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

Part of paid clinical trials in Irvine, California.

Sponsor
NeuroVasc Technologies
Study ID
NCT05107206
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mechanical Thrombectomy using the Envi™-SR Thrombectomy device — DEVICE
    Clot removal using the Envi™-SR Thrombectomy device
  • Mechanical Thrombectomy using the Solitaire or Trevo Revascularization Device — DEVICE
    Clot removal using the Solitaire or Trevo Revascularization Device

Study Details

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.

Key Dates

Start date
Jun 23, 2022
Status verified
Apr 2026
Primary completion
May 18, 2023
Completion
Jan 27, 2025

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Envi™-SR Thrombectomy Device
    Mechanical Thrombectomy using the Envi™-SR Thrombectomy Device
  • Active Comparator: Solitaire or Trevo Revascularization Device
    Mechanical Thrombectomy using the Solitaire or Trevo Revascularization Device

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 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Providence Medical FoundationIrvineCalifornia92612-
Baptist Health Research InstituteJacksonvilleFlorida32207-
Advocate Aurora HealthDowners GroveIllinois60068-
North Shore University HospitalManhassetNew York11030-

Find similar trials in Irvine, CA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Providence Medical Foundation· Irvine, CABaptist Health Research Institute· Jacksonville, FLAdvocate Aurora Health· Downers Grove, ILNorth Shore University Hospital· Manhasset, NY

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