Envi™-SR Randomized Controlled Trial for Endovascular Treatment of Ischemic Stroke

NCT05107206 | Terminated Results DMC FDA Device

• 1 other identifier: CL-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• 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)

  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)).

  24 hours

Secondary Outcomes (3)

• Secondary Effectiveness Endpoint: Proportion of Subjects With Early Response (NIHSS)

  7 days (-2/+3 days) or discharge

• Secondary Effectiveness Endpoint: Proportion of Subjects Who Achieve Successful Reperfusion Measured Using eTICI

  Procedure through final angiographic assessment

• Secondary Effectiveness Endpoint: Proportion of Subjects Achieving First Pass Effect (FPE)

  Procedure through final angiographic assessment

Study Arms (2)

Envi™-SR Thrombectomy Device

EXPERIMENTAL

Mechanical Thrombectomy using the Envi™-SR Thrombectomy Device

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

Device: Mechanical Thrombectomy using the Solitaire or Trevo Revascularization Device

Interventions

Mechanical Thrombectomy using the Envi™-SR Thrombectomy device DEVICE

Clot removal using the Envi™-SR Thrombectomy device

Envi™-SR Thrombectomy Device

Mechanical Thrombectomy using the Solitaire or Trevo Revascularization Device DEVICE

Clot removal using the Solitaire or Trevo Revascularization Device

Solitaire or Trevo Revascularization Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NeuroVasc Technologies: lead

Study Sites (4)

Providence Medical Foundation

Irvine, California, 92612, United States

Location

Baptist Health Research Institute

Jacksonville, Florida, 32207, United States

Location

Advocate Aurora Health

Downers Grove, Illinois, 60068, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

This study was limited by a small sample size and was not powered for formal statistical comparisons between treatment groups. Analyses were descriptive in nature.

Results Point of Contact

• Title: Edgar Trejo Gimenez, Sr. Manager Global Regulatory Affairs
• Organization: Neurovasc Technologies Inc.

Edgar.trejogimenez@neurovasctechnologies.com

9498223143

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: a prospective, multinational, randomized (adaptive), parallel group controlled, blinded, non-inferiority study.

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 4, 2021
• Study Start: June 23, 2022
• Primary Completion: May 18, 2023
• Study Completion: January 27, 2025
• Last Updated: April 27, 2026
• Results First Posted: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)