Enviâ„¢-SR Randomized Controlled Trial for Endovascular Treatment of Ischemic Stroke (NCT05107206) | Clinical Trial Compass
TerminatedNot Applicable
Enviâ„¢-SR Randomized Controlled Trial for Endovascular Treatment of Ischemic Stroke
Stopped: Study was terminated due to management decision. Study was not terminated due to safety reasons.
United States12 participantsStarted 2022-06-23
Plain-language summary
The study objective is to examine and compare clinical outcomes, as measured by Modified Rankin Scale (mRS) at 90 days (± 15 days) post treatment, and related performance characteristics of the Envi™-SR and concurrent parallel Control Devices currently cleared by the U.S. FDA for treatment of stroke.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Clinical signs consistent with acute ischemic stroke
✓. Pre-stroke Modified Rankin Score ≤ 2
✓. Age 18 years and no upper limit (patient must be 18 years old at time of consent).
✓. NIHSS ≥ 6 at the time of randomization
✓. Subject is able to start treatment (defined as time of arterial puncture) within 24 hours of stroke onset or last known well and within 90 minutes from last baseline CT/ MRI.
✓. Imaging: For strokes in the anterior circulation the following imaging criteria should also be met:
✓. If stroke onset (as defined by the time the patient was last seen at baseline) is within 6 hours: Baseline ASPECTS ≥6 on non-contrast CT (NCCT) or DWI-MRI;
✓. If stroke onset is within 6-24 hours, advanced imaging with either CT perfusion or DWI-MRI is required. Baseline infarct volume must be ≤50cc for patients under 80 years old and ≤20cc for patients 80 years or older.
Exclusion criteria
✕. Life expectancy likely less than six (6) months.
✕. Females who are pregnant or breastfeeding.
✕. Known history of severe allergy (more than rash) to contrast medium that cannot be medically controlled.
✕. Suspicion of renal failure (Renal failure as defined by a serum creatinine \>3.0 mg/dL (264 μmol/L) or Glomerular Filtration Rate (eGFR) \<30).
What they're measuring
1
Primary Effectiveness Endpoint: Proportion of Subjects With Good Clinical Outcome Defined as Modified Rankin Score (mRS) of ≤2
Timeframe: 90 days
2
Primary Safety Endpoint: Device-related or Procedure-related Symptomatic Intracranial Hemorrhage (sICH)
✕. Severe, sustained hypertension (Systolic Blood Pressure \>185 mmHg or Diastolic Blood Pressure \>110 mmHg) NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using medication the subject can be enrolled.
✕. Currently participating in another interventional (drug, device, etc.) research project that may confound the results of this study.
✕. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency. (A subject without history or suspicion of coagulopathy does not require INR or prothrombin time lab results to be available prior to enrollment.)
✕. Known history of platelet count \<100,000/μL.