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Acute Ischemic StrokeNCT05139147

DAISe 1 Feasibility Study to Evaluate the DAISe Thrombectomy System for Acute Ischemic Stroke

A study testing DAISe Thrombectomy System in people with Acute Ischemic Stroke, run by MIVI Neuroscience, Inc. at 6 sites in France.

Terminated

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

Official record
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Trial summary

The study is a prospective, multi-center, single arm, feasibility study that will enroll a maximum of 36 subjects. The maximum enrollment is 10 subjects per site. A maximum of 6 investigational centers in Europe will participate. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
DAISe Thrombectomy System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
6 sitesFrance
Study dates
12 Jan 2022to 4 Aug 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years or older.
  • Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Rankin Score 0-1. Patient must be living in their own home, apartment or seniors lodge where no nursing care is required.
  • Diagnosis of acute ischemic stroke and referred to interventional neuroradiology center for mechanical thrombectomy with study enrollment time planned within 8 hours from onset of symptoms.
  • Disabling stroke defined as a baseline NIHSS > 6.
  • Thrombolytic therapy (IV tPA) received within 4.5 hours of onset/ last known well according to prescribed dosing OR documented ineligibility for thrombolytic therapy.
  • Confirmed symptomatic, large vessel occlusion of the intracranial internal carotid artery, middle cerebral artery, M1, or M2 with mTICI 0-1.
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  • The following baseline imaging criteria should be met: MRI criterion- volume of diffusion restriction visually assessed ≤50 mL OR ASPECTs score 5-10 or T criterion- ASPECTS 6-10 on imaging NE-CT, CTA and/or CTP available
  • Signed informed consent from patient or legal representative or if applicable, documented medical necessity for inclusion in a clinical study in an emergency followed by signed informed consent.
  • Patient is affiliated in the social security system.

Who cannot join

  • Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
  • Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic.
  • Rapidly improving neurological deficits based on the investigator's clinical judgement.
  • Pregnancy; if a woman is of child-bearing potential and urine or serum beta HCG test is positive.
  • Severe contrast allergy or absolute contraindication to iodinated contrast.
  • Renal failure (serum creatinine level ≥ 3 mg/dL or on dialysis).
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  • Severe, sustained hypertension resistant to treatment (SBP >185 mmHg or DBP >110 mmHg).
  • Use of warfarin anticoagulation (or other applicable anti-vitamin k anticoagulants) with International Normalized Ratio (INR) > 3.0 at the time of the procedure or any known hemorrhagic or coagulation deficiency.
  • Use of a direct thrombin inhibitor within the last 48 hours; partial thromboplastin time (PTT) > 2.0 times the normal prior to procedure.
  • Cerebral vasculitis or evidence of active systemic infection.
  • Suspicion of aortic dissection, presumed septic embolus or suspicion of bacterial endocarditis.
  • Clinical symptoms suggestive of bilateral stroke or occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
  • Seizure due to stroke.
  • Difficult endovascular access, difficult aortic arch or severe neurovascular tortuosity that will result in an inability to deliver endovascular therapy.
  • Evidence of dissection in the carotid or target artery for treatment.
  • Presence of a carotid artery stenosis or occlusion requiring balloon angioplasty or stenting at time of the procedure.
  • A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
  • Patient cannot undergo an MRI of the head due to MRI contraindication.
  • Patient is unable or unwilling complete follow up visits.
  • If before the stroke, the patient is under a legal protective measure, they will not be able to participate in the study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • CHU Pellegrin

    Bordeaux, 33000

  • CHU Montpellier

    Montpellier

  • CHU Urbains

    Nancy, 54035

  • CHU Bicetre Paris

    Paris, 94270

  • Groupe Hospitalier Pitie-Salpetriere

    Paris

  • Hôpital Purpan

    Toulouse, 31059

Other trials in France

About this study

Official title: A Prospective, Multi-Center, Single Arm, Feasibility Study to Evaluate the DAISe Thrombectomy System During Neurointervention for Acute Ischemic Stroke; DAISe 1 Study

The study is a prospective, multi-center, single arm, feasibility study that will enroll a maximum of 36 subjects. The maximum enrollment is 10 subjects per site. A maximum of 6 investigational centers in Europe will participate. Enrollment is expected to take about 9 months, subject participation will last about 3 months.

Being tested
DAISe Thrombectomy System
Medical subject headings
Ischemic Stroke

What participants receive

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

  • DAISe Thrombectomy SystemDevice

    DAISe Thrombectomy System for mechanical thrombectomy

Study groups in NCT05139147
Study groupRoleWhat they receive
DAISe Thrombectomy SystemExperimentalMechanical thrombectomy utilizing the DAISe Thrombectomy System, consisting of the DAISe Thrombectomy Device and DAISe Delivery Catheter, used with aspiration.
Receives: Device: DAISe Thrombectomy System

What is being measured

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

  1. Rate of first pass revascularization success

    First pass successful revascularization defined as mTICI (modified Treatment in Cerebral Ischemia) 2b-3 flow in the target vessel post-treatment with the DAISe Thrombectomy System used with aspiration.

    Measured: procedure

  2. Rate of symptomatic intracranial hemorrhage

    Symptomatic intracranial haemorrhage at 24 (+/-12) hours post-procedure as detected by CT/MRI with clinical deterioration of an NIHSS change of greater than or equal to 4

    Measured: 12-36 hours

Secondary outcomes (12)

  1. Rate of successful revascularization with the DAISe Device

    Successful revascularization of mTICI 2c-3 as a result of the first attempt with the DAISe Thrombectomy Device

    Measured: Procedure

  2. Rate of procedural final successful revascularization

    Successful revascularization of final mTICI 2b-3 at the end of the procedure

    Measured: Procedure

  3. Rate of successful revascularization at procedure end

    Successful revascularization of final mTICI 2c-3 at the end of the procedure

    Measured: Procedure

  4. Rate of successful device use

    Measured by the successful delivery and placement of the DAISe Device in the target artery

    Measured: Procedure

  5. Procedure time

    Time from groin puncture to successful revascularization defined as final mTICI 2b-3 flow

    Measured: Procedure

  6. Complications

    Rate of procedure and/or device related complications

    Measured: Procedure

  7. Rate of ENT

    Rate of embolization to a new vascular territory (ENT) during procedure

    Measured: Procedure

  8. Infarct volume

    Infarct volume in MRI (FLAIR/Diffusion Weighted Imaging [DWI] combined)

    Measured: 12-36 hours

  9. Emboli

    Number of emboli outside of main infarct affected territory and outside the affected territory in high-resolution DWI

    Measured: 12-36 hours

  10. Intracranial hemorrhage

    Occurrence of all intracranial hemorrhage using the Heidelberg Bleeding Classification

    Measured: 12-36 hours

  11. Good functional outcome

    Good functional outcome measured by Modified Rankin Score (measured 0 completely functional to 6 deceased) of 0-2

    Measured: 3 months

  12. Mortality Rate

    All cause mortality

    Measured: 3 months

Timeline

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

  1. First posted1 Dec 2021
  2. Study start12 Jan 2022
  3. Primary completion20 Jul 2023
  4. Study completion4 Aug 2023

Why it stopped: Enrollment/Recruitment

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
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05139147
Sponsor's protocol ID
101995
Status last verified
Aug 2024
First submitted
9 Nov 2021
Last updated
9 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing DAISe Thrombectomy System in people with Acute Ischemic Stroke, run by MIVI Neuroscience, Inc. at 6 sites in France.

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 9 inclusion and 20 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 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. 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: Enrollment/Recruitment). 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?

Rate of first pass revascularization success (time frame: procedure). 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 NCT05139147.

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 9 Aug 2024.

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Clinical Trial NCT05139147 | AzTrials