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NCT Number: NCT07335185

Gravity Stroke System for Recanalization of Large Vessel Occlusion Strokes

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.

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Key information

Conditions

Stroke Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Infarction Ischemia Ischemic Stroke Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Disease Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

Supernova revascularization device

Device

Mechanical Thrombectomy

Primary outcomes

  1. 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

  2. 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.

  3. All-cause mortality

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

    Safety (All-cause mortality)

Secondary outcomes

  1. Percentage of participants with a modified Rankin Scale (mRS) score of ≤2

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

    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)

  2. Asymptomatic Intracranial Hemorrhage

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

    Incidence of any asymptomatic intracranial hemorrhage post-procedure

  3. Neurological Deterioration

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

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

Sponsors and collaborators

Lead sponsor

Gravity Medical Technology, INC

Industry

Registry information

Acronym: GRASSROOT Reg

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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