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Not yet recruiting NCT07335185

Gravity Stroke System for Recanalization of Large Vessel Occlusion Strokes

No phase Interventional Stroke Ischemic Stroke Cerebrovascular Disorders Brain Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Supernova revascularization device.
Who it may be relevant to
Registry conditions: Stroke, Ischemic Stroke, Cerebrovascular Disorders, Brain Diseases. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Supernova revascularization device
    Mechanical Thrombectomy

Primary outcome measures

  • Successful reperfusion [Time frame: Day 0 (end of procedure)]
  • Symptomatic intracranial hemorrhage [Time frame: sICH measured within 24 (18-36) hours of the procedure]
  • All-cause mortality [Time frame: All-cause mortality measured at 90 (±14) days]
Secondary outcome measures (3)
  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07335185 · GMT-GRASSROOT-2026-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗