Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients

Stroke Clinical Trial

— DAISE  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04991038
• Other study ID #: 101903
• Status: Withdrawn
• Phase: N/A
• Start date: September 2022
• Est. completion date: September 2024

Study information

• Verified date: October 2022
• Source: MIVI Neuroscience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Cerebrovascular Disorders
• Ischemia
• Ischemic Stroke
• Stroke
• Stroke, Acute
• Stroke, Ischemic

Intervention

Device:
• DAISe Device
Thrombectomy using the DAISE device
• Trevo or Solitaire
Thrombectomy using TREVO or Solitaire device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MIVI Neuroscience, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Effectiveness Outcome: Good Functional Outcome of Modified Rankin Score 0-2		90 days
Primary	Primary Safety Outcome: Symptomatic intracranial hemorrhage		24hrs post procedure
Secondary	mTICI 2b-3 after randomized modality		procedure after use of randomized device
Secondary	mTICI 2b-3 after first attempt with randomized modality		procedure after first attempt with randomized device
Secondary	mTICI 2c-3 after randomized modality		procedure after use of randomized device
Secondary	mTICI 2c-3 after the first attempt with randomized modality		procedure after first attempt with randomized device
Secondary	mTICI 2b-3 at end of the procedure		procedure after all interventions
Secondary	mTICI 2c-3 at end of the procedure		procedure after all interventions
Secondary	Procedure Time	Time from groin puncture to first successful revascularization devices as mTICI 2b-3 flow (as long as final mTICI 2b-3 is achieved)	procedure
Secondary	Rates of procedure and/or device related serious adverse events		90 days
Secondary	Rate of all intracranial hemorrhage at 24hrs		24hrs
Secondary	Rate of embolization to a new vascular territory (ENT) during procedure		procedure
Secondary	All-cause mortality at 90 days		90 days
Secondary	Neurologic/Stroke related mortality at 90 days		90 days
Secondary	Patient reported outcome assessment by PROMIS Global-10 at 90 days		90 days