COlombia DAISe FEasibility Exercise

NCT ID: NCT05631483

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-14
• Study Completion Date: 2023-08-02

Brief Summary

This study is to assess initial safety and performance data of the DAISe Thrombectomy Device for removal of thrombus during an acute ischemic stroke.

Conditions

Stroke, Acute Ischemic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DAISe

DAISe Thrombectomy Device

Group Type: EXPERIMENTAL

DAISe

Intervention Type: DEVICE

Use of the DAISe Thrombectomy Device

Interventions

DAISe

Use of the DAISe Thrombectomy Device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 0-2.
• Diagnosis of acute ischemic stroke with study enrollment time < 8 hours from onset of symptoms.
• Disabling stroke defined as a baseline NIHSS > 6.
• Confirmed symptomatic, large vessel occlusion of the intracranial internal carotid artery, middle cerebral artery, M1.
• Signed informed consent from patient or legal representative.

Exclusion Criteria

• 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.
• 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.
• Presence of a carotid artery stenosis or occlusion requiring balloon angioplasty or stenting at time of the procedure.
• 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 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).
• A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MIVI Neuroscience, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boris Pabon, MD

Role: PRINCIPAL_INVESTIGATOR

Angiosur

Locations

Angiosur - Unidad Vascular Integral

Itagüí, Antioquia, Colombia

Countries

Colombia

Other Identifiers

101929

Identifier Type: -

Identifier Source: org_study_id