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Stroke, IschemicSOLONDANCT04095767

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

A study testing Neurothrombectomy in people with Stroke, Ischemic, run by Anaconda Biomed S.L. at 9 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Stroke, Ischemic
What is being tested?
Neurothrombectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
9 sitesSpain
Study dates
21 Sep 2019to 15 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Spain9 sites

  • Hospital Germans Trias

    Badalona, Catalonia, 08916

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital Universitari de Bellvitge

    Barcelona, 08907

  • Hospital Universitario Cruces

    Bilbao, Vizcaya, 48903

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Clínico San Carlos Madrid

    Madrid, 28040

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, 30120

  • Hospital Central de Asturias

    Oviedo, 33011

Other trials in Spain

About this study

Official title: Prospective, Single-Arm, Multi-center Study to Assess the Safety and Performance of the ANA Catheter System, in Combination With a Stent Retriever in Patients With Acute Ischemic Stroke

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.

Being tested
Neurothrombectomy
Keywords
Thrombectomy
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeurothrombectomyDevice

    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.

Study groups in NCT04095767
Study groupRoleWhat they receive
Treatment armExperimentalThe thrombectomy in eligible patients will be carried out by making use of the device under investigation.
Receives: Device: Neurothrombectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At end of neurothrombectomy

  2. 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).

    Measured: Up to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2019
  2. Study start21 Sep 2019
  3. Primary completion15 Jun 2021
  4. Study completion15 Jun 2021

Why it stopped: Primary efficacy endpoint achieved

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective, single-arm, multi-center, study
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04095767
Sponsor's protocol ID
AN04080
Acronym
SOLONDA
Status last verified
Jun 2021
First submitted
16 Sep 2019
Last updated
2 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35360928

Questions about this trial

What is this clinical trial studying?

A study testing Neurothrombectomy in people with Stroke, Ischemic, run by Anaconda Biomed S.L. at 9 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Primary efficacy endpoint achieved). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

modified Thrombolysis in Cerebral Infarction (mTICI) score (time frame: At end of neurothrombectomy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04095767, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.

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