Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients (DAISE)
Primary Purpose
Stroke, Stroke, Ischemic, Stroke, Acute
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DAISe Device
Trevo or Solitaire
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring DAISE, thrombectomy
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DAISe Thrombectomy Device
Stent Retriever
Arm Description
Mechanical Thrombectomy with DAISe
Mechanical Thrombectomy with TREVO or Solitaire Device
Outcomes
Primary Outcome Measures
Primary Effectiveness Outcome: Good Functional Outcome of Modified Rankin Score 0-2
Primary Safety Outcome: Symptomatic intracranial hemorrhage
Secondary Outcome Measures
mTICI 2b-3 after randomized modality
mTICI 2b-3 after first attempt with randomized modality
mTICI 2c-3 after randomized modality
mTICI 2c-3 after the first attempt with randomized modality
mTICI 2b-3 at end of the procedure
mTICI 2c-3 at end of the procedure
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)
Rates of procedure and/or device related serious adverse events
Rate of all intracranial hemorrhage at 24hrs
Rate of embolization to a new vascular territory (ENT) during procedure
All-cause mortality at 90 days
Neurologic/Stroke related mortality at 90 days
Patient reported outcome assessment by PROMIS Global-10 at 90 days
Full Information
NCT ID
NCT04991038
First Posted
July 27, 2021
Last Updated
October 19, 2022
Sponsor
MIVI Neuroscience, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04991038
Brief Title
Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn, considering alternative trial design
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MIVI Neuroscience, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Compare the safety and efficacy of the DAISE to stent retrievers in the treatment of acute ischemic stroke
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke, Ischemic, Stroke, Acute, Cerebrovascular Disorders, Cerebrovascular Accident
Keywords
DAISE, thrombectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DAISe Thrombectomy Device
Arm Type
Experimental
Arm Description
Mechanical Thrombectomy with DAISe
Arm Title
Stent Retriever
Arm Type
Active Comparator
Arm Description
Mechanical Thrombectomy with TREVO or Solitaire Device
Intervention Type
Device
Intervention Name(s)
DAISe Device
Intervention Description
Thrombectomy using the DAISE device
Intervention Type
Device
Intervention Name(s)
Trevo or Solitaire
Intervention Description
Thrombectomy using TREVO or Solitaire device
Primary Outcome Measure Information:
Title
Primary Effectiveness Outcome: Good Functional Outcome of Modified Rankin Score 0-2
Time Frame
90 days
Title
Primary Safety Outcome: Symptomatic intracranial hemorrhage
Time Frame
24hrs post procedure
Secondary Outcome Measure Information:
Title
mTICI 2b-3 after randomized modality
Time Frame
procedure after use of randomized device
Title
mTICI 2b-3 after first attempt with randomized modality
Time Frame
procedure after first attempt with randomized device
Title
mTICI 2c-3 after randomized modality
Time Frame
procedure after use of randomized device
Title
mTICI 2c-3 after the first attempt with randomized modality
Time Frame
procedure after first attempt with randomized device
Title
mTICI 2b-3 at end of the procedure
Time Frame
procedure after all interventions
Title
mTICI 2c-3 at end of the procedure
Time Frame
procedure after all interventions
Title
Procedure Time
Description
Time from groin puncture to first successful revascularization devices as mTICI 2b-3 flow (as long as final mTICI 2b-3 is achieved)
Time Frame
procedure
Title
Rates of procedure and/or device related serious adverse events
Time Frame
90 days
Title
Rate of all intracranial hemorrhage at 24hrs
Time Frame
24hrs
Title
Rate of embolization to a new vascular territory (ENT) during procedure
Time Frame
procedure
Title
All-cause mortality at 90 days
Time Frame
90 days
Title
Neurologic/Stroke related mortality at 90 days
Time Frame
90 days
Title
Patient reported outcome assessment by PROMIS Global-10 at 90 days
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adnan Siddiqui, MD, PhD
Organizational Affiliation
UB/Kaleida Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brian Jankowitz, MD
Organizational Affiliation
U Penn Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luvas Elijovich, MD
Organizational Affiliation
University of Tennessee Health Sciences Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients
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