N/A N=352 Randomized Single-blind Treatment

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

Acute Ischemic Stroke

Bottom Line

View on ClinicalTrials.gov: NCT03876457 ↗

Enrolled (actual)

352

Serious AEs

71.6%

Results posted

Mar 2024

Primary outcome: Primary: Degree of Disability/Dependence as Measured by the Modified Rankin Scale (mRS) Score — 4; 5 scores on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Endovascular Thrombectomy (Device); Medical Management (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University Hospitals Cleveland Medical Center
Primary completion: Nov 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Degree of Disability/Dependence as Measured by the Modified Rankin Scale (mRS) Score	4; 5	—
SECONDARY Number of Participants That Achieved Functional Independence as Measured by a mRS Score of 0-2 at 90-day Follow-up	36; 12	—
SECONDARY Number of Participants That Achieved Independent Ambulation as Measured by a mRS Score of 0-3 at 90-day Follow-up	67; 32	—
SECONDARY Number of Patients That Suffered a Symptomatic Intracranial Hemorrhage (sICH) as Measured by the SITS-MOST Criteria	1; 2	—
SECONDARY Number of Participants With Neurological Worsening Defined as a ≥4-point Increase on the NIHSS Score Due to the Stroke Itself	44; 27	—
SECONDARY Number of Mortalities Within 90-day Follow-up	68; 71	—
SECONDARY Number of Procedural Complications	30	—
SECONDARY Successful Reperfusion in the EVT Group, Defined as Modified Thrombolysis in Cerebral Ischemia (mTICI) Grade of 2b or Higher	142	—
SECONDARY Discharge Location	19; 10; 11; 16; 72; 65	—
SECONDARY Number of Participants That Showed Early Neurological Improvement, Defined as Improvement of ≥8 Points on NIHSS at 24 Hours of Presentation or an NIHSS of 0-1	20; 13	—
SECONDARY Quality of Life Score, as Measured Using NeuroQOL at 90-day Follow-up	35.2; 25.1; 47.9; 53.6; 37.1; 33.5	—
SECONDARY The 1-year Functional Outcome, as Measured by the Modified Rankin Scale Score	5; 6	—
SECONDARY Number of Participants With Functional Independence, Defined as mRS Score of 0-2 at 1-year Follow-up	40; 9	—
SECONDARY Number of Participants With Independent Ambulation, Defined as mRS Score of 0-3 at 1-year Follow-up	63; 29	—
SECONDARY Quality of Life Score, as Measured Using NeuroQOL at 1 Year Follow-up	40.8; 27.2; 45.3; 52.1; 40.6; 35	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03876457). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.