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

NCT03957278 | Terminated DMC

• 1 other identifier: 101361
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke, Acute

Keywords

Mechanical thrombectomy; Acute ischemic stroke; neurovascular intervention

Outcome Measures

Primary Outcomes (2)

• 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.

  intra-procedural

• Rate of symptomatic intracranial haemorrhage

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

  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

  intra-procedural

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

  intra-procedural

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

  intra-procedural

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

  intra-procedural

• Rate of procedure-related complications

  post procedure through discharge

Study Arms (1)

DAISe System

EXPERIMENTAL

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

Device: DAISe System

Interventions

DAISe System DEVICE

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

DAISe System

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MIVI Neuroscience, Inc.: lead

Study Sites (2)

Erasme Hospital

Brussels, 1070, Belgium

Location

Hospital Civil Marie Curie

Charleroi, 140, Belgium

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: August 15, 2019
• Primary Completion: May 1, 2020
• Study Completion: November 9, 2021
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)