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

Gravity Medical Technology

Status: Not yet enrolling

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

Treatments: Device: Supernova revascularization device

Study type: Interventional

Funder types: Industry

Identifiers

NCT07335185

GMT-GRASSROOT-2026-01

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,000 participants in 1 patient group

Supernova revascularization device

Experimental group

Description:

Mechanical thrombectomy with Supernova Stent Retriever

Treatment:

Device: Supernova revascularization device