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Not yet recruitingNCT07335185GRASSROOT RegUpdated Jan 13, 2026

Gravity Stroke System for Recanalization of Large Vessel Occlusion Strokes

An interventional study of Supernova revascularization device in Stroke, Ischemic Stroke and Cerebrovascular Disorders, sponsored by Gravity Medical Technology, INC. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-01-13.

Primary conditionIschemic StrokeRegistry: StrokeReclassifiedWhy we changed it
Registry
Stroke — the first condition term the registry derived for this study.
ClinicalTrials.gg
Ischemic Stroke
Why
  1. The study's listed conditions name Ischemic Stroke, a narrower term within Stroke.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Gravity Medical Technology, INC · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
3,000
Allocation
Not applicable
Sex
All
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Study 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.

02

Conditions studied

  • Stroke
  • Ischemic Stroke
  • Cerebrovascular Disorders
  • Brain Diseases
  • Central Nervous System Diseases
  • Nervous System Diseases
  • Vascular Disease

Keywords

  • Mechanical Thrombectomy
  • Brain
  • Brain Clot
  • Cerebral Ischemia
  • Brain Infarction
  • Neurovascular Intervention
  • Revascularization
  • Reperfusion
  • Stent Retriever
  • Supernova
  • Stroke
  • Gravity Medical Technology
03

In context

Ischemic Stroke Reclassified

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Gravity Medical Technology, INC is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Compared within Ischemic Stroke, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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.
  2. Subject has been or will be treated with Supernova and/or Neutron devices as the initial device used to remove the thrombus
  3. Subject is willing to participate in a 90-day follow-up visit.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3,000 participants (estimated)

Study arms

  • Experimental
    Supernova revascularization device

    Mechanical thrombectomy with Supernova Stent Retriever

    Device: Supernova revascularization device

Interventions

  • DeviceSupernova revascularization device

    Mechanical Thrombectomy

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 0 (end of procedure)

  2. 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.

    Time frame: sICH measured within 24 (18-36) hours of the procedure

  3. All-cause mortality

    Safety (All-cause mortality)

    Time frame: All-cause mortality measured at 90 (±14) days

Secondary outcomes

  1. 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)

    Time frame: 90 (±14) days post-treatment

  2. Asymptomatic Intracranial Hemorrhage

    Incidence of any asymptomatic intracranial hemorrhage post-procedure

    Time frame: Day 1 (within 24 hours (18-36 hours) of the procedure)

  3. Neurological Deterioration

    Safety (defined as a ≥4-point increase in the National Institutes of Health Stroke Scale (NIHSS) score)

    Time frame: Day 1 (within 24 hours (18-36 hours) of the procedure)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2026; primary completion for Oct 2030, 57 months later.

Of 81 industry-sponsored interventional studies with no phase under Ischemic Stroke, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 46. This study's planned 57 months is above that.

Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 5, 2026
First posted
Jan 13, 2026
StartEst.
Jan 1, 2026
Primary completionEst.
Oct 31, 2030
CompletionEst.
Dec 31, 2030
Last update
Jan 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07335185
Lead sponsor
Gravity Medical Technology, INC
Responsible party
Sponsor
First posted
Jan 13, 2026
Start date
Jan 1, 2026 (estimated)
Primary completion
Oct 31, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Jan 13, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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