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Trial record 1 of 1 for:    NCT04095767
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Assessing Safety and Performance of the ANA Catheter System, Combined With a Stent Retriever in Acute Ischemic Stroke (SOLONDA)

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ClinicalTrials.gov Identifier: NCT04095767
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
MedPass International
UCLA Department of Neurology
Information provided by (Responsible Party):
Anaconda Biomed S.L.

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.


Condition or disease Intervention/treatment Phase
Stroke, Ischemic Device: Neurothrombectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, single-arm, multi-center, study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 21, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Treatment arm
The thrombectomy in eligible patients will be carried out by making use of the device under investigation.
Device: Neurothrombectomy
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.




Primary Outcome Measures :
  1. modified Thrombolysis in Cerebral Infarction (mTICI) score [ Time Frame: At end of neurothrombectomy ]
    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.

  2. Occurrence of serious Adverse Device Effects [ Time Frame: Up to 90 days ]
    The occurrence of all serious adverse device effects up to 90-days post-procedure, including symptomatic IntraCerebral Hemorrhage (sICH) at 24h (-8/+12 h).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.)
    7. 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.
    8. 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

    9. 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.
    10. The following imaging criteria should also be met:

      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 or CT-Angiography (CTA)-source images, or, volume of significantly lowered Cerebral Blood Volume (CBV) ≤50 mL.
    11. The subject is indicated for neurothrombectomy treatment by the Interventionalist.

Exclusion Criteria:

  • Clinical

    1. Pre-stroke functional disability (mRS score >1).
    2. Initially treated with a different thrombectomy device.
    3. Subject has suffered a stroke in the past 1 year.
    4. Occlusion (TICI 0 or TICI 1 flow) of the basilar or vertebral arteries
    5. The subject presents with an NIHSS score <8 or >25.
    6. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
    7. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR >3.0.
    8. Baseline platelet count <50,000/µL.
    9. Baseline blood glucose of <50 mg/dL or >400 mg/dL.
    10. 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.

    11. Serious, advanced, or terminal illness with anticipated life expectancy of less than 1 year.
    12. Subjects with identifiable intracranial tumors.
    13. History of life-threatening allergy (more than rash) to contrast medium.
    14. Known nickel allergy at time of treatment.
    15. Known renal insufficiency with creatinine ≥3 mg/dL or Glomerular Filtration Rate (GFR) <30 mL/min.
    16. Cerebral vasculitis.
    17. Evidence of active systemic infection.
    18. Known current use of cocaine at time of treatment.
    19. Woman of childbearing potential who is known to be pregnant, and/or lactating, or who has a positive pregnancy test on admission.
    20. Patient participating in a study involving an investigational drug or device that would impact this study.
    21. Patients that are unlikely to be available for a 90-day follow-up (e.g. no fixed home address, visitor from overseas).

      Neuro Imaging

    22. 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.
    23. CT or MRI evidence of hemorrhage (the presence of microbleeds is allowed).
    24. Angiographic evidence of carotid dissection, high grade stenosis or vasculitis.
    25. Significant mass effect with midline shift.
    26. Evidence of complete occlusion, high grade stenosis or arterial dissection in the extracranial or petrous segment of the internal carotid artery.
    27. Subjects with known or suspected underlying intracranial atherosclerotic lesions responsible for the target occlusion.
    28. Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
    29. Evidence of intracranial tumor.
    30. Suspicion of aortic dissection presumed septic embolus, or suspicion of bacterial endocarditis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04095767


Contacts
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Contact: Lieven Huysse, MD +34637274236 clinical@anaconda.bio

Locations
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Spain
Hospital Germans Trias Recruiting
Badalona, Catalunya, Spain, 08916
Contact: Sebastià Remollo, MD    +34932746000      
Hospital Universitario Cruces Recruiting
Bilbao, Vizcaya, Spain, 48903
Contact: Marimar Freijo, MD    +34946006000      
Contact: Eva M González, MD    +34946006000      
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Alejandro Tomasello, MD         
Hospital Clínic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Jordi Blasco, MD         
Hospital Universitari de Bellvitge Recruiting
Barcelona, Spain, 08907
Contact: Maria Angeles de Miquel Miquel, MD         
Sponsors and Collaborators
Anaconda Biomed S.L.
MedPass International
UCLA Department of Neurology
Investigators
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Study Director: Lieven Huysse, MD Anaconda Biomed SL

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Responsible Party: Anaconda Biomed S.L.
ClinicalTrials.gov Identifier: NCT04095767    
Other Study ID Numbers: AN04080
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anaconda Biomed S.L.:
Thrombectomy
Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes