StrokeGRASSROOT RegNCT07335185
Gravity Stroke System for Recanalization of Large Vessel Occlusion Strokes
A study testing Supernova revascularization device in people with Stroke and Ischemic Stroke, run by Gravity Medical Technology, INC.
Trial summary
Supernova and Neutron are endovascular mechanical revascularization devices indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing an acute ischemic stroke within 24 hours of symptom onset or from last known well time. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Ischemic Stroke, Cerebrovascular Disorders
- What is being tested?
- Supernova revascularization device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject has experienced an Acute Ischemic Stroke due to large intracranial vessel occlusion in at least one of the following intracranial vessels: internal carotid artery (ICA), M1and M2 segments of the middle cerebral artery (MCA), basilar, and vertebral artery.
- Subject has been or will be treated with Supernova and/or Neutron devices as the initial device used to remove the thrombus
- Subject is willing to participate in a 90-day follow-up visit.
Who cannot join
- Concurrent participation in another mechanical neurothrombectomy device trial or any other clinical trial with an active treatment arm where the study procedure or treatment might confound the results of the registry.
About this study
Supernova and Neutron are endovascular mechanical revascularization devices indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing an acute ischemic stroke within 24 hours of symptom onset or from last known well time.
- Conditions
- Stroke, Ischemic Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
- Being tested
- Supernova revascularization device
- Keywords
- Mechanical Thrombectomy, Brain, Brain Clot, Cerebral Ischemia, Brain Infarction, Neurovascular Intervention, Revascularization, Reperfusion, Stent Retriever, Supernova, Stroke, Gravity Medical Technology
- Medical subject headings
- Stroke, Ischemic Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supernova revascularization deviceDevice
Mechanical Thrombectomy
| Study group | Role | What they receive |
|---|---|---|
| Supernova revascularization device | Experimental | Mechanical thrombectomy with Supernova Stent Retriever Receives: Device: Supernova revascularization device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful reperfusion
Rate of successful reperfusion, defined as modified Thrombolysis in Cerebral Ischemia (mTICI) grade of 2b or higher
Grade 0: No reperfusion Grade 3: Complete reperfusion
Measured: Day 0 (end of procedure)
Symptomatic intracranial hemorrhage
Safety (Rate of symptomatic intracranial hemorrhage (sICH) as measured by the SITS-MOST criteria) The SITS-MOST definition of SICH is a local or remote type II parenchymal haemorrhage within 22 to 36 hours after treatment (or sooner) associated with a ≥ fourpoint deterioration on the NIHSS score from baseline or from the lowest score from baseline to 24 hours, or leading to death.
Measured: sICH measured within 24 (18-36) hours of the procedure
All-cause mortality
Safety (All-cause mortality)
Measured: All-cause mortality measured at 90 (±14) days
Secondary outcomes (3)
Percentage of participants with a modified Rankin Scale (mRS) score of ≤2
Effectiveness
(The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.
Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.
Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
Score 6: Dead)
Measured: 90 (±14) days post-treatment
Asymptomatic Intracranial Hemorrhage
Incidence of any asymptomatic intracranial hemorrhage post-procedure
Measured: Day 1 (within 24 hours (18-36 hours) of the procedure)
Neurological Deterioration
Safety (defined as a ≥4-point increase in the National Institutes of Health Stroke Scale (NIHSS) score)
Measured: Day 1 (within 24 hours (18-36 hours) of the procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Oct 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gravity Medical Technology, INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335185
- Sponsor's protocol ID
- GMT-GRASSROOT-2026-01
- Acronym
- GRASSROOT Reg
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 13 Jan 2026
- 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 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gravity Stroke System for Recanalization of Large Vessel Occlusion Strokes
- ClinicalTrials.gov ID
- NCT07335185
- Acronym / sponsor ID
- GRASSROOT Reg / GMT-GRASSROOT-2026-01
- Conditions
- Stroke, Ischemic Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
- Keywords
- Mechanical Thrombectomy, Brain, Brain Clot, Cerebral Ischemia, Brain Infarction, Neurovascular Intervention, Revascularization, Reperfusion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Gravity Medical Technology, INCIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Oct 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 13 Jan 2026 (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.
Supernova and Neutron are endovascular mechanical revascularization devices indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing an acute ischemic stroke within 24 hours of symptom onset or from last known well time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supernova revascularization device | Experimental | Device: Supernova revascularization deviceMechanical thrombectomy with Supernova Stent Retriever |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subject has experienced an Acute Ischemic Stroke due to large intracranial vessel occlusion in at least one of the following intracranial vessels: internal carotid artery (ICA), M1and M2 segments of the middle cerebral artery (MCA), basilar, and vertebral artery.
- Subject has been or will be treated with Supernova and/or Neutron devices as the initial device used to remove the thrombus
- Subject is willing to participate in a 90-day follow-up visit.
Key exclusion criteria (1 listed)
- Concurrent participation in another mechanical neurothrombectomy device trial or any other clinical trial with an active treatment arm where the study procedure or treatment might confound the results of the registry.
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 |
|---|---|---|
| Supernova revascularization deviceMechanical Thrombectomy | Device | Supernova revascularization device |
Primary outcome
Successful reperfusion
Time frame: Day 0 (end of procedure)
Rate of successful reperfusion, defined as modified Thrombolysis in Cerebral Ischemia (mTICI) grade of 2b or higher Grade 0: No reperfusion Grade 3: Complete reperfusion
Symptomatic intracranial hemorrhage
Time frame: sICH measured within 24 (18-36) hours of the procedure
Safety (Rate of symptomatic intracranial hemorrhage (sICH) as measured by the SITS-MOST criteria) The SITS-MOST definition of SICH is a local or remote type II parenchymal haemorrhage within 22 to 36 hours after treatment (or sooner) associated with a ≥ fourpoint deterioration on the NIHSS score from baseline or from the lowest score from baseline to 24 hours, or leading to death.
All-cause mortality
Time frame: All-cause mortality measured at 90 (±14) days
Safety (All-cause mortality)
3 secondary outcomes
Percentage of participants with a modified Rankin Scale (mRS) score of ≤2
Time frame: 90 (±14) days post-treatment
Asymptomatic Intracranial Hemorrhage
Time frame: Day 1 (within 24 hours (18-36 hours) of the procedure)
Neurological Deterioration
Time frame: Day 1 (within 24 hours (18-36 hours) of the procedure)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Supernova revascularization device in people with Stroke and Ischemic Stroke, run by Gravity Medical Technology, INC.
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Successful reperfusion (time frame: Day 0 (end of procedure)). The study lists 3 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 13 Jan 2026.