Gravity Stroke System for Recanalization of Large Vessel Occlusion Strokes

NCT07335185 | Not Yet Recruiting DMC

• 1 other identifier: GMT-GRASSROOT-2026-01
• Study Type: interventional
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

  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.

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

• All-cause mortality

  Safety (All-cause mortality)

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

Secondary Outcomes (3)

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

  90 (±14) days post-treatment

• Asymptomatic Intracranial Hemorrhage

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

• Neurological Deterioration

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

Study Arms (1)

Supernova revascularization device

EXPERIMENTAL

Mechanical thrombectomy with Supernova Stent Retriever

Device: Supernova revascularization device

Interventions

Supernova revascularization device DEVICE

Mechanical Thrombectomy

Supernova revascularization device

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gravity Medical Technology, INC: lead

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Brain Ischemia; Brain Infarction

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 13, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share