DAISe 1 Feasibility Study to Evaluate the DAISe Thrombectomy System for Acute Ischemic Stroke

NCT05139147 | Terminated

• 1 other identifier: 101995
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 6

Brief Summary

The study is a prospective, multi-center, single arm, feasibility study that will enroll a maximum of 36 subjects. The maximum enrollment is 10 subjects per site. A maximum of 6 investigational centers in Europe will participate. Enrollment is expected to take about 9 months, subject participation will last about 3 months.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• Rate of first pass revascularization success

  First pass successful revascularization defined as mTICI (modified Treatment in Cerebral Ischemia) 2b-3 flow in the target vessel post-treatment with the DAISe Thrombectomy System used with aspiration.

  procedure

• Rate of symptomatic intracranial hemorrhage

  Symptomatic intracranial haemorrhage at 24 (+/-12) hours post-procedure as detected by CT/MRI with clinical deterioration of an NIHSS change of greater than or equal to 4

  12-36 hours

Secondary Outcomes (12)

• Rate of successful revascularization with the DAISe Device

  Procedure

• Rate of procedural final successful revascularization

  Procedure

• Rate of successful revascularization at procedure end

  Procedure

• Rate of successful device use

  Procedure

• Procedure time

  Procedure

Study Arms (1)

DAISe Thrombectomy System

EXPERIMENTAL

Mechanical thrombectomy utilizing the DAISe Thrombectomy System, consisting of the DAISe Thrombectomy Device and DAISe Delivery Catheter, used with aspiration.

Device: DAISe Thrombectomy System

Interventions

DAISe Thrombectomy System DEVICE

DAISe Thrombectomy System for mechanical thrombectomy

DAISe Thrombectomy System

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older.
• Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Rankin Score 0-1. Patient must be living in their own home, apartment or seniors lodge where no nursing care is required.
• Diagnosis of acute ischemic stroke and referred to interventional neuroradiology center for mechanical thrombectomy with study enrollment time planned within 8 hours from onset of symptoms.
• Disabling stroke defined as a baseline NIHSS \> 6.
• Thrombolytic therapy (IV tPA) received within 4.5 hours of onset/ last known well according to prescribed dosing OR documented ineligibility for thrombolytic therapy.
• Confirmed symptomatic, large vessel occlusion of the intracranial internal carotid artery, middle cerebral artery, M1, or M2 with mTICI 0-1.
• The following baseline imaging criteria should be met: MRI criterion- volume of diffusion restriction visually assessed ≤50 mL OR ASPECTs score 5-10 or T criterion- ASPECTS 6-10 on imaging NE-CT, CTA and/or CTP available
• Patient is affiliated in the social security system.

You may not qualify if:

• Computed tomography (CT) or Magnetic Resonance Imaging (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; if a woman is of child-bearing potential and urine or serum beta HCG test is positive.
• Severe contrast allergy or absolute contraindication to iodinated contrast.
• Renal failure (serum creatinine level ≥ 3 mg/dL or on dialysis).
• Severe, sustained hypertension resistant to treatment (SBP \>185 mmHg or DBP \>110 mmHg).
• Use of warfarin anticoagulation (or other applicable anti-vitamin k anticoagulants) with International Normalized Ratio (INR) \> 3.0 at the time of the procedure or any known hemorrhagic or coagulation deficiency.
• Use of a direct thrombin inhibitor within the last 48 hours; partial thromboplastin time (PTT) \> 2.0 times the normal prior to procedure.
• Cerebral vasculitis or evidence of active systemic infection.
• 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.
• Difficult endovascular access, difficult aortic arch or severe neurovascular tortuosity that will result in an inability to deliver endovascular therapy.
• Evidence of dissection in the carotid or target artery for treatment.

Sponsors & Collaborators

• MIVI Neuroscience, Inc.: lead

Study Sites (6)

CHU Pellegrin

Bordeaux, 33000, France

Location

CHU Montpellier

Montpellier, France

Location

CHU Urbains

Nancy, 54035, France

Location

CHU Bicetre Paris

Paris, 94270, France

Location

Groupe Hospitalier Pitie-Salpetriere

Paris, France

Location

Hôpital Purpan

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Christophe Cognard, MD, PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 1, 2021
• Study Start: January 12, 2022
• Primary Completion: July 20, 2023
• Study Completion: August 4, 2023
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)