The Imperative Trial: Treatment of Acute Ischemic Stroke With the Zoom Reperfusion System

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Imperative Care, Inc.
Study ID
NCT04129125
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Zoom Reperfusion System — DEVICE
    Thrombectomy

Study Details

The trial is designed to assess the safety and efficacy of using the Zoom Reperfusion System in subjects diagnosed with acute ischemic stroke and undergoing a thrombectomy procedure within 8 hours of last known well.

Key Dates

Start date
Oct 1, 2021
Status verified
Aug 2025
Primary completion
May 28, 2024
Completion
May 28, 2024

Study Design

Enrollment
328 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Zoom Reperfusion System
    The subject will undergo the endovascular thrombectomy procedure under general anesthesia or conscious sedation. The Imperative Care .088" Catheter will be used to gain access to the vasculature and direct aspiration of the clot will be attempted where feasible. The Zoom Reperfusion System must be the initial and primary device used to remove thrombus.

Primary Outcome Measure

ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success [ Time Frame: Intraprocedural ]

Locations (28)

FacilityCityStateZIPSite coordinators
Radiology of HuntsvilleHuntsvilleAlabama35801-
Carondelet Neurological Institute St. Joseph's HospitalTucsonArizona85711-
University of Southern CaliforniaLos AngelesCalifornia90033-
John Muir HealthWalnut CreekCalifornia94598-
Baptist HealthJacksonvilleFlorida32207-
University of Miami / Jackson Memorial HospitalMiamiFlorida33136-
Tallahassee Neurological ClinicTallahasseeFlorida32308-
Tampa General Hospital / University of South FloridaTampaFlorida33606-
Grady Memorial Hospital / Emory UniversityAtlantaGeorgia30303-
Ochsner HealthNew OrleansLouisiana70121-
Spectrum HealthGrand RapidsMichigan49503-
Munson Medical CenterTraverse CityMichigan49684-
Cooper University Health CareCamdenNew Jersey08103-
The State University of New York at BuffaloBuffaloNew York14203-
Mount SinaiNew YorkNew York10029-
Montefiore Medical CenterThe BronxNew York10467-
The Ohio State University Medical CenterColumbusOhio43235-
Oklahoma UniversityOklahoma CityOklahoma73104-
Lehigh Valley HospitalAllentownPennsylvania18103-
University of PennsylvaniaPittsburghPennsylvania19104-
UPMCPittsburghPennsylvania15213-
Prisma Health - UpstateGreenvilleSouth Carolina29615-
Erlanger Health System: Tennessee Interventional and Imaging AssociatesChattanoogaTennessee37403-
Semmes Murphey Foundation / Methodist University HospitalMemphisTennessee38120-
Baylor Scott and White Research InstituteDallasTexas75204-
Valley Baptist Medical CenterHarlingenTexas78550-
The University of Texas Health Science Center at Houston // Memorial Hermann Health SystemHoustonTexas77007-
University of Texas Health Science Center at San AntonioSan AntonioTexas78229-

Find similar trials in Huntsville, AL

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Radiology of Huntsville· Huntsville, ALCarondelet Neurological Institute St. Joseph's Hospital· Tucson, AZUniversity of Southern California· Los Angeles, CAJohn Muir Health· Walnut Creek, CABaptist Health· Jacksonville, FLUniversity of Miami / Jackson Memorial Hospital· Miami, FL

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