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

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.

Study Overview

• Status: Terminated
• Conditions: Stroke, Acute
• Intervention / Treatment: Device: DAISe System

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: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Erasme Hospital
  • Charleroi, Belgium, 140
    • Hospital Civil Marie Curie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Rate of embolization to a new vascular territory (ENT)		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).	30 days and 3 months post procedure
Quality of life for participants: PROMIS Scale	PROMIS Scale	3 months post procedure
Rate of all cause mortality		30 days and 3 months post procedure

Collaborators and Investigators

• Sponsor: MIVI Neuroscience, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): November 9, 2021

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Acute ischemic stroke; Mechanical thrombectomy; neurovascular intervention
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 101361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No