Ischemic StrokeNCT04466033
Evaluation of the Safety and Performance of Magneto Microcatheter
A study testing Magneto Microcatheter in people with Ischemic Stroke, run by Magneto Thrombectomy Solutions at 3 sites in 2 countries.
Trial summary
A prospective, open label single arm feasibility study to evaluate the safety and performance of the Magneto Microcatheter 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 Microcatheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Nov 2020to 1 Jul 2024
- 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
- Clinical signs consistent with acute ischemic stroke
- Patient with Acute Ischemic Stroke within 24 hours from symptoms o
- Age 18-85 years old
- Consent process is completed per international and local regulations
Who cannot join
- Known use of cocaine or other vasoactive substance
- Known bleeding diathesis
- Any known hemorrhagic or coagulation deficiency.
- Current use of oral anticoagulants with International Normalized Ratio (INR) > 3;
- PTT (Partial Thromboplastin Time)>2 at screening
- Uncontrolled hypertension (Systolic blood pressure>185 or Diastolic blood pressure>110) refractory to pharmacological management
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- Pregnant or lactating female
- CT scan or MRI with evidence of acute intracranial hemorrhage, ASPECT score<6, mass effect and/or intracranial tumor
- Angiographic evidence of either carotid dissection or vasculitis at the target site or any condition that may limit device access to the target site (i.e high grade stenosis) per the treating physician's discretion.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Hungary1 site
National Institute of Mental Health, Neurology and Neurosurgery)
Budapest
About this study
Official title: Evaluation of the Safety and Performance of Magneto Microcatheter for Endovascular Thrombectomy in Patients With Acute Ischemic Stroke
A prospective, open label single arm feasibility study to evaluate the safety and performance of the Magneto Microcatheter in patients diagnosed with acute ischemic stroke and planned for thrombectomy procedure.
- Conditions
- Ischemic Stroke
- Being tested
- Magneto Microcatheter
- 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 MicrocatheterDevice
All patients will be treated with Magneto Microcatheter
| Study group | Role | What they receive |
|---|---|---|
| Magneto Microcatheter | Experimental | Not described Receives: Device: Magneto Microcatheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the safety of Magneto Microcatheter in the acute post procedure duration by assessing the incidence of device related Serious Adverse Events within 24 hours post procedure
Occurrence of device related Serious Adverse Events
Measured: 24 hours
Secondary outcomes (2)
Evaluation of the safety of Magneto Microcatheter by assessing the incidence of device related Serious Adverse Events within 90 days post procedure
Occurrence of device related Serious Adverse Events
Measured: 90 days
Evaluation of the performance of Magneto Microcatheter by assessing its ability to remove the clot and evaluating its ease of use
Assessment of device performance in clot removal (TICI scale to evaluate revascularization) and ease of use (questionnaire that will be completed by the treating physician post procedure)
Measured: During Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start1 Nov 2020
- Primary completion1 Apr 2024
- Study completion1 Jul 2024
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
- Dr. Marzelik, Principal investigator, Sheba Medical CenterDr.Amsalem, Principal investigator, Shaare Zedek, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466033
- Sponsor's protocol ID
- C14-CLN002
- Status last verified
- May 2025
- First submitted
- 5 Jul 2020
- Last updated
- 7 May 2025
- 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 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Performance of Magneto Microcatheter for Endovascular Thrombectomy in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04466033
- Acronym / sponsor ID
- C14-CLN002
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Magneto Thrombectomy SolutionsIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 10 Jul 2020 (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 Microcatheter 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 Microcatheter | Experimental | Device: Magneto Microcatheter |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical signs consistent with acute ischemic stroke
- Patient with Acute Ischemic Stroke within 24 hours from symptoms o
- Age 18-85 years old
- Consent process is completed per international and local regulations
Key exclusion criteria (9 listed)
- Known use of cocaine or other vasoactive substance
- Known bleeding diathesis
- Any known hemorrhagic or coagulation deficiency.
- Current use of oral anticoagulants with International Normalized Ratio (INR) > 3;
- PTT (Partial Thromboplastin Time)>2 at screening
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 MicrocatheterAll patients will be treated with Magneto Microcatheter | Device | Magneto Microcatheter |
Primary outcome
Evaluation of the safety of Magneto Microcatheter in the acute post procedure duration by assessing the incidence of device related Serious Adverse Events within 24 hours post procedure
Time frame: 24 hours
Occurrence of device related Serious Adverse Events
2 secondary outcomes
Evaluation of the safety of Magneto Microcatheter by assessing the incidence of device related Serious Adverse Events within 90 days post procedure
Time frame: 90 days
Evaluation of the performance of Magneto Microcatheter by assessing its ability to remove the clot and evaluating its ease of use
Time frame: During Procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- 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.
Dr. Marzelik principal investigator
Sheba Medical Center
Dr.Amsalem principal investigator
Shaare Zedek, Israel
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magneto Microcatheter in people with Ischemic Stroke, run by Magneto Thrombectomy Solutions at 3 sites in 2 countries.
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 9 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: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel, Hungary. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of the safety of Magneto Microcatheter in the acute post procedure duration by assessing the incidence of device related Serious Adverse Events within 24 hours post procedure (time frame: 24 hours). 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 May 2025.