Ischemic StrokeNCT03890380
Safety and Performance Evaluation of the Magneto Wire
A study testing Magneto Wire in people with Ischemic Stroke, run by Magneto Thrombectomy Solutions at 1 site in Israel.
Trial summary
A prospective, open label single arm feasibility study to evaluate the safety and performance of the Magneto Wire in patients diagnosed with acute ischemic stroke and planned for thrombectomy procedure. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Magneto Wire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteIsrael
- Study dates
- 17 Dec 2018to 27 Oct 2019
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute ischemic stroke within defined timelines.
- Age 18-85 years old
- NIHSS ≥ 8
- No significant pre-stroke functional disability (mRS ≤ 1)
Who cannot join
- Life expectancy of less than 90 days
- Neurological signs that are rapidly improving prior to or at time of treatment
- NIHSS≥30 or state of coma
- Ongoing seizure
- Current use of cocaine or other vasoactive substance
- Known bleeding diathesis
Show all 20Show fewer
- Known hemorrhagic or coagulation deficiency
- Evidence of active systemic infection
- Current use of oral anticoagulants INR > 3
- Administration of heparin or Novel Oral Anticoagulants within 48 hours preceding the onset of stroke and have an abnormal aPTT at presentation
- Platelet count < 50,000/mm3
- Glucose <50 mg/dL (2.8 mmol, 2.6mM)
- Uncontrolled hypertension (SBP>185 or DBP>110) refractory to pharmacological management
- Known hypersensitivity or allergy to radiographic contrast agents
- Pregnancy or lactating female
- Subject already enrolled in a clinical study involving experimental medication or device
- CT scan or MRI with evidence of acute intracranial hemorrhage, ASPECT score<6, mass effect and/or intracranial tumor.
- Angiographic evidence of carotid dissection, or high grade stenosis that will prevent access to the clot, or cerebral vasculitis, or intracranial stenosis
- Blood vessel with extreme tortuosity or other conditions preventing the access of the device.
- Angiographic evidence of carotid dissection, complete cervical carotid occlusions or vasculitis.
Trial locations and contacts
1 site in 1 country.
About this study
A prospective, open label single arm feasibility study to evaluate the safety and performance of the Magneto Wire in patients diagnosed with acute ischemic stroke and planned for thrombectomy procedure.
- Conditions
- Ischemic Stroke
- Being tested
- Magneto Wire
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magneto WireDevice
Patients will be treated with Magneto Wire
| Study group | Role | What they receive |
|---|---|---|
| Magneto Wire | Experimental | Patients treated with Magneto Wire Receives: Device: Magneto Wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessment
Occurrence of Device-related Serious Adverse Events (SAEs)
Measured: 24 (±8) hours post procedure
Secondary outcomes (5)
Safety Assessment
Occurrence of Device-related Serious Adverse Events (SAEs)
Measured: 90 (±10) days
Revascularization
Revascularization in the immediate post procedure angiogram, using modified Thrombolysis in Cerebrovascular Infarction (mTIC≥2b)
Measured: immediate
Distal Embolism
Evidence of Infarction of a previously uninvolved vascular territory in the immediate post procedure angiogram
Measured: immediate
National Institutes of Health Stroke Scale (NIHSS)
NIHSS scale is used to evaluate the severity of a stroke by assessing the stroke-related neurologic deficit. Scores range from 0-42, a higher score indicates a higher severity.
Measured: 24 (±8) hours post procedure
Modified Rankin Scale
Modified Rankin scale is used to evaluate the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scores range from 0-6 (0-no symptoms, 6- death)
Measured: 90 (±10) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start17 Dec 2018
- Primary completion18 Jul 2019
- Study completion27 Oct 2019
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Magneto Thrombectomy Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shally Sharon, Study director, Magneto Thrombectomy Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890380
- Sponsor's protocol ID
- CLP-01
- Status last verified
- Jul 2020
- First submitted
- 25 Mar 2019
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Evaluation of the Magneto Wire
- ClinicalTrials.gov ID
- NCT03890380
- Acronym / sponsor ID
- CLP-01
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Magneto Thrombectomy SolutionsIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 18 Jul 2019 (actual)
- Study completion
- 27 Oct 2019 (actual)
- First posted
- 26 Mar 2019 (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.
A prospective, open label single arm feasibility study to evaluate the safety and performance of the Magneto Wire in patients diagnosed with acute ischemic stroke and planned for thrombectomy procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magneto Wire | Experimental | Device: Magneto WirePatients treated with Magneto Wire |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute ischemic stroke within defined timelines.
- Age 18-85 years old
- NIHSS ≥ 8
- No significant pre-stroke functional disability (mRS ≤ 1)
Key exclusion criteria (20 listed)
- Life expectancy of less than 90 days
- Neurological signs that are rapidly improving prior to or at time of treatment
- NIHSS≥30 or state of coma
- Ongoing seizure
- Current use of cocaine or other vasoactive substance
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 |
|---|---|---|
| Magneto WirePatients will be treated with Magneto Wire | Device | Magneto Wire |
Primary outcome
Safety Assessment
Time frame: 24 (±8) hours post procedure
Occurrence of Device-related Serious Adverse Events (SAEs)
5 secondary outcomes
Safety Assessment
Time frame: 90 (±10) days
Revascularization
Time frame: immediate
Distal Embolism
Time frame: immediate
National Institutes of Health Stroke Scale (NIHSS)
Time frame: 24 (±8) hours post procedure
Modified Rankin Scale
Time frame: 90 (±10) days
Results and safety
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Shally Sharon study director
Magneto Thrombectomy Solutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magneto Wire in people with Ischemic Stroke, run by Magneto Thrombectomy Solutions at 1 site in Israel.
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 4 inclusion and 20 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 7 Jul 2020. 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 Israel. 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: Sponsor's decision). 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?
Safety Assessment (time frame: 24 (±8) hours post procedure). 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 7 Jul 2020.