Stroke, Acute IschemicCOFEENCT05631483
COlombia DAISe FEasibility Exercise
A study testing DAISe in people with Stroke, Acute Ischemic, run by MIVI Neuroscience, Inc. at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute Ischemic
- What is being tested?
- DAISe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteColombia
- Study dates
- 14 Jun 2022to 2 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study for the DAISe Thrombectomy Device in Colombia
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
- Being tested
- DAISe
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAISeDevice
Use of the DAISe Thrombectomy Device
| Study group | Role | What they receive |
|---|---|---|
| DAISe | Experimental | DAISe Thrombectomy Device Receives: Device: DAISe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Successful Revascularization
mTICI (Modified TICI) 2b-3 of the target vessel post-treatment with the DAISe Thrombectomy Device
Measured: Procedure
Rate of Symptomatic Intracranial Hemorrhage
Measured: 24 hours post-procedure
Secondary outcomes (8)
Rate of Procedure related Complications
Measured: Through 90 day post-procedure
Occurrence of all intracranial hemorrhage
Measured: 24 hours post-procedure
All-cause mortality
Measured: Through Acute Hospital Discharge
Embolization to a New Vascular Territory
Measured: Procedure
Successful Revascularization after first attempt with DAISe
mTICI (modified TICI) 2b-3 after first pass with device
Measured: Procedure
Successful Revascularization after first attempt with DAISe
mTICI (modified TICI) 2c-3 after first pass with device
Measured: Procedure
Successful Revascularization at end of procedure
mTICI (modified TICI) 2b-3 at the end of procedure
Measured: Procedure
Successful Revascularization at end of procedure
mTICI (modified TICI) 2c-3 at the end of procedure
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start14 Jun 2022
- Primary completion26 Apr 2023
- Study completion2 Aug 2023
Why it stopped: Enrollment/Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, Acute IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- MIVI Neuroscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boris Pabon, MD, Principal investigator, Angiosur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631483
- Sponsor's protocol ID
- 101929
- Acronym
- COFEE
- Status last verified
- Aug 2024
- First submitted
- 19 Oct 2022
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study for the DAISe Thrombectomy Device in Colombia
- ClinicalTrials.gov ID
- NCT05631483
- Acronym / sponsor ID
- COFEE / 101929
- Conditions
- Stroke, Acute Ischemic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment/Recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- MIVI Neuroscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to assess initial safety and performance data of the DAISe Thrombectomy Device for removal of thrombus during an acute ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DAISe | Experimental | Device: DAISeDAISe Thrombectomy Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAISeUse of the DAISe Thrombectomy Device | Device | DAISe |
Primary outcome
Rate of Successful Revascularization
Time frame: Procedure
mTICI (Modified TICI) 2b-3 of the target vessel post-treatment with the DAISe Thrombectomy Device
Rate of Symptomatic Intracranial Hemorrhage
Time frame: 24 hours post-procedure
8 secondary outcomes
Rate of Procedure related Complications
Time frame: Through 90 day post-procedure
Occurrence of all intracranial hemorrhage
Time frame: 24 hours post-procedure
All-cause mortality
Time frame: Through Acute Hospital Discharge
Embolization to a New Vascular Territory
Time frame: Procedure
Successful Revascularization after first attempt with DAISe
Time frame: Procedure
Successful Revascularization after first attempt with DAISe
Time frame: Procedure
Successful Revascularization at end of procedure
Time frame: Procedure
Successful Revascularization at end of procedure
Time frame: Procedure
Results and safety
The study was stopped early (reason given: Enrollment/Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris Pabon, MD principal investigator
Angiosur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DAISe in people with Stroke, Acute Ischemic, run by MIVI Neuroscience, Inc. at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Enrollment/Recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Successful Revascularization (time frame: Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.