StrokeNet Thrombectomy Endovascular Platform

Ischemic Stroke Clinical Trial

— STEP  

Official title:

STEP: StrokeNet Thrombectomy Endovascular Platform

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06289985
• Other study ID #: STEP
• Secondary ID: 1OT2NS129366-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: September 2028

Study information

• Verified date: March 2024
• Source: Medical University of South Carolina
• Contact: Harriet Howlett-Smith, RN, CCRC
• Phone: 470-545-1190
• Email: Howletha[@]ucmail.uc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

The StrokeNet Thrombectomy Endovascular Platform (STEP) is conducted within NIH StrokeNet at 38 comprehensive stroke centers across the US. The primary goal is to optimize all aspects of care of acute ischemic stroke patients with a large or a medium vessel occlusion. The platform trial operates under an overarching Master Protocol in an inferentially integrated framework. The platform trial is designed to support the studies of three broad categories of therapeutics: expansion of endovascular treatment (EVT) indications, innovative EVT devices and concomitant medical therapies, and novel pre- and early-hospital technologies and systems of care. As new interventions are put forth, they will be added to the Master Protocol as a new Domain or part of an existing Domain. STEP utilizes a flexible Bayesian design with frequent adaptive analyses to assess whether a given intervention is superior, inferior, or equivalent either within a Domain or for specific populations within the Domain.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: September 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

STEP PLATFORM INCLUSION CRITERIA:

1. Suspected diagnosis acute ischemic stroke

2. Likely causative intracranial large or medium vessel occlusion

STEP PLATFORM EXCLUSION CRITERIA:

1. Proven contraindication to endovascular thrombectomy

2. Prisoners/incarcerated DOMAIN-SPECIFIC ELIGIBILITY CRITERIA: Each domain may have additional eligibility criteria.

STEP EVT INDICATION EXPANSION DOMAIN INCLUSION CRITERIA:

1. Age 18 years or older

2. Pre-stroke modified Rankin Scale score 0-2

3. Within 24 hours of last known well

4. Has one of the following presentations:

a. Low NIHSS Patient (must have both): i.) Mild presenting neurologic deficits - NIHSS 0-5 ii.) Occlusion of the intracranial Internal Carotid Artery (ICA) or M1 Middle Cerebral Artery (MCA) b. Medium/Distal Vessel Occlusion (must have all 3): i.) Lumen diameter >/= 0.75 ii.) Non-dominant/Co-dominant M2 or M3,4 or A1,2,3 or P1,2,3 iii.) Less than 50% core in the territory supplied by the occluded vessel as evident by hypodensity and loss of grey-white border on Non-contrast Computed Tomography (NCCT) or ADC <620 mm2/s on diffusion MRI or rCBF<30% on Computed Tomography Perfusion (CTP) after 6h of symptom onset.

STEP EVT INDICATION EXPANSION DOMAIN EXCLUSION CRITERIA:

1. Clinical

1. Presumed septic embolus; suspicion of bacterial endocarditis

2. Seizure at stroke onset or between onset and enrollment

3. Allergy to contrast material that precludes endovascular reperfusion therapy

4. Intracranial occlusion suspected to be chronic, based on history and/or imaging

5. Intracranial dissection, based on history and/or imaging

6. Cerebral vasculitis, based on history and/or imaging

7. Known pregnancy

8. Known pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations

9. Known serious, advanced, or terminal illness or life expectancy less than 6 months in the investigator judgment

2. Laboratory a. Known platelet count <100.000 uL

3. Imaging

1. Unfavorable vascular anatomy that limits access to the occluded artery precluding endovascular reperfusion therapy.

2. Acute occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation)

3. Significant mass effect with midline shift (>5mm)

4. Evidence of intraaxial tumor (except small meningioma)

5. Evidence of acute intracranial hemorrhage

Related Conditions & MeSH terms

• Ischemic Stroke

Intervention

Device:
• Endovascular thrombectomy with any FDA-approved category POL or NRY 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)

Other:
• Medical Management
Medical Management (MM) may involve any combination of the following: intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol-lowering medications, and rehabilitative care.

Locations

Country	Name	City	State
n/a

Sponsors (11)

Lead Sponsor	Collaborator
Medical University of South Carolina	Berry Consultants, MOUNT SINAI HOSPITAL, National Institute of Neurological Disorders and Stroke (NINDS), Stony Brook University, The Cooper Health System, University at Buffalo, University of California, Los Angeles, University of Cincinnati, University of Pittsburgh Medical Center, University of Virginia

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Global disability measured by Modified Rankin Score	The modified Rankin Score is a 7-outcome ordinal scale where 0 = No symptoms and 6= Dead.	1 day of hospital discharge
Other	Neurological deficit as measured by the National Institutes of Health Stroke Scale (NIHSS)	NIHSS is a stroke severity score that ranges from 0 to 42, with higher numbers indicating a more severe stroke.	24 (+/-12) hours after the time of randomization
Other	Symptomatic intracranial hemorrhage	modified Heidelberg definition	36 hours after randomization
Other	Any radiologic intracranial hemorrhage	any acute intracranial blood, symptomatic or asymptomatic	36 hours after randomization
Other	Mortality	all cause deaths	90 days
Primary	Global disability measured by Modified Rankin Score	The modified Rankin Score is a 7-outcome ordinal scale where 0 = No symptoms and 6= Dead.; The analysis of the primary endpoint will be based on a utility weighting of the 7 outcomes, where 0 represents the worst possible health state and 1 represents the best possible state.	90-day