Status:
COMPLETED
Safety of RNS60 in Large Vessel Occlusion Stroke Patients Undergoing Endovascular Thrombectomy
Lead Sponsor:
Revalesio Corporation
Conditions:
Stroke, Ischemic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A Phase II, randomized, blinded, placebo-controlled, parallel group study with patients experiencing a large vessel occlusion acute ischemic stroke who are selected for endovascular revascularization....
Detailed Description
This study is a Phase II, randomized, blinded, placebo-controlled, parallel group design. Participants experiencing a large vessel occlusion acute ischemic stroke who are selected for endovascular rev...
Eligibility Criteria
Inclusion
- Acute ischemic stroke (AIS) selected for emergency endovascular treatment.
- Age 18 years or older.
- Onset (last-known-well) time to randomization time within 24 hours.
- Disabling stroke defined as a baseline National Institutes of Health Stroke Score (NIHSS)
- NIHSS \> 5 for internal carotid artery (ICA) and M1-middle cerebral artery (MCA) occlusion or
- NIHSS \> 10 for M2-MCA occlusion.
- Confirmed symptomatic intracranial occlusion at one or more of the following locations: Intracranial carotid I/T/L, M1 or M2 segment MCA. Tandem extracranial carotid and intracranial occlusions are permitted.
- Pre-stroke (24 hours prior to stroke onset) historical modified Rankin Scale (mRS) ≤2. Patient must be living without requiring nursing care.
- Qualifying imaging performed less than 2 hours prior to randomization.
- Consent process completed as per applicable laws and regulation and the IRB requirements.
Exclusion
- Evidence of a large core of established infarction defined as ASPECTS 0-4.
- Evidence of absence of collateral circulation on qualifying imaging (Collateral score of 0 or 1).
- Any evidence of intracranial hemorrhage or mass lesion on the qualifying imaging.
- Planned use of an endovascular device not having approval or clearance by the relevant regulatory authority.
- Endovascular thrombectomy procedure is completed as defined by the presence of arterial access closure.
- Clinical history, past imaging or clinical judgment suggesting that the intracranial occlusion is chronic or there is suspected intracranial dissection such that there is a predicted lack of success with endovascular intervention.
- Estimated or known weight \> 130 kg (287 lbs).
- Known pregnant/lactating female.
- Myocardial infarction within 6 months prior to Screening including non-Q wave MI; Diagnosis of CHF with either:
- current clinical signs and symptoms of ventricular dysfunction (e.g., edema, shortness of breath),
- CHF medication adjustment within the prior 30 days or
- ejection fraction (if report available) of 30% or less measured in the 6 months prior to Screening; as either medically documented or reported by patient or another person considered by the Investigator to be reasonably reliable.
- Known renal impairment defined as requiring renal replacement therapy (hemo- or peritoneal dialysis).
- Inability to have MRI imaging (Non- MR compatible implants or any other foreseeable reason, including claustrophobia)
- Severe or fatal comorbid illness that will prevent improvement or follow up.
- Inability to complete follow-up treatment to Day 90.
- Participation in another clinical trial investigating a drug, medical device, or a medical procedure in the 30 days preceding trial inclusion and throughout the duration of the trial.
- Reported known seizure at time of stroke onset.
- Ischemic stroke within previous 30 days.
- Patients in normal sinus rhythm with a known QTcF \> 450 ms at Screening.
- Any other symptom that in the investigator's opinion may complicate or preclude the subject from participating in this trial.
Key Trial Info
Start Date :
July 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2023
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04693715
Start Date
July 7 2021
End Date
November 8 2023
Last Update
February 7 2024
Active Locations (7)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
Oregon Health & Science University
Portland, Oregon, United States, 97239
3
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
4
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107