SELECT2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke

Completed · Not applicable

Conditions studied: Acute Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT03876457

Run by

University Hospitals Cleveland Medical Center

People needed

352

Starts

2019-10-11

Expected to finish

2023-11-16

Last updated by the study team

2024-11-21

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults (18-85 years) with the final diagnosis of an acute ischemic stroke
• NIH Stroke Scale Score (NIHSS) ≥ 6
• Last known well to groin puncture or medical management between 0 to 24 hours
• Pre-stroke modified Rankin Scale score (mRS) of 0-1
• Eligible for thrombectomy 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
• Specific Neuroimaging Inclusion Criteria:
• Proven large vessel occlusion in ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial, with or without tandem MCA lesions) determined by MRA or CTA
• Large infarct-core lesion on at least one of the following:
• 2.1. Non-Contrast CT (ASPECTS of 3-5),
• 2.2. CT perfusion (rCBF<30% ≥50cc),
• 2.3. MRI-DWI (ADC<620 ≥50cc)

You may not qualify if…

• Inability to undergo CT angiography and/or CT perfusion imaging (e.g., renal insufficiency, iodine/contrast allergy)
• Co-morbid psychiatric or medical illnesses that would confound the neurological assessments
• Treatment with thrombolytic agent beyond 4.5 hours from last known well
• Treated with thrombolytic agent 3-4.5 hours after last known well AND any of the following:
• 1) age >80,
• 2) current anticoagulant use,
• 3) history of diabetes AND prior stroke,
• 4) NIHSS >25,
• 5) ischemic involvement of > 1/3 MCA territory
• Current participation in another investigational drug or device study.
• Neuroimaging Exclusion Criteria
• Patients who have both ASPECTS of 6-10 on non-contrast CT AND core volume <50 cc on perfusion imaging
• Patients with very large core on non-contrast CT i.e. ASPECTS ≤ 2
• Evidence of intracranial tumor (except small meningioma), acute intracranial hemorrhage, neoplasm, or arteriovenous malformation
• A 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

Where it is running

• Kaiser Permanente — Los Angeles, California, United States
• Baptist Health — Jacksonville, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Ascension St. Vincent Hospital — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Spectrum Health Hospital — Grand Rapids, Michigan, United States
• Westchester Medical Center — Valhalla, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Riverside Methodist Hospital - OhioHealth — Columbus, Ohio, United States
• Abington Jefferson Health — Abington, Pennsylvania, United States
• The Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• Semmes Murphey Clinic - University of Tennessee Health Science Center — Memphis, Tennessee, United States
• Dell Seton Medical Center at the University of Texas at Austin — Austin, Texas, United States
• Valley Baptist Medical Center — Harlingen, Texas, United States
• The University of Texas Health Science Center at Houston — Houston, Texas, United States
• Ascension Wisconsin — Milwaukee, Wisconsin, United States
• Liverpool Hospital - South Western Sydney Clinical School — Liverpool, New South Wales, Australia
• The Royal Adelaide Hospital (RAH) — Adelaide, South Australia, Australia
• Royal Melbourne Hospital — Melbourne, Victoria, Australia
• University of Alberta — Edmonton, Alberta, Canada
• University Health Network - Toronto Western Hospital — Toronto, Ontario, Canada
• Christchurch Hospital — Christchurch, Canterbury, New Zealand

Full record on ClinicalTrials.gov

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