Gravity Stroke System for Recanalization of Large Vessel Occlusion Strokes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2030-12-31

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Supernova revascularization device

Mechanical thrombectomy with Supernova Stent Retriever

Group Type EXPERIMENTAL

Supernova revascularization device

Intervention Type DEVICE

Mechanical Thrombectomy

Interventions

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Supernova revascularization device

Mechanical Thrombectomy

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No