COlombia DAISe FEasibility Exercise

NCT05631483 | Terminated

• 1 other identifier: 101929
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Rate of Successful Revascularization

  mTICI (Modified TICI) 2b-3 of the target vessel post-treatment with the DAISe Thrombectomy Device

  Procedure

• Rate of Symptomatic Intracranial Hemorrhage

  24 hours post-procedure

Secondary Outcomes (8)

• Rate of Procedure related Complications

  Through 90 day post-procedure

• Occurrence of all intracranial hemorrhage

  24 hours post-procedure

• All-cause mortality

  Through Acute Hospital Discharge

• Embolization to a New Vascular Territory

  Procedure

• Successful Revascularization after first attempt with DAISe

  Procedure

Study Arms (1)

DAISe

EXPERIMENTAL

DAISe Thrombectomy Device

Device: DAISe

Interventions

DAISe DEVICE

Use of the DAISe Thrombectomy Device

DAISe

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 0-2.
• 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.

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.
• 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).

Sponsors & Collaborators

• MIVI Neuroscience, Inc.: lead

Study Sites (1)

Angiosur - Unidad Vascular Integral

Itagüí, Antioquia, Colombia

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

• Boris Pabon, MD

  Angiosur

  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: October 19, 2022
• First Posted: November 30, 2022
• Study Start: June 14, 2022
• Primary Completion: April 26, 2023
• Study Completion: August 2, 2023
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

CO (1)