Stroke, AcuteNCT03957278
A Study to Evaluate the DAISe System During Neurointervention for Acute Ischemic Stroke
A study testing DAISe System in people with Stroke, Acute, run by MIVI Neuroscience, Inc. at 2 sites in Belgium.
Trial summary
This purpose study is to demonstrate the safety and performance of the DAISe System used to remove clot in the brain during a stroke. This study will assess how well the device removes clot from the brain and how well patients recover from their stroke. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- DAISe System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesBelgium
- Study dates
- 15 Aug 2019to 9 Nov 2021
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 85 years.
- Diagnosis of acute ischemic stroke with study enrollment time < 8 hours from onset of symptoms.
- Disabling stroke defined as a baseline NIHSS > 6.
- Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Rankin Score 0-1.
- If thrombolytic therapy (tPA) is administered, it must be administered per the prescribing information.
- Confirmed symptomatic intracranial occlusion, based on single phase, multiphase or dynamic CTA, at one or more of the following locations: Carotid T/L, M1 MCA, or M1-MCA equivalent (2 or more M2-MCAs), or M2-MCA.
- The following baseline imaging criteria should be met: MRI criterion: ASPECTS Score > 4 OR CT criterion: ASPECTS > 6
- Signed informed consent from patient or legally authorized representative.
Who cannot join
- CT or MRI evidence of recent/ fresh hemorrhage on presentation.
- Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic.
- Rapidly improving neurological deficits based on the investigator's clinical judgement.
- Pregnancy
- Severe contrast allergy or absolute contraindication to iodinated contrast.
- No femoral pulses or very difficult endovascular access that will result in an inability to deliver endovascular therapy.
Show all 17Show fewer
- Evidence of dissection in the carotid or middle cerebral arteries.
- Severe unilateral or bilateral carotid artery stenosis requiring treatment at the time of the procedure as determined during diagnostic angiography.
- Renal failure (serum creatinine level ≥ 4 mg/dL or on dialysis).
- Severe, sustained hypertension (SBP >185 mmHg or DBP >110 mmHg).
- Cerebral vasculitis.
- Suspicion of aortic dissection, presumed septic embolus or suspicion of 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.
- Platelet count < 50,000/mm3.
- A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
- Patient is unable or unwilling complete follow up visits.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Erasme Hospital
Brussels, 1070
Hospital Civil Marie Curie
Charleroi, 140
About this study
Official title: A Prospective, Multi-Center, Single Arm Study to Evaluate the DAISe System During Neurointervention for Acute Ischemic Stroke
This purpose study is to demonstrate the safety and performance of the DAISe System used to remove clot in the brain during a stroke. This study will assess how well the device removes clot from the brain and how well patients recover from their stroke. This study plans to enroll 100 study patients at up to 10 hospitals in Europe. Study patients are followed for 3 months after the procedure.
Read the detailed description
The study is a prospective, multi-center, single arm study that will enroll a maximum of 90 subjects, plus up to 50 roll-in subjects. A maximum of 10 sites in Europe will be involved in this study. The primary performance endpoint is successful revascularization defined as TICI 2b-3 flow in the target vessel post-treatment of up to three passes with the DAISe System. The primary safety endpoint is symptomatic intracranial haemorrhage at 24 hours post-procedure as detected by CT/MRI with an NIHSS change of >/=4. Subject will be followed through hospital discharge with a visit at Day 1 post procedure, Day 7 or prior to discharge/transfer, 30 days and 3 months.
- Conditions
- Stroke, Acute
- Being tested
- DAISe System
- Keywords
- Mechanical thrombectomy, Acute ischemic stroke, neurovascular intervention
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAISe SystemDevice
The DAISe System is indicated for revascularization of patients with acute ischemic stroke for the removal of fresh thrombi from vessels in the neurovasculature.
| Study group | Role | What they receive |
|---|---|---|
| DAISe System | Experimental | The DAISe System consists of the DAISe thrombectomy device used in with the Q Aspiration Catheter. Receives: Device: DAISe System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with successful revascularization
Defined as mTICI 2b-3 flow in the target vessel post-treatment of up to three passes with the DAISe System.
Measured: intra-procedural
Rate of symptomatic intracranial haemorrhage
24 hours post-procedure as detected by CT/MRI with an NIHSS change of >4
Measured: 12-36 hours post procedure
Secondary outcomes (9)
Number of participants with successful revascularization of mTICI 2b-3 as a result of the first attempt with the DAISe System
Measured: intra-procedural
Number of participants with successful revascularization of mTICI 3 as a result of the first attempt with the DAISe System
Measured: intra-procedural
Number of participants with successful revascularization of final mTICI 2b-3 at the end of the procedure
Measured: intra-procedural
Time from groin puncture to successful revascularization defined as final mTICI 2b-3 flow
Measured: intra-procedural
Rate of procedure-related complications
Measured: post procedure through discharge
Rate of embolization to a new vascular territory (ENT)
Measured: intra-procedural
Good functional outcome for participants measured by Modified Rankin Scale score of 0-2.
The Modified Rankin Scale (mRS) measures neurological disability or dependence for stroke patients on a scale of 0 (no symptoms) to 6 (deceased).
Measured: 30 days and 3 months post procedure
Quality of life for participants: PROMIS Scale
PROMIS Scale
Measured: 3 months post procedure
Rate of all cause mortality
Measured: 30 days and 3 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start15 Aug 2019
- Primary completion1 May 2020
- Study completion9 Nov 2021
Why it stopped: Device modifications
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, multi-center, prospective study where all eligible subjects are treated with the study device after enrollment.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- MIVI Neuroscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957278
- Sponsor's protocol ID
- 101361
- Status last verified
- Oct 2022
- First submitted
- 17 May 2019
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Single Arm Study to Evaluate the DAISe System During Neurointervention for Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03957278
- Acronym / sponsor ID
- 101361
- Conditions
- Stroke, Acute
- Keywords
- Mechanical thrombectomy, Acute ischemic stroke, neurovascular intervention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Device modifications
- Enrolment
- 4 participants (actual)
- Lead sponsor
- MIVI Neuroscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 21 May 2019 (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.
This purpose study is to demonstrate the safety and performance of the DAISe System used to remove clot in the brain during a stroke. This study will assess how well the device removes clot from the brain and how well patients recover from their stroke. This study plans to enroll 100 study patients at up to 10 hospitals in Europe. Study patients are followed for 3 months after the procedure.
Detailed description
The study is a prospective, multi-center, single arm study that will enroll a maximum of 90 subjects, plus up to 50 roll-in subjects. A maximum of 10 sites in Europe will be involved in this study. The primary performance endpoint is successful revascularization defined as TICI 2b-3 flow in the target vessel post-treatment of up to three passes with the DAISe System. The primary safety endpoint is symptomatic intracranial haemorrhage at 24 hours post-procedure as detected by CT/MRI with an NIHSS change of >/=4. Subject will be followed through hospital discharge with a visit at Day 1 post procedure, Day 7 or prior to discharge/transfer, 30 days and 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, multi-center, prospective study where all eligible subjects are treated with the study device after enrollment.
| Arm | Type | Receives |
|---|---|---|
| DAISe System | Experimental | Device: DAISe SystemThe DAISe System consists of the DAISe thrombectomy device used in with the Q Aspiration Catheter. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 to 85 years.
- Diagnosis of acute ischemic stroke with study enrollment time < 8 hours from onset of symptoms.
- Disabling stroke defined as a baseline NIHSS > 6.
- Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Rankin Score 0-1.
- If thrombolytic therapy (tPA) is administered, it must be administered per the prescribing information.
Key exclusion criteria (17 listed)
- CT or MRI evidence of recent/ fresh hemorrhage on presentation.
- Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic.
- Rapidly improving neurological deficits based on the investigator's clinical judgement.
- Pregnancy
- Severe contrast allergy or absolute contraindication to iodinated contrast.
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 SystemThe DAISe System is indicated for revascularization of patients with acute ischemic stroke for the removal of fresh thrombi from vessels in the neurovasculature. | Device | DAISe System |
Primary outcome
Number of participants with successful revascularization
Time frame: intra-procedural
Defined as mTICI 2b-3 flow in the target vessel post-treatment of up to three passes with the DAISe System.
Rate of symptomatic intracranial haemorrhage
Time frame: 12-36 hours post procedure
24 hours post-procedure as detected by CT/MRI with an NIHSS change of >4
9 secondary outcomes
Number of participants with successful revascularization of mTICI 2b-3 as a result of the first attempt with the DAISe System
Time frame: intra-procedural
Number of participants with successful revascularization of mTICI 3 as a result of the first attempt with the DAISe System
Time frame: intra-procedural
Number of participants with successful revascularization of final mTICI 2b-3 at the end of the procedure
Time frame: intra-procedural
Time from groin puncture to successful revascularization defined as final mTICI 2b-3 flow
Time frame: intra-procedural
Rate of procedure-related complications
Time frame: post procedure through discharge
Rate of embolization to a new vascular territory (ENT)
Time frame: intra-procedural
Good functional outcome for participants measured by Modified Rankin Scale score of 0-2.
Time frame: 30 days and 3 months post procedure
Quality of life for participants: PROMIS Scale
Time frame: 3 months post procedure
Rate of all cause mortality
Time frame: 30 days and 3 months post procedure
Results and safety
The study was stopped early (reason given: Device modifications). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Stroke, Acute
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
Not yet recruitingPhase 3
INTRA-ARTERIAL MeVO TREATMENT (IMP-ACT) Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632
Stroke, Acute Ischemic, Medium Vessel Occlusion
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DAISe System in people with Stroke, Acute, run by MIVI Neuroscience, Inc. at 2 sites in Belgium.
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 8 inclusion and 17 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: stopped early, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Device modifications). Results are not available in the source record.
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?
Number of participants with successful revascularization (time frame: intra-procedural). 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 20 Oct 2022.