ANAIS Study to Confirm the Safety and Performance of the ANA 5F Advanced Neurovascular Access® (ANAIS)

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)

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.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: Neurothrombectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital Universitari de la Vall d'Hebron
  • Girona, Spain
    • Hospital Universitari Dr. Josep Trueta
  • Murcia, Spain
    • Hospital Clinico Universitario Virgen de la Arrixaca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with Acute Ischemic Stroke (AIS); 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.

Device: Neurothrombectomy; The ANA 5F device is intended to be inserted, be navigated to the neurovascular anatomy inside an outer catheter and be used as a conduit for insertion and guidance of intravascular catheters and retrieval devices into a selected blood vessel. The funnel is deployed by retracting the conduit catheter and is intended, when deployed, to provide temporary vascular flow restriction. The device is indicated for the introduction of interventional devices into the neuro vasculature, during interventions for restoring blood flow in patients experiencing acute ischemic stroke due to large vessel occlusion.; Other Names: Mechanical thrombectomy (MT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful reperfusion, defined as rate of patients achieving mTICI ≥2b.	Successful reperfusion, defined as rate of patients achieving mTICI ≥2b in the target vessel within three passes of the ANA 5F before the use of rescue therapy, assessed by the Core Lab.	Day0. Intraoperative
The composite of symptomatic Intracranial Hemorrhage (sICH) within 24 hours (-8 / +12 h) post-procedure, together with serious adverse device effects.	The composite of symptomatic Intracranial Hemorrhage (sICH) within 24 hours (-8 / +12 h) post-procedure, together with serious adverse device effects (excluding those already counted in sICH) at Day 5 (± 12 h) or discharge (whatever comes first).	24 hours (-8 / +12 h) post-procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of Intracranial Hemorrhage (ICH); any symptomatic or asymptomatic ICH	90 days

Other Outcome Measures

Outcome Measure	Time Frame
Rate of subjects with a neurological deterioration of ≥4 points on NIHSS	24 hours
Occurrence of embolization in a previously uninvolved territory on the cerebral angiogram.	Day 0. Intraoperative
Procedure-related mortality rate.	Day 5 (± 12 hours) or discharge, whichever comes first, and at 90 days.

Collaborators and Investigators

• Sponsor: Anaconda Biomed S.L.
• Investigators: Study Chair: René Spaargaren, MD, Anaconda Biomed S.L.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Actual): July 10, 2023
• Study Completion (Actual): July 10, 2023

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: June 3, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: AIS
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: ANA2201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No