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Mechanical Thrombectomy Device
Envi™-SR Thrombectomy Device for Ischemic Stroke (ENVI RCT Trial)
N/A
Recruiting
Led By Raul G Nogueira, MD
Research Sponsored by NeuroVasc Technologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient was ambulatory prior to stroke
Patients for whom IV t-PA is indicated are treated with IV t-PA without delay
Must not have
The patient is in a coma
Subjects with occlusions in multiple vascular territories
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare two devices used to treat stroke, looking at how well they work and any side effects.
Who is the study for?
This trial is for adults who've had a recent ischemic stroke, can walk independently (pre-stroke mRS ≤ 2), and have an NIHSS score of at least 6. They must be able to start treatment within 24 hours of the stroke and follow the study schedule. Exclusions include pregnancy, severe allergies to contrast media, other recent strokes or interventions, drug abuse, certain blood conditions, and life expectancy under six months.
What is being tested?
The trial compares two mechanical thrombectomy devices: Envi™-SR versus FDA-cleared control devices like Solitaire or Trevo. It aims to see which device better improves patient outcomes using the Modified Rankin Scale after three months from treatment in patients with arterial blockages due to stroke.
What are the potential side effects?
Possible side effects may include bleeding complications, allergic reactions to contrast media used during the procedure (if not controlled medically), vessel damage from device insertion or operation, risk of infection post-procedure, and potential for kidney issues related to dye use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was able to walk on my own before having a stroke.
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I received IV t-PA treatment promptly when needed.
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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.
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I am showing signs of a recent stroke.
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I was mostly independent before my stroke.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently in a coma.
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I have blockages in multiple blood vessels.
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I have high blood pressure that is difficult to control.
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I am not pregnant or breastfeeding.
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I have a known bleeding disorder.
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My brain scan shows significant pressure due to a tumor.
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I have a blockage in a major blood vessel that needs treatment or blocks access to the treatment site.
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My cancer has spread to other parts of my body.
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I might have a tear in the wall of my heart's main artery.
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I might have a serious infection like bacterial endocarditis.
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I do not have any neurological or psychiatric conditions that could affect my brain function tests.
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I have not had recent bleeding in my brain or a burst blood vessel.
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I had seizures when I first had a stroke.
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My blood vessels are too twisted for certain medical procedures.
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I might have kidney problems.
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I might have brain vessel inflammation, as suggested by my history and brain scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Effectiveness Endpoint: Proportion of subjects with good clinical outcome defined as Modified Rankin Score (mRS) of ≤2
Primary Safety Endpoint: Device-related or procedure-related symptomatic intracranial hemorrhage (sICH)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Envi™-SR Thrombectomy DeviceExperimental Treatment1 Intervention
Mechanical Thrombectomy using the Envi™-SR Thrombectomy Device
Group II: Solitaire or Trevo Revascularization DeviceActive Control1 Intervention
Mechanical Thrombectomy using the Solitaire or Trevo Revascularization Device
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Who is running the clinical trial?
NeuroVasc TechnologiesLead Sponsor
Raul G Nogueira, MDPrincipal InvestigatorUniversity of Pittsburgh Medical Center
17 Previous Clinical Trials
353,326 Total Patients Enrolled
16 Trials studying Stroke
353,126 Patients Enrolled for Stroke
Vitor Mendes-Pereira, MD, MScPrincipal InvestigatorSt Michael's Hospital and the University of Toronto
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently in a coma.You are not expected to live for more than six months.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 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.
Research Study Groups:
This trial has the following groups:- Group 1: Solitaire or Trevo Revascularization Device
- Group 2: Envi™-SR Thrombectomy Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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