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Envi™-SR Thrombectomy Device for Ischemic Stroke (ENVI RCT Trial)
ENVI RCT Trial Summary
This trial will compare two devices used to treat stroke, looking at how well they work and any side effects.
ENVI RCT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowENVI RCT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ENVI RCT Trial Design
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Who is running the clinical trial?
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- I am currently in a coma.You are not expected to live for more than six months.I am showing signs of a recent stroke.I have blockages in multiple blood vessels.My stroke symptoms improved quickly before joining the study.You have signs of a stroke in the front part of your brain as shown on imaging tests.I was able to walk on my own before having a stroke.I have high blood pressure that is difficult to control.There is evidence of a tear in the arteries inside or outside the brain.I am not pregnant or breastfeeding.I have a known bleeding disorder.My brain scan shows significant pressure due to a tumor.I received IV t-PA treatment promptly when needed.I received IV t-PA treatment within 3 hours after my stroke began.I had a stroke or mini-stroke in the last 3 months.I was mostly independent before my stroke.I can start treatment within 24 hours of my stroke or since I was last well, and within 90 minutes of my last brain scan.I have a blockage in a major blood vessel that needs treatment or blocks access to the treatment site.You have a brain tumor shown on a recent CT or MRI scan.I am 18 years old or older.There is a visible sign of bleeding on a CT scan or MR imaging.My cancer has spread to other parts of my body.Your blood has had a low platelet count in the past.Your doctor has confirmed that specific arteries are blocked using angiography.I might have a tear in the wall of my heart's main artery.You are allergic to nickel-titanium.I might have a serious infection like bacterial endocarditis.Your stroke severity score is 6 or higher when you join the study.I do not have any neurological or psychiatric conditions that could affect my brain function tests.Your blood sugar levels are very low (<50mg/dL) or very high (>400mg/dL).I haven't had any clot removal or artery treatments in the last 3 months.I have not had recent bleeding in my brain or a burst blood vessel.I had seizures when I first had a stroke.My blood vessels are too twisted for certain medical procedures.I might have kidney problems.I might have brain vessel inflammation, as suggested by my history and brain scans.I am showing signs of a recent stroke.I was mostly independent before my stroke.
- Group 1: Envi™-SR Thrombectomy Device
- Group 2: Solitaire or Trevo Revascularization Device
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
In what locations can one access this experiment?
"At present, 4 medical centers are offering this trial: Providence Medical Foundation in Irvine, Advocate Aurora Health in Downers Grove, and North Shore University Hospital in Manhasset. Additionally, there are several other locations available."
What is the aggregate figure of participants involved in this clinical experiment?
"To properly execute this clinical trial, 560 qualified patients must join the study. NeuroVasc Technologies is supervising the research from various centres such as Providence Medical Foundation in Irvine and Advocate Aurora Health in Downers Grove, Illinois."
Are there any available slots for individuals to join this research project?
"Affirmative. Clinicaltrials.gov displays information which reveals that this medical trial commenced on June 23rd 2022 and was recently amended on September 15th 2022, with the aim of recruiting 560 patients from 4 healthcare centres."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
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