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SELECT 2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke
Overall Recruitment Status: Active, currently enrolling
 
Official Title
SELECT 2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke
 
Region Sponsors
California - Southern
The University of Texas Health Science Center, Houston
 
Acronym KP IRB No.
12305
 
Study Type Phase
Clinical Trial n/a
 
Study Population Description
Individuals with confirmed diagnosis of an acute ischemic stroke.
 
Purpose
SELECT 2 evaluates the efficacy and safety of endovascular thrombectomy compared to medical management alone in acute ischemic stroke patients due to a large vessel occlusion in the distal ICA and MCA M1 who have large core on either CT (ASPECTS: 3-5) or advanced perfusion imaging ([rCBF=<30%] on CTP or [ADC=<620] on MRI:>=50cc) or both and are treated within 0-24 hours from last known well. The second aim is to look at the correlation of imaging profiles with thrombectomy clinical outcomes and treatment effect. This will be evaluated by comparing the outcomes in patients with discordant imaging profile and assessing if thrombectomy outcome rates and treatment effect will differ in patients with discordant imaging profiles (favorable CT/unfavorable perfusion imaging and unfavorable CT/favorable perfusion imaging).
 
Detailed Description
SELECT 2 is a prospective, randomized, international, multicenter, assessor-blinded controlled trial evaluating the efficacy and safety of thrombectomy in patients with large core on either CT or advanced perfusion imaging treated within 0-24 hours from last known well. The secondary aim is to look at the correlation of imaging profiles with thrombectomy clinical outcomes and treatment effect. Patients with the final diagnosis of an acute ischemic stroke due to a large vessel occlusion in the distal ICA and MCA M1 who have large core on either CT (ASPECTS: 3-5) or advanced perfusion imaging ([rCBF=<30%] on CTP or [ADC=<620] on MRI: >=50cc) or both within 0-24 hrs from last known well will be randomized in a 1:1 ratio into thrombectomy plus medical management vs medical management alone. Patient outcomes will be measured at baseline, 24 hours post, discharge, 30 days and 90 days.
 
Gender Age Limit
Male & Female 18 - 85 years
 
Inclusion Criteria
  • Adults (18-85 years) with the final diagnosis of an acute ischemic stroke
  • CT-angiogram or MR-angiogram proven large artery occlusion in the distal ICA or MCA M1 locations
  • NIHSS = > 6
  • Last known well to groin puncture or medical management between 0 to 24 hours
  • Baseline modified Rankin Scale score of 0-1
  • Eligible for thrombectomy with stent retriever or medical management
  • Signed Informed Consent obtained
  • Subject willing to comply with the protocol follow-up requirements
  • Anticipated life expectancy of at least 3 months
  • IV-tPA eligible patients treated per FDA guidelines
  • Please contact study team for more eligibility criteria
 
Exclusion Criteria
  • Inability to undergo CT-Angiography and/or CT/MR Perfusion imaging (e.g., renal insufficiency, iodine/contrast allergy)
  • Co-morbid psychiatric or medical illnesses that would confound the neurological assessments
  • Neuroimaging Exclusion Criteria: Patients who have both favorable CT and favorable CTP/MRP
  • Patients with very large core on imaging on non contrast CT i.e. ASPECTS =< 2
  • Evidence of intracranial tumor (except small meningioma) acute intracranial hemorrhage, neoplasm, or arteriovenous malformation
  • Significant mass effect with midline shift
  • Evidence of internal carotid artery dissection that is flow limiting or aortic dissection
  • Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device
  • Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion)
  • Signs of established infarct and large area of cerebral edema on non-contrast CT

 
Keywords and/or Specific Medical Conditions
  • Brain Diseases
  • Ischemia
  • Brain Infarction
  • Nervous System Diseases
  • Brain Ischemia
  • Pathologic Processes
  • Cardiovascular Diseases
  • Radiology
  • Central Nervous System Diseases
  • Stroke
  • Cerebral Infarction
  • Vascular Diseases
  • Cerebrovascular Disorders
  • Neurology (Neurological Disorders)
 
KP Clinical Facility
  • Southern California
 
Clinical Area
  • Neurology (Neurological Disorders)
  • Radiology


Principal Investigator:
Navdeep Sangha, MD
Contact Information:
- Tiffany Castanon
-626-564-5667
-Southern California


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