Acute Ischemic StrokeENVI RCTNCT05107206
Envi™-SR Randomized Controlled Trial for Endovascular Treatment of Ischemic Stroke
A study testing Mechanical Thrombectomy using the Envi™-SR Thrombectomy device and Mechanical Thrombectomy using the Solitaire or Trevo Revascularization Device in people with Acute Ischemic Stroke, run by NeuroVasc Technologies at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Mechanical Thrombectomy using the Envi™-SR Thrombectomy device and Mechanical Thrombectomy using the Solitaire or Trevo Revascularization Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Jun 2022to 27 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Show all 30Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Advocate Aurora Health
Downers Grove, Illinois, 60068
Providence Medical Foundation
Irvine, California, 92612
Baptist Health Research Institute
Jacksonville, Florida, 32207
North Shore University Hospital
Manhasset, New York, 11030
About this study
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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Mechanical Thrombectomy using the Envi™-SR Thrombectomy device, Mechanical Thrombectomy using the Solitaire or Trevo Revascularization Device
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Thrombectomy using the Envi™-SR Thrombectomy deviceDevice
Clot removal using the Envi™-SR Thrombectomy device
Mechanical Thrombectomy using the Solitaire or Trevo Revascularization DeviceDevice
Clot removal using the Solitaire or Trevo Revascularization Device
| Study group | Role | What they receive |
|---|---|---|
| Envi™-SR Thrombectomy Device | Experimental | Mechanical Thrombectomy using the Envi™-SR Thrombectomy Device Receives: Device: Mechanical Thrombectomy using the Envi™-SR Thrombectomy device |
| Solitaire or Trevo Revascularization Device | Active comparator | Mechanical Thrombectomy using the Solitaire or Trevo Revascularization Device Receives: Device: Mechanical Thrombectomy using the Solitaire or Trevo Revascularization Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint: Proportion of Subjects With Good Clinical Outcome Defined as Modified Rankin Score (mRS) of ≤2
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)
Measured: 90 days
Primary Safety Endpoint: Device-related or Procedure-related Symptomatic Intracranial Hemorrhage (sICH)
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)).
Measured: 24 hours
Secondary outcomes (3)
Secondary Effectiveness Endpoint: Proportion of Subjects With Early Response (NIHSS)
Early Response is defined as a decrease of ≥10 points in NIHSS from baseline or NIHSS score of 0 or 1 at 7 days (-2/+3 days) or discharge, whichever occurs first.
Measured: 7 days (-2/+3 days) or discharge
Secondary Effectiveness Endpoint: Proportion of Subjects Who Achieve Successful Reperfusion Measured Using eTICI
Successful reperfusion is defined as achieving an expanded Thrombolysis in Cerebrovascular Infarction (eTICI) score of 2b50 or greater in the target vessel following three or less passes of the randomized device.
Measured: Procedure through final angiographic assessment
Secondary Effectiveness Endpoint: Proportion of Subjects Achieving First Pass Effect (FPE)
First Pass Effect (FPE) is defined as achieving an expanded Thrombolysis in Cerebrovascular Infarction (eTICI) score of 2c or greater following a single pass of the randomized device.
Measured: Procedure through final angiographic assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start23 Jun 2022
- Primary completion18 May 2023
- Study completion27 Jan 2025
Why it stopped: Study was terminated due to management decision. Study was not terminated due to safety reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a prospective, multinational, randomized (adaptive), parallel group controlled, blinded, non-inferiority study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroVasc Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vitor Mendes-Pereira, MD, MSc, Principal investigator, St Michael's Hospital and the University of TorontoRaul G Nogueira, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107206
- Sponsor's protocol ID
- CL-001
- Acronym
- ENVI RCT
- Status last verified
- Apr 2026
- First submitted
- 21 Oct 2021
- Last updated
- 27 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Envi™-SR Randomized Controlled Trial for Endovascular Treatment of Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05107206
- Acronym / sponsor ID
- ENVI RCT / CL-001
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to management decision. Study was not terminated due to safety reasons.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- NeuroVasc TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 4 Nov 2021 (actual)
- Results
- Posted 27 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- a prospective, multinational, randomized (adaptive), parallel group controlled, blinded, non-inferiority study.
| Arm | Type | Receives |
|---|---|---|
| Envi™-SR Thrombectomy Device | Experimental | Device: Mechanical Thrombectomy using the Envi™-SR Thrombectomy deviceMechanical Thrombectomy using the Envi™-SR Thrombectomy Device |
| Solitaire or Trevo Revascularization Device | Active comparator | Device: Mechanical Thrombectomy using the Solitaire or Trevo Revascularization DeviceMechanical Thrombectomy using the Solitaire or Trevo Revascularization Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical Thrombectomy using the Envi™-SR Thrombectomy deviceClot removal using the Envi™-SR Thrombectomy device | Device | Envi™-SR Thrombectomy Device |
| Mechanical Thrombectomy using the Solitaire or Trevo Revascularization DeviceClot removal using the Solitaire or Trevo Revascularization Device | Device | Solitaire or Trevo Revascularization Device |
Primary outcome
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)
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)).
3 secondary outcomes
Secondary Effectiveness Endpoint: Proportion of Subjects With Early Response (NIHSS)
Time frame: 7 days (-2/+3 days) or discharge
Secondary Effectiveness Endpoint: Proportion of Subjects Who Achieve Successful Reperfusion Measured Using eTICI
Time frame: Procedure through final angiographic assessment
Secondary Effectiveness Endpoint: Proportion of Subjects Achieving First Pass Effect (FPE)
Time frame: Procedure through final angiographic assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vitor Mendes-Pereira, MD, MSc principal investigator
St Michael's Hospital and the University of Toronto
Raul G Nogueira, MD principal investigator
University of Pittsburgh Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Thrombectomy using the Envi™-SR Thrombectomy device and Mechanical Thrombectomy using the Solitaire or Trevo Revascularization Device in people with Acute Ischemic Stroke, run by NeuroVasc Technologies at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint: Proportion of Subjects With Good Clinical Outcome Defined as Modified Rankin Score (mRS) of ≤2 (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.