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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
Clinical signs consistent with acute ischemic stroke
Patient was ambulatory prior to stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

ENVI RCT Trial 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.Check my eligibility
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.See study design
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.

ENVI RCT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am showing signs of a recent stroke.
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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 received IV t-PA treatment within 3 hours after my stroke began.
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I was mostly independent before my stroke.
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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 18 years old or older.
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I am showing signs of a recent stroke.
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I was mostly independent before my stroke.

ENVI RCT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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)

ENVI RCT 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

Find a Location

Who is running the clinical trial?

NeuroVasc TechnologiesLead Sponsor
Raul G Nogueira, MDPrincipal InvestigatorUniversity of Pittsburgh Medical Center
17 Previous Clinical Trials
353,219 Total Patients Enrolled
16 Trials studying Stroke
353,019 Patients Enrolled for Stroke
Vitor Mendes-Pereira, MD, MScPrincipal InvestigatorSt Michael's Hospital and the University of Toronto

Media Library

Envi™-SR Thrombectomy device (Mechanical Thrombectomy Device) Clinical Trial Eligibility Overview. Trial Name: NCT05107206 — N/A
Stroke Research Study Groups: Envi™-SR Thrombectomy Device, Solitaire or Trevo Revascularization Device
Stroke Clinical Trial 2023: Envi™-SR Thrombectomy device Highlights & Side Effects. Trial Name: NCT05107206 — N/A
Envi™-SR Thrombectomy device (Mechanical Thrombectomy Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05107206 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Met criteria
~273 spots leftby Dec 2025