StrokeDAISENCT04991038
Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients
A study testing DAISe Device and Trevo or Solitaire in people with Stroke and Stroke, Ischemic, run by MIVI Neuroscience, Inc..
Trial summary
Compare the safety and efficacy of the DAISE to stent retrievers in the treatment of acute ischemic stroke Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke, Ischemic, Stroke, Acute
- What is being tested?
- DAISe Device and Trevo or Solitaire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
About this study
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
Compare the safety and efficacy of the DAISE to stent retrievers in the treatment of acute ischemic stroke
- Conditions
- Stroke, Stroke, Ischemic, Stroke, Acute, Cerebrovascular Disorders, Cerebrovascular Accident
- Being tested
- DAISe Device, Trevo or Solitaire
- Keywords
- DAISE, thrombectomy
- Medical subject headings
- Stroke, Ischemic Stroke, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAISe DeviceDevice
Thrombectomy using the DAISE device
Trevo or SolitaireDevice
Thrombectomy using TREVO or Solitaire device
| Study group | Role | What they receive |
|---|---|---|
| DAISe Thrombectomy Device | Experimental | Mechanical Thrombectomy with DAISe Receives: Device: DAISe Device |
| Stent Retriever | Active comparator | Mechanical Thrombectomy with TREVO or Solitaire Device Receives: Device: Trevo or Solitaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Outcome: Good Functional Outcome of Modified Rankin Score 0-2
Measured: 90 days
Primary Safety Outcome: Symptomatic intracranial hemorrhage
Measured: 24hrs post procedure
Secondary outcomes (13)
mTICI 2b-3 after randomized modality
Measured: procedure after use of randomized device
mTICI 2b-3 after first attempt with randomized modality
Measured: procedure after first attempt with randomized device
mTICI 2c-3 after randomized modality
Measured: procedure after use of randomized device
mTICI 2c-3 after the first attempt with randomized modality
Measured: procedure after first attempt with randomized device
mTICI 2b-3 at end of the procedure
Measured: procedure after all interventions
mTICI 2c-3 at end of the procedure
Measured: procedure after all interventions
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)
Measured: procedure
Rates of procedure and/or device related serious adverse events
Measured: 90 days
Rate of all intracranial hemorrhage at 24hrs
Measured: 24hrs
Rate of embolization to a new vascular territory (ENT) during procedure
Measured: procedure
All-cause mortality at 90 days
Measured: 90 days
Neurologic/Stroke related mortality at 90 days
Measured: 90 days
Patient reported outcome assessment by PROMIS Global-10 at 90 days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study startSep 2022 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Why it stopped: Withdrawn, considering alternative trial design
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MIVI Neuroscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adnan Siddiqui, MD, PhD, Principal investigator, UB/Kaleida HealthBrian Jankowitz, MD, Principal investigator, U Penn Medical CenterLuvas Elijovich, MD, Principal investigator, University of Tennessee Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991038
- Sponsor's protocol ID
- 101903
- Acronym
- DAISE
- Status last verified
- Oct 2022
- First submitted
- 27 Jul 2021
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04991038
- Acronym / sponsor ID
- DAISE / 101903
- Conditions
- Stroke, Stroke, Ischemic, Stroke, Acute, Cerebrovascular Disorders, Cerebrovascular Accident
- Keywords
- DAISE, thrombectomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn, considering alternative trial design
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MIVI Neuroscience, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare the safety and efficacy of the DAISE to stent retrievers in the treatment of acute ischemic stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAISe Thrombectomy Device | Experimental | Device: DAISe DeviceMechanical Thrombectomy with DAISe |
| Stent Retriever | Active comparator | Device: Trevo or SolitaireMechanical Thrombectomy with TREVO or Solitaire Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAISe DeviceThrombectomy using the DAISE device | Device | DAISe Thrombectomy Device |
| Trevo or SolitaireThrombectomy using TREVO or Solitaire device | Device | Stent Retriever |
Primary outcome
Primary Effectiveness Outcome: Good Functional Outcome of Modified Rankin Score 0-2
Time frame: 90 days
Primary Safety Outcome: Symptomatic intracranial hemorrhage
Time frame: 24hrs post procedure
13 secondary outcomes
mTICI 2b-3 after randomized modality
Time frame: procedure after use of randomized device
mTICI 2b-3 after first attempt with randomized modality
Time frame: procedure after first attempt with randomized device
mTICI 2c-3 after randomized modality
Time frame: procedure after use of randomized device
mTICI 2c-3 after the first attempt with randomized modality
Time frame: procedure after first attempt with randomized device
mTICI 2b-3 at end of the procedure
Time frame: procedure after all interventions
mTICI 2c-3 at end of the procedure
Time frame: procedure after all interventions
Procedure Time
Time frame: procedure
Rates of procedure and/or device related serious adverse events
Time frame: 90 days
Rate of all intracranial hemorrhage at 24hrs
Time frame: 24hrs
Rate of embolization to a new vascular territory (ENT) during procedure
Time frame: procedure
All-cause mortality at 90 days
Time frame: 90 days
Neurologic/Stroke related mortality at 90 days
Time frame: 90 days
Patient reported outcome assessment by PROMIS Global-10 at 90 days
Time frame: 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adnan Siddiqui, MD, PhD principal investigator
UB/Kaleida Health
Brian Jankowitz, MD principal investigator
U Penn Medical Center
Luvas Elijovich, MD principal investigator
University of Tennessee Health Sciences Center
Questions about this trial
What is this clinical trial studying?
A study testing DAISe Device and Trevo or Solitaire in people with Stroke and Stroke, Ischemic, run by MIVI Neuroscience, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Outcome: Good Functional Outcome of Modified Rankin Score 0-2 (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.