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

Not Applicable

Terminated

• Conditions: Acute Ischemic Stroke
• Interventions: Device: Mechanical Thrombectomy using the Envi™-SR Thrombectomy device; Device: Mechanical Thrombectomy using the Solitaire or Trevo Revascularization Device

• Registration Number: NCT05107206
• Lead Sponsor: NeuroVasc Technologies

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.

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 Timeline

• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-11-04
• Study Start: 2022-06-23
• Primary Completion: 2023-05-18
• Study Completion: 2025-01-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Envi™-SR Thrombectomy Device	Mechanical Thrombectomy using the Envi™-SR Thrombectomy device	Mechanical Thrombectomy using the Envi™-SR Thrombectomy Device
Solitaire or Trevo Revascularization Device	Mechanical Thrombectomy using the Solitaire or Trevo Revascularization Device	Mechanical Thrombectomy using the Solitaire or Trevo Revascularization Device

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Endpoint: Proportion of subjects with good clinical outcome defined as Modified Rankin Score (mRS) of ≤2	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)	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)).

Trial Locations

Locations (4)

Providence Medical Foundation; 🇺🇸 Irvine, California, United States

Baptist Health Research Institute; 🇺🇸 Jacksonville, Florida, United States

Advocate Aurora Health; 🇺🇸 Downers Grove, Illinois, United States

North Shore University Hospital; 🇺🇸 Manhasset, New York, United States