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出境医 / 临床实验 / A Study to Evaluate the DAISe System During Neurointervention for Acute Ischemic Stroke

A Study to Evaluate the DAISe System During Neurointervention for Acute Ischemic Stroke

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment Phase
Stroke, Acute Device: DAISe System Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, multi-center, prospective study where all eligible subjects are treated with the study device after enrollment.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center, Single Arm Study to Evaluate the DAISe System During Neurointervention for Acute Ischemic Stroke
Actual Study Start Date : August 15, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: DAISe System
The DAISe System consists of the DAISe thrombectomy device used in with the Q Aspiration Catheter.
 Device: DAISe System
The DAISe System is indicated for revascularization of patients with acute ischemic stroke for the removal of fresh thrombi from vessels in the neurovasculature.
Outcome Measures
Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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 ]
  2. Number of participants with successful revascularization of mTICI 3 as a result of the first attempt with the DAISe System [ Time Frame: intra-procedural ]
  3. Number of participants with successful revascularization of final mTICI 2b-3 at the end of the procedure [ Time Frame: intra-procedural ]
  4. Time from groin puncture to successful revascularization defined as final mTICI 2b-3 flow [ Time Frame: intra-procedural ]
  5. Rate of procedure-related complications [ Time Frame: post procedure through discharge ]
  6. Rate of embolization to a new vascular territory (ENT) [ Time Frame: intra-procedural ]
  7. Good functional outcome for participants measured by Modified Rankin Scale score of 0-2. [ Time Frame: 30 days and 3 months post procedure ]
    The Modified Rankin Scale (mRS) measures neurological disability or dependence for stroke patients on a scale of 0 (no symptoms) to 6 (deceased).

  8. Quality of life for participants: PROMIS Scale [ Time Frame: 3 months post procedure ]
    PROMIS Scale

  9. Rate of all cause mortality [ Time Frame: 30 days and 3 months post procedure ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
Contacts and Locations

Locations
Layout table for location information
Belgium
Erasme Hospital
Brussels, Belgium, 1070
Hospital Civil Marie Curie
Charleroi, Belgium, 140
Sponsors and Collaborators
MIVI Neuroscience, Inc.
Tracking Information
First Submitted Date  ICMJE May 17, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date June 17, 2020
Actual Study Start Date  ICMJE August 15, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Successful revascularization [ Time Frame: intra-procedural ]
    Defined as TICI 2b-3 flow in the target vessel post-treatment of up to three passes with the DAISe System.
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • 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 ]
    The Modified Rankin Scale (mRS) measures neurological disability or dependence for stroke patients on a scale of 0 (no symptoms) to 6 (deceased).
  • Quality of life for participants: PROMIS Scale [ Time Frame: 3 months post procedure ]
    PROMIS Scale
  • Rate of all cause mortality [ Time Frame: 30 days and 3 months post procedure ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Successful revascularization of mTICI 2b-3 as a result of the first attempt with the DAISe System [ Time Frame: intra-procedural ]
  • Successful revascularization of mTICI 3 as a result of the first attempt with the DAISe System [ Time Frame: intra-procedural ]
  • 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 ]
  • Embolization to a new vascular territory (ENT) [ Time Frame: intra-procedural ]
  • Good functional outcome measured by Modified Rankin Score of 0-2 [ Time Frame: 30 days and 3 months post procedure ]
  • Quality of life: PROMIS Scale [ Time Frame: 3 months post procedure ]
    PROMIS Scale
  • All cause mortality [ Time Frame: 30 days and 3 months post procedure ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the DAISe System During Neurointervention for Acute Ischemic Stroke
Official Title  ICMJE A Prospective, Multi-Center, Single Arm Study to Evaluate the DAISe System During Neurointervention for Acute Ischemic Stroke
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single arm, multi-center, prospective study where all eligible subjects are treated with the study device after enrollment.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stroke, Acute
Intervention  ICMJE Device: DAISe System
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 Arms  ICMJE Experimental: DAISe System
The DAISe System consists of the DAISe thrombectomy device used in with the Q Aspiration Catheter.
Intervention: Device: DAISe System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019) 		120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03957278
Other Study ID Numbers  ICMJE 101361
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party MIVI Neuroscience, Inc.
Study Sponsor  ICMJE MIVI Neuroscience, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account MIVI Neuroscience, Inc.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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