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COlombia DAISe FEasibility Exercise (COFEE)

Primary Purpose

Stroke, Acute Ischemic

Status
Recruiting
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
DAISe
Sponsored by
MIVI Neuroscience, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute Ischemic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Angiosur - Unidad Vascular IntegralRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DAISe

Arm Description

DAISe Thrombectomy Device

Outcomes

Primary Outcome Measures

Rate of Successful Revascularization
mTICI (Modified TICI) 2b-3 of the target vessel post-treatment with the DAISe Thrombectomy Device
Rate of Symptomatic Intracranial Hemorrhage

Secondary Outcome Measures

Rate of Procedure related Complications
Occurrence of all intracranial hemorrhage
All-cause mortality
Embolization to a New Vascular Territory
Successful Revascularization after first attempt with DAISe
mTICI (modified TICI) 2b-3 after first pass with device
Successful Revascularization after first attempt with DAISe
mTICI (modified TICI) 2c-3 after first pass with device
Successful Revascularization at end of procedure
mTICI (modified TICI) 2b-3 at the end of procedure
Successful Revascularization at end of procedure
mTICI (modified TICI) 2c-3 at the end of procedure

Full Information

First Posted
October 19, 2022
Last Updated
November 19, 2022
Sponsor
MIVI Neuroscience, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05631483
Brief Title
COlombia DAISe FEasibility Exercise
Acronym
COFEE
Official Title
A Feasibility Study for the DAISe Thrombectomy Device in Colombia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MIVI Neuroscience, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute Ischemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DAISe
Arm Type
Experimental
Arm Description
DAISe Thrombectomy Device
Intervention Type
Device
Intervention Name(s)
DAISe
Intervention Description
Use of the DAISe Thrombectomy Device
Primary Outcome Measure Information:
Title
Rate of Successful Revascularization
Description
mTICI (Modified TICI) 2b-3 of the target vessel post-treatment with the DAISe Thrombectomy Device
Time Frame
Procedure
Title
Rate of Symptomatic Intracranial Hemorrhage
Time Frame
24 hours post-procedure
Secondary Outcome Measure Information:
Title
Rate of Procedure related Complications
Time Frame
Through 90 day post-procedure
Title
Occurrence of all intracranial hemorrhage
Time Frame
24 hours post-procedure
Title
All-cause mortality
Time Frame
Through Acute Hospital Discharge
Title
Embolization to a New Vascular Territory
Time Frame
Procedure
Title
Successful Revascularization after first attempt with DAISe
Description
mTICI (modified TICI) 2b-3 after first pass with device
Time Frame
Procedure
Title
Successful Revascularization after first attempt with DAISe
Description
mTICI (modified TICI) 2c-3 after first pass with device
Time Frame
Procedure
Title
Successful Revascularization at end of procedure
Description
mTICI (modified TICI) 2b-3 at the end of procedure
Time Frame
Procedure
Title
Successful Revascularization at end of procedure
Description
mTICI (modified TICI) 2c-3 at the end of procedure
Time Frame
Procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chris Pierzchalski
Phone
2623910954
Email
cpierzchalski@mivineuro.com
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Valverde, MD
Phone
7863199950
Email
cvalverde@cosmosscientific.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris Pabon, MD
Organizational Affiliation
Angiosur
Official's Role
Principal Investigator
Facility Information:
Facility Name
Angiosur - Unidad Vascular Integral
City
Itagüí
State/Province
Antioquia
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Valverde, MD
Phone
+573008148383
Email
cvalverde@cosmosscientific.com
First Name & Middle Initial & Last Name & Degree
Boris Pabon, MD
First Name & Middle Initial & Last Name & Degree
Manuel Patino, MD

12. IPD Sharing Statement

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COlombia DAISe FEasibility Exercise

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