Assessing Safety and Performance of the ANA Catheter System, Combined With a Stent Retriever in Acute Ischemic Stroke

NCT04095767 | Terminated DMC

• 1 other identifier: AN04080
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 9

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 and guiding of other devices (i.e. retrieval devices and intravascular catheters) and restricting blood flow at the target position. It is a sterile, single-use, disposable intravascular device comprised of two coaxial catheters (delivery catheter and funnel catheter) consisting of sections of variable stiffness. The funnel catheter is comprised of a radiopaque nitinol braid (self-expanding funnel), covered by a continuous silicone coating that, when deployed, provides local and temporary flow restriction. The delivery catheter has a hydrophilic coating to reduce friction during use and a radiopaque marker on the distal end. Both catheters have Luer lock hubs on their proximal end. The proposed study has been designed to collect prospective clinical evidence to compare the Anaconda ANA device to similar devices used for guiding and supporting stent retrievers during neurothrombectomy procedures. The protocol has been designed to replicate the patient population enrolled in prior studies of similar devices. The primary endpoint will be ability of the investigational device to facilitate stentriever deployment and neurothrombectomy in the anterior circulation, with successful reperfusion defined as achieving a modified Thrombolysis in Cerebral Infarction (mTICI) score of ≥2b in the target vessel with ≤3 passes of the investigational device without the use of rescue therapy. Follow-up at 24h, Day 5 (+/- 12 h) or discharge, whichever comes first and at 90 days will allow documentation of the clinical outcome of the neurothrombectomy procedure as a whole and detect any device related and other complications, making use of the ANA device for distal access.

Conditions

Stroke, Ischemic

Keywords

Thrombectomy

Outcome Measures

Primary Outcomes (2)

• modified Thrombolysis in Cerebral Infarction (mTICI) score

  The ability of the investigational device to facilitate stentriever deployment and to perform neurothrombectomy in the anterior circulation, with successful reperfusion defined as achieving a modified Thrombolysis in Cerebral Infarction (mTICI) score of ≥2b in the target vessel with ≤3 passes of the investigational device without the use of rescue therapy.

  At end of neurothrombectomy

• Occurrence of serious Adverse Device Effects

  The occurrence of all serious adverse device effects up to 90-days post-procedure, including symptomatic IntraCerebral Hemorrhage (sICH) at 24h (-8/+12 h).

  Up to 90 days

Study Arms (1)

Treatment arm

EXPERIMENTAL

The thrombectomy in eligible patients will be carried out by making use of the device under investigation.

Device: Neurothrombectomy

Interventions

Neurothrombectomy DEVICE

Intra-arterial recanalization therapy or mechanical thrombectomy (MT) is a therapeutic option for patients who are not candidates for t-PA or in whom t-PA has failed. MT is performed by means of various devices (Merci Revive, Penumbra, etc.). There are currently two major approaches to MT: the so-called stent retrievers (used with or without a balloon catheter), and catheters used for direct aspiration (manual with syringe or by aspiration pump via distal access catheters \[DACs\]). Moreover, both techniques can be combined. MT may be performed following IV t-PA, as a stand alone therapy, or in conjunction with IA thrombolysis.

Treatment arm

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anaconda Biomed S.L.: lead

Study Sites (9)

Hospital Germans Trias

Badalona, Catalonia, 08916, Spain

Location

Hospital Universitario Cruces

Bilbao, Vizcaya, 48903, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Clínico San Carlos Madrid

Madrid, 28040, Spain

Location

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Hospital Central de Asturias

Oviedo, 33011, Spain

Location

Related Publications (1)

• Requena M, Ribo M, Zamarro J, Vega P, Blasco J, Gonzalez EM, Del Mar Freijo M, Mendez Cendon JC, de Miquel MA, Hernandez D, Moreu M, Remollo S, Sanchez S, Liebeskind DS, Andersson T, Cognard C, Nogueira R, Tomasello A. Clinical Results of the Advanced Neurovascular Access Catheter System Combined With a Stent Retriever in Acute Ischemic Stroke (SOLONDA). Stroke. 2022 Jul;53(7):2211-2219. doi: 10.1161/STROKEAHA.121.037577. Epub 2022 Apr 1.

  PMID: 35360928 DERIVED

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 SL

  STUDY DIRECTOR

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: Prospective, single-arm, multi-center, study

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 19, 2019
• Study Start: September 21, 2019
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: July 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (9)