Gravity Stroke System for Recanalization of Large Vessel Occlusion Strokes (GRASSROOT Reg)

January 5, 2026 updated by: Gravity Medical Technology, INC
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

3000

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supernova revascularization device
Mechanical thrombectomy with Supernova Stent Retriever
Device: Supernova revascularization device
Mechanical Thrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0 (end of procedure)
All-cause mortality
Time Frame: All-cause mortality measured at 90 (±14) days
Safety (All-cause mortality)
All-cause mortality measured at 90 (±14) days
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.
sICH measured within 24 (18-36) hours of the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
90 (±14) days post-treatment
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)
Day 1 (within 24 hours (18-36 hours) of the procedure)
Asymptomatic Intracranial Hemorrhage
Time Frame: Day 1 (within 24 hours (18-36 hours) of the procedure)
Incidence of any asymptomatic intracranial hemorrhage post-procedure
Day 1 (within 24 hours (18-36 hours) of the procedure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gravity Medical Technology, INC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

October 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMT-GRASSROOT-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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