrieval devices and intravascular catheters) and temporarily restricting blood flow at the target position.

The objective of this study is to confirm the safety and performance of the ANA 5F device to be used as a tool to facilitate the Solitaire stent retriever placement and provide temporary restriction of blood flow in stroke patients undergoing neurothrombectomy for an acute large vessel occlusion (LVO) treated 24 hours from symptom onset (last time the subject was seen well).

Population: Up to 30 Participants with Acute Ischemic Stroke (AIS), indicated for treatment with ANA 5F device in combination with Solitaire stent retriever, whose stroke is attributable to an occlusion of a large artery in the neurovasculature.

Eligibility criteria: Inclusion Criteria:

* Clinical

  1. Age ≥18 and ≤85 years.
  2. Informed consent obtained from subject or acceptable subject surrogate (i.e. 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 or 1.
  6. Treatable as soon as possible and at least within 24 hours of symptom onset, defined as point in time when the subject was last seen well (at baseline) (Treatment start is defined as access puncture).
  7. Subjects being either (1) eligible for, and received, IV tPA/TNK within 3 hours of symptom onset or (2) ineligible for IV tPA/TNK treatment.

     Neuro Imaging
  8. 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.
  9. For patients treated ≤ 6 hours:

     1. MRI criterion: volume of diffusion restriction visually assessed ≤50 mL

        OR
     2. CT criterion: Alberta Stroke program early CT score (ASPECTS) 6 to 10 on baseline CT.

     For patients treated 6 to 24 hours. Target Mismatch Profile on CT perfusion or MRI (ischemic core volume is \< 70 ml, mismatch ratio is \> 1.8 and mismatch volume is \> 15 ml)
  10. The subject is indicated for neurothrombectomy treatment with SOLITAIRE, by the Interventionalist.

Exclusion Criteria:

* Clinical

  1. Initially treated with a different thrombectomy device.
  2. Subject has suffered a stroke in the past 1 year.
  3. Occlusion (TICI 0 or TICI 1 flow) of the basilar or vertebral arteries.
  4. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
  5. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with antivitamin K, with INR \>3.0.
  6. Known baseline glucose of \<50 mg/dL or \>400 mg/dL.
  7. Severe, sustained hypertension (systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg).
  8. Serious, advanced, or terminal illness with anticipated life expectancy of less than 1 year.
  9. History of life-threatening allergy (more than rash) to contrast medium.
  10. Known renal insufficiency with creatinine ≥3 mg/dL or Glomerular Filtration Rate (GFR) \<30 mL/min.
  11. Cerebral vasculitis.
  12. Subject is a current user or has a recent history of cocaine use.
  13. Pregnant and/or lactating woman.
  14. Patient participating in a study involving an investigational drug or device that would impact this study.
  15. Patients that are unlikely to be available for a 90-day follow-up (e.g. no fixed home address, visitor from overseas).

      Neuro Imaging
  16. CT or MRI evidence of hemorrhage (the presence of microbleeds is allowed).
  17. Angiographic evidence of vasculitis.
  18. Significant mass effect with midline shift.
  19. Evidence of complete occlusion, high grade stenosis or arterial dissection in the extracranial or internal carotid artery (ICA).
  20. Subjects with known or suspected underlying intracranial atherosclerotic lesions responsible for the target occlusion.
  21. Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
  22. Evidence of intracranial tumor.
  23. Suspicion of aortic dissection presumed septic embolus, or suspicion of bacterial endocarditis.
  24. Severe arterial tortuosity likely to prevent stable positioning of the guide catheter in the distal cervical segment (C1) or petrous segment (C2) of internal carotid artery (ICA).

      Technical
  25. Inability to create an arterial access and / or to advance a guide catheter due to anatomical or physiological restrictions (i.e. vasospasm).
  26. Inability of the guide catheter to obtain a stable position in the ICA.

Primary outcomes:
measure: Successful reperfusion, defined as rate of patients achieving mTICI ≥2b.
timeFrame: Day0. Intraoperative
measure: The composite of symptomatic Intracranial Hemorrhage (sICH) within 24 hours (-8 / +12 h) post-procedure, together with serious adverse device effects.
timeFrame: 24 hours (-8 / +12 h) post-procedure
Secondary outcomes:
measure: Occurrence of Intracranial Hemorrhage (ICH); any symptomatic or asymptomatic ICH
timeFrame: 90 days
Other outcomes:
measure: Rate of subjects with a neurological deterioration of ≥4 points on NIHSS
timeFrame: 24 hours
measure: Occurrence of embolization in a previously uninvolved territory on the cerebral angiogram.
timeFrame: Day 0. Intraoperative
measure: Procedure-related mortality rate.
timeFrame: Day 5 (± 12 hours) or discharge, whichever comes first, and at 90 days.
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari de la Vall d'Hebron
city: Girona
country: Spain
facility: Hospital Universitari Dr. Josep Trueta
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
Study officials:
affiliation: Anaconda Biomed S.L.
name: René Spaargaren, MD
role: STUDY_CHAIR
References: