Stroke Clinical Trial
— DAISEOfficial 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
NCT number | NCT04991038 |
Other study ID # | 101903 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2022 |
Est. completion date | September 2024 |
Verified date | October 2022 |
Source | MIVI Neuroscience, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Compare the safety and efficacy of the DAISE to stent retrievers in the treatment of acute ischemic stroke
Status | Withdrawn |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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
MIVI Neuroscience, Inc. |
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 |
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