Ischemic StrokeNCT02994563
Amnis Therapeutics Thrombectomy Device-First in Man (FIM) Safety and Performance Study
A study testing Thrombectomy Device in people with Ischemic Stroke, run by Amnis Therapeutics at 4 sites in 2 countries.
Trial summary
Prospective, single-arm, open label, Safety and Performance clinical investigation. 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?
- Thrombectomy Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 7 Oct 2019to 1 Mar 2021
- 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
- Aged18-85years.
- Subject who is contraindicated or failed (when the physician withdraws the tPA per physician discretion) intravenous tissue plasminogen activator (t-PA) therapy given at local institutions or within national practice. Failed means that the physician does not continue with IV tPA after thrombolysis; there is still an occlusion with TICI that is </= 1 as the relevant inclusion criteria.
- Subject is able to be treated within 8 hours of stroke symptoms onset with minimum of one deployment of the Amnis Thrombectomy Device.
- NIHSS score ≥8.
- Pre-stroke mRS (modified Rankin Scale) score of 0 to 1.
- Thrombolysis in cerebral infarction (TICI) ≤1 and causative occlusion of the M1 or M2 portion of the MCAs, anterior cerebral arteries, vertebral arteries, basilar artery ,or posterior cerebral arteries (P1 o rP2), confirmed by CT or MR angiography that is accessible to the Amnis thrombectomy device (i.e. according to IFU; 2-5.5 mm).
- ASPECTS of ≥6 based on CT or MRI that was performed within 60 min prior to the start of endovascular procedure.
- Subject or subject's legal guardian where regulations permit, signs the Patient Informed Consent and agrees that subject will attend follow-up visits.
Who cannot join
- Rapid neurological improvement prior to or at time of treatment suggesting resolution of signs/symptoms of stroke.
- Estimated time of symptom onset.
- Baseline NIHSS score <8.
- BaselineNIHSS score ≥30 or state of coma.
- Baseline pre-stroke mRS score >1.
- Baseline Thrombolysis in cerebral infarction (TICI) > 2a.
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- Known serious sensitivity to radiographic contrast agent.
- Arterial tortuosity, pre-existing stent and/o rother arterial disease that would prevent the device from reaching the target vessel.
- Evidence of a moderate/large core defined as extensive early ischemic changes of Alberta Stroke Program Early CT score (ASPECTS) <6.
- Co-morbid conditions:
- Elevated blood pressure(systolic>185 mm Hg or diastolic >110 mm Hg)
- Use of warfarin anticoagulation with INR >3.0.
- Platelet count <30,000/mm³.
- Blood glucose concentration <50 mg/dL (2.7 mmol/L).
- CT/MRI imaging demonstrate smultilobar infarction (hypodensity >1/3 cerebral hemisphere).
- CT or MRI evidence of mass effect, signs of hemorrhage, arteriovenous malformation or aneurysm or intra-cranial tumor (except small meningioma).
- Angiographic evidence of carotid dissection, complete cervical carotid occlusions or vasculitis.
- Clinical Symptoms or CT/MRI imaging suggest subarachnoid hemorrhage.
- Imaging evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention (e.g. inability to navigate to target lesion, moderate/large infarct with poor collateral circulation, etc.).
- General - related to the protocol or device:
- Known sensitivity to nickel, titanium metals or their alloys.
- Subject who requires hemodialysis or peritoneal dialysis, or who has a contraindication to an angiogram for whatever reason.
- Current participation in another investigational drug or device study.
- Female who is pregnant or lactating or has a positive pregnancy test at time of admission.
- Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day).
- Subject has a life expectancy of <90 days.
- Subject with a comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Spain3 sites
Hospital Vall d'Hebron; Unidad Ictus
Barcelona, 08035
Hospital Clinico of Barcelona; Section of Vascular Radiology & Neuroradiology
Barcelona, 08036
Hospital Clínico Universitario (Valladolid); Dept. Neurology
Valladolid, 47003
About this study
Prospective, single-arm, open label, Safety and Performance clinical investigation.
Read the detailed description
The Amnis Thrombectomy Device is intended to restore blood flow by removing thrombus from intracranial vessels in patients experiencing ischemic stroke. Pre-CE mark clinical investigation. Population will be subjects with documented untreated, acute ischemic stroke with large vessel occlusion.
- Conditions
- Ischemic Stroke
- Being tested
- Thrombectomy Device
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombectomy DeviceDevice
The Amnis Thrombectomy Device is intended to restore blood flow by removing thrombus from intracranial vessels in patients experiencing ischemic stroke
| Study group | Role | What they receive |
|---|---|---|
| Open arm | Experimental | Thrombectomy device to be used to retrieve clot and restore blood flow. Receives: Device: Thrombectomy Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
All serious adverse events (notably at 24 hours ± 3 hrs post procedure or until alternative stroke treatment is initiated, whichever comes first).
It will investigate whether the application of Amnis Thrombectomy device is a safe method, in acute stroke therapy, for obtaining recanalization of large vessels and with favorable patient outcome.
Measured: 24 hours ± 3 hrs post procedure or until alternative stroke treatment is initiated, whichever comes first.
All cause mortality (90 days).
Determine the number of participants with treatment-related adverse events.
Measured: 3 months post-procedure
Secondary outcomes (3)
Arterial recanalization of the occluded target vessel in the immediate post-procedure angiogram.
Arterial recanalization of the occluded target vessel as angiographically scored by a Thrombolysis in Cerebral Infarction (TICI) flow grade of 2b or greater in the immediate post-procedure angiogram.
Measured: Immediate post-procedure angiogram.
Proportion of patients with rapid neurological improvement as determined by a NIHSS ≤4.
Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS or NIHSS ≤4) during the first 24 hours after treatment.
Measured: First 24 hours after treatment
Good functional clinical outcome as determine by a modified Rankin Scale score of 0-2.
Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS or NIHSS ≤4) during the first 24 hours after treatment.
Measured: First 24 hours after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study start7 Oct 2019
- Primary completion25 Feb 2021
- Study completion1 Mar 2021
Why it stopped: Subject recruitment problem due to Covid pandemic
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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amnis Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tommy Andersson, M.D.; Ph.D., Principal investigator, Karolinska Institute, Neuroradiology Clinic, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994563
- Sponsor's protocol ID
- AmGR01
- Status last verified
- Jul 2022
- First submitted
- 5 Dec 2016
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amnis Therapeutics Thrombectomy Device-First in Man (FIM) Safety and Performance Study
- ClinicalTrials.gov ID
- NCT02994563
- Acronym / sponsor ID
- AmGR01
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Subject recruitment problem due to Covid pandemic
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Amnis TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 16 Dec 2016 (estimated)
- 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.
Prospective, single-arm, open label, Safety and Performance clinical investigation.
Detailed description
The Amnis Thrombectomy Device is intended to restore blood flow by removing thrombus from intracranial vessels in patients experiencing ischemic stroke. Pre-CE mark clinical investigation. Population will be subjects with documented untreated, acute ischemic stroke with large vessel occlusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open arm | Experimental | Device: Thrombectomy DeviceThrombectomy device to be used to retrieve clot and restore blood flow. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged18-85years.
- Subject who is contraindicated or failed (when the physician withdraws the tPA per physician discretion) intravenous tissue plasminogen activator (t-PA) therapy given at local institutions or within national practice. Failed means that the physician does not continue with IV tPA after thrombolysis; there is still an occlusion with TICI that is </= 1 as the relevant inclusion criteria.
- Subject is able to be treated within 8 hours of stroke symptoms onset with minimum of one deployment of the Amnis Thrombectomy Device.
- NIHSS score ≥8.
- Pre-stroke mRS (modified Rankin Scale) score of 0 to 1.
Key exclusion criteria (27 listed)
- Rapid neurological improvement prior to or at time of treatment suggesting resolution of signs/symptoms of stroke.
- Estimated time of symptom onset.
- Baseline NIHSS score <8.
- BaselineNIHSS score ≥30 or state of coma.
- Baseline pre-stroke mRS score >1.
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 |
|---|---|---|
| Thrombectomy DeviceThe Amnis Thrombectomy Device is intended to restore blood flow by removing thrombus from intracranial vessels in patients experiencing ischemic stroke | Device | Open arm |
Primary outcome
All serious adverse events (notably at 24 hours ± 3 hrs post procedure or until alternative stroke treatment is initiated, whichever comes first).
Time frame: 24 hours ± 3 hrs post procedure or until alternative stroke treatment is initiated, whichever comes first.
It will investigate whether the application of Amnis Thrombectomy device is a safe method, in acute stroke therapy, for obtaining recanalization of large vessels and with favorable patient outcome.
All cause mortality (90 days).
Time frame: 3 months post-procedure
Determine the number of participants with treatment-related adverse events.
3 secondary outcomes
Arterial recanalization of the occluded target vessel in the immediate post-procedure angiogram.
Time frame: Immediate post-procedure angiogram.
Proportion of patients with rapid neurological improvement as determined by a NIHSS ≤4.
Time frame: First 24 hours after treatment
Good functional clinical outcome as determine by a modified Rankin Scale score of 0-2.
Time frame: First 24 hours after treatment.
Results and safety
The study was stopped early (reason given: Subject recruitment problem due to Covid pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- 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.
Tommy Andersson, M.D.; Ph.D. principal investigator
Karolinska Institute, Neuroradiology Clinic, Stockholm, Sweden
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrombectomy Device in people with Ischemic Stroke, run by Amnis Therapeutics at 4 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 8 inclusion and 27 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 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, Sweden. 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: Subject recruitment problem due to Covid pandemic). 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?
All serious adverse events (notably at 24 hours ± 3 hrs post procedure or until alternative stroke treatment is initiated, whichever comes first). (time frame: 24 hours ± 3 hrs post procedure or until alternative stroke treatment is initiated, whichever comes first.). 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 25 Jul 2022.