Clinical trial NCT05631483: COlombia DAISe FEasibility Exercise
Official title: A Feasibility Study for the DAISe Thrombectomy Device in Colombia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke, Acute Ischemic
Lead sponsor: MIVI Neuroscience, Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-30
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Rate of Successful Revascularization
timeFrame: Procedure
measure: Rate of Symptomatic Intracranial Hemorrhage
timeFrame: 24 hours post-procedure
Secondary outcomes:
measure: Rate of Procedure related Complications
timeFrame: Through 90 day post-procedure
measure: Occurrence of all intracranial hemorrhage
timeFrame: 24 hours post-procedure
measure: All-cause mortality
timeFrame: Through Acute Hospital Discharge
measure: Embolization to a New Vascular Territory
timeFrame: Procedure
measure: Successful Revascularization after first attempt with DAISe
timeFrame: Procedure
measure: Successful Revascularization after first attempt with DAISe
timeFrame: Procedure
measure: Successful Revascularization at end of procedure
timeFrame: Procedure
measure: Successful Revascularization at end of procedure
timeFrame: Procedure
Other outcomes:
Locations:
city: Itagüí
country: Colombia
facility: Angiosur - Unidad Vascular Integral
state: Antioquia
Study officials:
affiliation: Angiosur
name: Boris Pabon, MD
role: PRINCIPAL_INVESTIGATOR
References: