Clinical trial NCT04991038: Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients
Official title: Prospective, Multi-center, Randomized Study to Compare the Safety and Efficacy of the DAISe Thrombectomy System and Stent Retrievers for Neurointervention in Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Stroke, Ischemic
Stroke, Acute
Cerebrovascular Disorders
Cerebrovascular Accident
Keywords: DAISE
thrombectomy
Lead sponsor: MIVI Neuroscience, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare the safety and efficacy of the DAISE to stent retrievers in the treatment of acute ischemic stroke


Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* Pre-stroke independent functional status in activities of daily living with modified Rankin Score 0-1
* Patient presenting with a disabling stroke device as NIHSS ≥6
* Thrombolytic therapy (IV tPA), if indicated/administered, was initiated within 3 hours of onset/ last known well according to prescribed dosing.Endovascular treatment intended to be initiated (groin puncture) \<24 hours from onset of symptoms or last known well time.
* Confirmed symptomatic large vessel occlusion of the intracranial internal carotid artery, M1 or proximal M2 segment of the middle cerebral artery.
* The following image criteria should also be met:

For Subjects 0-6hrs onset:

* MRI Criterion: volume of diffusion restriction as assessed by automated core volume software ≤50mL OR
* CT Criterion: ASPECTS 6-10 on baseline CT or CTA-source images or, CPT as assessed by automated core volume software ≤50mL

For subjects 6-24hrs onset:

* ≤20mL Ischemic core volume if age \>80
* ≤30mL Ischemic core volume if age \<80 and NIHSS 10-20
* ≤50mL Ischemic core volume if age \<80 and NIHSS \>20
* Signed informed consent from patient or legal authorized representative.

Exclusion Criteria:

* CT or MRI evidence of intracranial hemorrhage on presentation.
* CT or MRI showing mass effect or intracranial tumor (meningioma \>2cm in diameter)
* CT or MRI evidence of carotid dissection or complete cervical carotid occlusion requiring a stent.
* Previous stroke within the past 3 months.
* Known arterial condition (proximal vessel stenosis or pre-existing stent) that would prevent the study devices from reaching the target vessel and/or preclude safe recovery of the study devices.
* Pregnancy.
* Severe contrast allergy or absolute contraindication to iodinated contrast.
* Rapidly improving neurological status as determined by Investigator/Neurologist.
* Renal failure/insufficiency with \>3.0 mg/dL creatinine prior to procedure.
* Severe, sustained hypertension resistant to treatment (SBP\>185mmHg or DBP \>110mmHg)
* Use of warfarin anticoagulation with International Normalized Ratio (INR) \>3.0 at the time of the procedure or any known hemorrhagic or coagulation deficiency.
* For patients who have received a direct thrombin inhibitor within the last 48hrs; partial thromboplastin time (PTT) \> 2.0 times the normal prior to procedure.
* Platelet count \< 50,000
* Cerebral vasculitis or evidence of active systemic infection (including COVID-19)
* Suspicion of aortic dissection, septic embolus, or 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.
* Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic.
* Active participation in another study involving an investigational drug or device.
* A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
* Unwillingness to complete follow up visits.

Primary outcomes:
measure: Primary Effectiveness Outcome: Good Functional Outcome of Modified Rankin Score 0-2
timeFrame: 90 days
measure: Primary Safety Outcome: Symptomatic intracranial hemorrhage
timeFrame: 24hrs post procedure
Secondary outcomes:
measure: mTICI 2b-3 after randomized modality
timeFrame: procedure after use of randomized device
measure: mTICI 2b-3 after first attempt with randomized modality
timeFrame: procedure after first attempt with randomized device
measure: mTICI 2c-3 after randomized modality
timeFrame: procedure after use of randomized device
measure: mTICI 2c-3 after the first attempt with randomized modality
timeFrame: procedure after first attempt with randomized device
measure: mTICI 2b-3 at end of the procedure
timeFrame: procedure after all interventions
measure: mTICI 2c-3 at end of the procedure
timeFrame: procedure after all interventions
measure: Procedure Time
timeFrame: procedure
measure: Rates of procedure and/or device related serious adverse events
timeFrame: 90 days
measure: Rate of all intracranial hemorrhage at 24hrs
timeFrame: 24hrs
measure: Rate of embolization to a new vascular territory (ENT) during procedure
timeFrame: procedure
measure: All-cause mortality at 90 days
timeFrame: 90 days
measure: Neurologic/Stroke related mortality at 90 days
timeFrame: 90 days
measure: Patient reported outcome assessment by PROMIS Global-10 at 90 days
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: UB/Kaleida Health
name: Adnan Siddiqui, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: U Penn Medical Center
name: Brian Jankowitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tennessee Health Sciences Center
name: Luvas Elijovich, MD
role: PRINCIPAL_INVESTIGATOR
References: