StrokeNet Thrombectomy Endovascular Platform

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Medical University of South Carolina
Study ID
NCT06289985
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Endovascular thrombectomy with any FDA-approved category POL or NRY device — DEVICE
    Endovascular thrombectomy with any FDA-approved category POL or NRY device - Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment (POL), and/or Catheter, Thrombus Retriever (NRY)
  • Medical Management — OTHER
    Medical Management (MM) may involve any combination of the following: intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol-lowering medications, and rehabilitative care.

Study Details

STEP is a Randomized, Multifactorial, Adaptive Platform trial that seeks to optimize the care of patients with acute ischemic stroke (AIS) due to large (LVO) or medium vessel occlusions (MVO).

Key Dates

Start date
Jan 31, 2025
Status verified
Dec 2025
Primary completion
Jan 31, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
1,600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Other: Endovascular Therapy (EVT) Indication Expansion Domain: Low NIHSS Strata
    Adult patients with acute cerebral ischemia within 24 hours of last known well who have large vessel occlusion (LVO) and mild deficits/low NIHSS (NIHSS 0-5) will be randomized to receive one of two strategies: * Endovascular Therapy (EVT) * Medical Management (MM)
  • Other: Endovascular Therapy (EVT) Indication Expansion Domain: Medium/Distal Occlusions Strata
    Adult patients with acute cerebral ischemia within 24 hours of last known who have Medium Vessel Occlusion (MVO) with Non-dominant/Co-dominant M2 occlusion or Distal Medium Vessel Occlusion (DMVO) patients with M3 occlusion will be randomized to receive one of two strategies: * Endovascular Therapy (EVT) * Medical Management (MM)

Primary Outcome Measure

Global disability measured by Modified Rankin Score [ Time Frame: 90-day ]

Central Contacts

Locations (41)

FacilityCityStateZIPSite coordinators
University of Alabama HospitalBirminghamAlabama35294-
UCSD Health La JollaLa JollaCalifornia92093-
Kaiser Permanente Los Angeles Medical CenterLos AngelesCalifornia90027-
Ronald Reagan UCLA Medical CenterLos AngelesCalifornia90095-
UCSD Medical Center - Hillcrest HospitalSan DiegoCalifornia92103-
Stanford University Medical CenterStanfordCalifornia94304-
Hartford HospitalHartfordConnecticut06106-
Yale New Haven HospitalNew HavenConnecticut06511-
Jackson Memorial HospitalMiamiFlorida33136-
Tampa General HospitalTampaFlorida33606-
Grady Memorial HospitalAtlantaGeorgia30303-
University of Chicago Medical CenterChicagoIllinois60637-
University of Iowa Hospitals & ClinicsIowa CityIowa52242-
Boston Medical CenterBostonMassachusetts02118-
Brigham and Women's HospitalBostonMassachusetts02115-
M Health Fairview Southdale HospitalEdinaMinnesota55435-
M Health Fairview University of Minnesota Medical CenterMinneapolisMinnesota55455-
Barnes Jewish HospitalSt LouisMissouri63110-
Cooper University HospitalCamdenNew Jersey08103-
NYU Langone HospitalBrooklynNew York11220-
Buffalo General Medical CenterBuffaloNew York14203-
The Mount Sinai HospitalNew YorkNew York10029-
Stony Brook University HospitalStony BrookNew York11794-
Montefiore Medical CenterThe BronxNew York10467-
Carolinas Medical CenterCharlotteNorth Carolina28207-
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157-
University of Cincinnati Medical CenterCincinnatiOhio45267-
Cleveland ClinicClevelandOhio44195-
UH Cleveland Medical CenterClevelandOhio44106-
OSU Wexner Medical CenterColumbusOhio43210-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
UPMC Mercy HospitalPittsburghPennsylvania15243-
UPMC Presbyterian HospitalPittsburghPennsylvania15213-
Rhode Island HospitalProvidenceRhode Island02903-
Medical University of South Carolina University HospitalCharlestonSouth Carolina29425-
Memorial Hermann Texas Medical CenterHoustonTexas77030-
Medical City PlanoPlanoTexas75075-
University of Texas Health Science CenterSan AntonioTexas78229-
University of Utah HealthcareSalt Lake CityUtah84132-
UVA Medical CenterCharlottesvilleVirginia22903-
Harborview Medical CenterSeattleWashington98104-

Find similar trials in Birmingham, AL

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
University of Alabama Hospital· Birmingham, ALUCSD Health La Jolla· La Jolla, CAKaiser Permanente Los Angeles Medical Center· Los Angeles, CARonald Reagan UCLA Medical Center· Los Angeles, CAUCSD Medical Center - Hillcrest Hospital· San Diego, CAStanford University Medical Center· Stanford, CA

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