- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05107206
Envi™-SR Randomized Controlled Trial for Endovascular Treatment of Ischemic Stroke (ENVI RCT)
September 15, 2022 updated by: NeuroVasc Technologies
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.
Study Overview
Status
Recruiting
Conditions
Detailed Description
This study intends to evaluate a novel mechanical thrombectomy device to treat patients suffering from acute ischemic stroke through a prospective, randomized pivotal study to provide an assessment of the safety and non-inferiority of the device.
Study Type
Interventional
Enrollment (Anticipated)
560
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: NeuroVasc Clinical Affairs
- Phone Number: 949-258-9946
- Email: clinical@neurovasctechnologies.com
Study Locations
-
-
California
-
Irvine, California, United States, 92612
- Not yet recruiting
- Providence Medical Foundation
-
Contact:
- Radoslav Raychev, MD
- Email: rudoray@gmail.com
-
Contact:
- Lan Nguyen
- Phone Number: 714-912-6768
- Email: lan.n.nguyen@providence.org
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-
Florida
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Jacksonville, Florida, United States, 32207
- Recruiting
- Baptist Health Research Institute
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Contact:
- Amin Aghaebrahim, MD
- Email: amin.aghaebrahim@bmcjax.com
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Contact:
- LaNaya Lewis
- Phone Number: 904-202-7013
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-
Illinois
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Downers Grove, Illinois, United States, 60068
- Recruiting
- Advocate Aurora Health
-
Contact:
- Demetrius Lopes, MD
- Email: Demetrius.Lopes@advocatehealth.com
-
Contact:
- Nicholas Armijo
- Phone Number: 773-317-9512
- Email: nicholas.armijo@aah.org
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-
New York
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Manhasset, New York, United States, 11030
- Not yet recruiting
- North Shore University Hospital
-
Contact:
- Athos Patsalides, MD
- Email: apatsalides@northwell.edu
-
Contact:
- Betsy Moclair
- Phone Number: 917-673-4908
- Email: bmoclair@northwell.edu
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
- Location: Angiographic confirmation of an occlusion of an ICA (including T or L occlusions), M1 or M2 MCA, with eTICI flow of zero (0) - one (1).
- Patients for whom IV t-PA is indicated are treated with IV t-PA without delay.
- IV t-PA, if used, is initiated within three (3) hours of stroke onset (onset time is defined as the last time when the patient was witnessed to be at baseline), with investigator verification that the subject has received/is receiving the correct IV t-PA dose for the estimated weight.
- Consent: The patient or the patient's legally authorized representative (LAR) has signed and dated an Informed Consent Form.
- Will comply with protocol follow-up schedule.
- Patient was ambulatory prior to stroke, i.e. able to walk without another person's assistance.
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).
- 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.
- Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol).
- Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
- CT or MR evidence of hemorrhage.
- Seizures at stroke onset.
- Suspicion of aortic dissection.
- Patients with known hypersensitivity to nickel-titanium.
- Evidence of dissection in the extra or intracranial cerebral arteries.
- Stenosis, or any occlusion, in a proximal vessel that requires treatment or prevents access to the site of occlusion.
- Presumed septic embolus, suspicion of bacterial endocarditis, or other serious infection.
- Suspected cerebral vasculitis based on medical history and CTA/Magnetic Resonance Angiogram (MRA).
- Excessive vascular access tortuosity that will likely prevent endovascular access.
- Baseline CT or Magnetic Resonance Imaging (MRI) showing intracranial tumor (except asymptomatic small meningiomas less than three (3) cm).
- Significant mass effect with midline shift
- Treatment with any cleared thrombectomy devices or other intra-arterial (neurovascular) therapies three months prior to use of treatment device
- Unlikely to be available for 90-day (± 15 days) follow-up (e.g. no fixed home address, visitor from overseas).
- Rapid neurological improvement prior to study enrollment suggesting resolution of signs/symptoms of stroke such as a decrease that leads to an NIHSS below the study cut-off of six (6).
- Patient has suffered a hemorrhagic or ischemic stroke or TIA in at least the last three (3) months.
- Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, mRS score at baseline must be ≤ 2. This excludes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.).
- Known cancer with metastases.
- Subject currently uses or has a recent history of illicit drug(s), which includes marijuana.
- Recent past history (within three (3) months) or clinical presentation of intracranial hemorrhage (ICH), subarachnoid hemorrhage (SAH), ruptured arteriovenous malformation (AVM) or ruptured aneurysm.
- The patient is in a coma.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Envi™-SR Thrombectomy Device
Mechanical Thrombectomy using the Envi™-SR Thrombectomy Device
|
Clot removal using the Envi™-SR Thrombectomy device
|
Active Comparator: Solitaire or Trevo Revascularization Device
Mechanical Thrombectomy using the Solitaire or Trevo Revascularization Device
|
Clot removal using the Solitaire or Trevo Revascularization Device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Effectiveness Endpoint: Proportion of subjects with good clinical outcome defined as Modified Rankin Score (mRS) of ≤2
Time Frame: 90 days
|
The proportion of subjects with good clinical outcome defined as Modified Rankin Score (mRS) of ≤2 as assessed by a blinded assessor at 90 days (± 15 days).
|
90 days
|
Primary Safety Endpoint: Device-related or procedure-related symptomatic intracranial hemorrhage (sICH)
Time Frame: 24 hours
|
Device-related or procedure-related symptomatic intracranial hemorrhage (sICH) defined by the Heidelberg Bleeding Classification at 24 hours (-8/+12 hours) (as read by the Core Lab and adjudicated by Clinical Events Committee (CEC)).
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Vitor Mendes-Pereira, MD, MSc, St Michael's Hospital and the University of Toronto
- Principal Investigator: Raul G Nogueira, MD, University of Pittsburgh Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 23, 2022
Primary Completion (Anticipated)
December 1, 2025
Study Completion (Anticipated)
December 1, 2025
Study Registration Dates
First Submitted
October 21, 2021
First Submitted That Met QC Criteria
October 25, 2021
First Posted (Actual)
November 4, 2021
Study Record Updates
Last Update Posted (Actual)
September 16, 2022
Last Update Submitted That Met QC Criteria
September 15, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CL-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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