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

Primary Purpose

Stroke, Acute

Status

Terminated

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

DAISe System

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring Mechanical thrombectomy, Acute ischemic stroke, neurovascular intervention

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Erasme Hospital
Hospital Civil Marie Curie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DAISe System

Arm Description

The DAISe System consists of the DAISe thrombectomy device used in with the Q Aspiration Catheter.

Outcomes

Primary Outcome Measures

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.

Rate of symptomatic intracranial haemorrhage

24 hours post-procedure as detected by CT/MRI with an NIHSS change of >4

Secondary Outcome Measures

Number of participants with successful revascularization of mTICI 2b-3 as a result of the first attempt with the DAISe System

Number of participants with successful revascularization of mTICI 3 as a result of the first attempt with the DAISe System

Number of participants with successful revascularization of final mTICI 2b-3 at the end of the procedure

Time from groin puncture to successful revascularization defined as final mTICI 2b-3 flow

Rate of procedure-related complications

Rate of embolization to a new vascular territory (ENT)

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).

Quality of life for participants: PROMIS Scale

PROMIS Scale

Rate of all cause mortality

Full Information

NCT ID

NCT03957278

First Posted

May 17, 2019

Last Updated

October 19, 2022

Sponsor

MIVI Neuroscience, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03957278

Brief Title

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

Official Title

A Prospective, Multi-Center, Single Arm Study to Evaluate the DAISe System During Neurointervention for Acute Ischemic Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Terminated

Why Stopped

Device modifications

Study Start Date

August 15, 2019 (Actual)

Primary Completion Date

May 1, 2020 (Actual)

Study Completion Date

November 9, 2021 (Actual)

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Acute

Keywords

Mechanical thrombectomy, Acute ischemic stroke, neurovascular intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single arm, multi-center, prospective study where all eligible subjects are treated with the study device after enrollment.

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DAISe System

Arm Type

Experimental

Arm Description

The DAISe System consists of the DAISe thrombectomy device used in with the Q Aspiration Catheter.

Intervention Type

Device

Intervention Name(s)

DAISe System

Intervention Description

The DAISe System is indicated for revascularization of patients with acute ischemic stroke for the removal of fresh thrombi from vessels in the neurovasculature.

Primary Outcome Measure Information:

Title

Number of participants with successful revascularization

Description

Defined as mTICI 2b-3 flow in the target vessel post-treatment of up to three passes with the DAISe System.

Time Frame

intra-procedural

Title

Rate of symptomatic intracranial haemorrhage

Description

24 hours post-procedure as detected by CT/MRI with an NIHSS change of >4

Time Frame

12-36 hours post procedure

Secondary Outcome Measure Information:

Title

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

Title

Number of participants with successful revascularization of mTICI 3 as a result of the first attempt with the DAISe System

Time Frame

intra-procedural

Title

Number of participants with successful revascularization of final mTICI 2b-3 at the end of the procedure

Time Frame

intra-procedural

Title

Time from groin puncture to successful revascularization defined as final mTICI 2b-3 flow

Time Frame

intra-procedural

Title

Rate of procedure-related complications

Time Frame

post procedure through discharge

Title

Rate of embolization to a new vascular territory (ENT)

Time Frame

intra-procedural

Title

Good functional outcome for participants measured by Modified Rankin Scale score of 0-2.

Description

The Modified Rankin Scale (mRS) measures neurological disability or dependence for stroke patients on a scale of 0 (no symptoms) to 6 (deceased).

Time Frame

30 days and 3 months post procedure

Title

Quality of life for participants: PROMIS Scale

Description

PROMIS Scale

Time Frame

3 months post procedure

Title

Rate of all cause mortality

Time Frame

30 days and 3 months post procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Erasme Hospital

City

Brussels

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Hospital Civil Marie Curie

City

Charleroi

ZIP/Postal Code

140

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

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

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