Gravity Stroke System for Recanalization of Large Vessel Occlusion Strokes

N/ANot Yet RecruitingNCT07335185

Gravity Medical Technology, INC3,000 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

3,000

Conditions

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 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.

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

All-cause mortality

Safety (All-cause mortality)

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

Secondary Outcomes

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

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)

Time frame: 90 (±14) days post-treatment

Asymptomatic Intracranial Hemorrhage

Incidence of any asymptomatic intracranial hemorrhage post-procedure

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

Neurological Deterioration

Safety (defined as a ≥4-point increase in the National Institutes of Health Stroke Scale (NIHSS) score)