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TerminatedNCT05631483COFEEUpdated Aug 9, 2024

COlombia DAISe FEasibility Exercise

An interventional study of DAISe in Stroke, Acute Ischemic, sponsored by MIVI Neuroscience, Inc.. Terminated at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-09.

Sponsored by MIVI Neuroscience, Inc. · Not applicable, Interventional, and Treatment

Why this study was terminated
Enrollment/Recruitment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jun 2022, registered Oct 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study is to assess initial safety and performance data of the DAISe Thrombectomy Device for removal of thrombus during an acute ischemic stroke.

02

Conditions studied

  • Stroke, Acute Ischemic

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03

In context

Ischemic Stroke

2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.

This study's enrollment of 2 is below the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

MIVI Neuroscience, Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 0-2.
  • Diagnosis of acute ischemic stroke with study enrollment time \< 8 hours from onset of symptoms.
  • Disabling stroke defined as a baseline NIHSS > 6.
  • Confirmed symptomatic, large vessel occlusion of the intracranial internal carotid artery, middle cerebral artery, M1.
  • Signed informed consent from patient or legal representative.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
  • Renal failure (serum creatinine level ≥ 3 mg/dL or on dialysis).
  • Severe, sustained hypertension resistant to treatment (SBP >185 mmHg or DBP>110 mmHg).
  • Use of warfarin anticoagulation 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).
  • A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    DAISe

    DAISe Thrombectomy Device

    Device: DAISe

Interventions

  • DeviceDAISe

    Use of the DAISe Thrombectomy Device

06

What researchers measure

Primary outcomes

  1. Rate of Successful Revascularization

    mTICI (Modified TICI) 2b-3 of the target vessel post-treatment with the DAISe Thrombectomy Device

    Time frame: Procedure

  2. Rate of Symptomatic Intracranial Hemorrhage

    Time frame: 24 hours post-procedure

Secondary outcomes

  1. Rate of Procedure related Complications

    Time frame: Through 90 day post-procedure

  2. Occurrence of all intracranial hemorrhage

    Time frame: 24 hours post-procedure

  3. All-cause mortality

    Time frame: Through Acute Hospital Discharge

  4. Embolization to a New Vascular Territory

    Time frame: Procedure

  5. Successful Revascularization after first attempt with DAISe

    mTICI (modified TICI) 2b-3 after first pass with device

    Time frame: Procedure

  6. Successful Revascularization after first attempt with DAISe

    mTICI (modified TICI) 2c-3 after first pass with device

    Time frame: Procedure

  7. Successful Revascularization at end of procedure

    mTICI (modified TICI) 2b-3 at the end of procedure

    Time frame: Procedure

  8. Successful Revascularization at end of procedure

    mTICI (modified TICI) 2c-3 at the end of procedure

    Time frame: Procedure

07

Study locations

1 site
  • Angiosur - Unidad Vascular Integral
    Itagüí, Antioquia, Colombia
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2022 to primary completion in Apr 2023, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2022
First posted
Nov 30, 2022
StartActual
Jun 14, 2022
Primary completionActual
Apr 26, 2023
CompletionActual
Aug 2, 2023
Last update
Aug 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05631483
Lead sponsor
MIVI Neuroscience, Inc.
Responsible party
Sponsor
First posted
Nov 30, 2022
Start date
Jun 14, 2022
Primary completion
Apr 26, 2023
Completion
Aug 2, 2023
Last update
Aug 9, 2024

Study contacts

Boris Pabon, MD
principal investigator · Angiosur

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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