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

NCT05409430 | Completed DMC

• 1 other identifier: ANA2201
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Ischemic Stroke

Keywords

AIS

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Occurrence of Intracranial Hemorrhage (ICH); any symptomatic or asymptomatic ICH

  90 days

Other Outcomes (3)

• 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.

Study Arms (1)

Patients with Acute Ischemic Stroke (AIS)

EXPERIMENTAL

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

Interventions

Neurothrombectomy DEVICE

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.

Also known as: Mechanical thrombectomy (MT)

Patients with Acute Ischemic Stroke (AIS)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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).
• 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
• 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.
• For patients treated ≤ 6 hours:
• MRI criterion: volume of diffusion restriction visually assessed ≤50 mL
• 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)
• The subject is indicated for neurothrombectomy treatment with SOLITAIRE, by the Interventionalist.

You may not qualify if:

• Clinical
• 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.
• Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
• Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with antivitamin K, with INR \>3.0.
• Known baseline glucose of \<50 mg/dL or \>400 mg/dL.
• Severe, sustained hypertension (systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg).
• Serious, advanced, or terminal illness with anticipated life expectancy of less than 1 year.
• History of life-threatening allergy (more than rash) to contrast medium.
• Known renal insufficiency with creatinine ≥3 mg/dL or Glomerular Filtration Rate (GFR) \<30 mL/min.
• Cerebral vasculitis.
• Subject is a current user or has a recent history of cocaine use.
• Pregnant and/or lactating woman.
• Patient participating in a study involving an investigational drug or device that would impact this study.

Sponsors & Collaborators

• Anaconda Biomed S.L.: lead

Study Sites (3)

Hospital Universitari de la Vall d'Hebron

Barcelona, Spain

Location

Hospital Universitari Dr. Josep Trueta

Girona, Spain

Location

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Spain

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• René Spaargaren, MD

  Anaconda Biomed S.L.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 8, 2022
• Study Start: May 9, 2022
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

ES (3)