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Endovascular Device
Endovascular Thrombectomy for Ischemic Stroke (SELECT2 Trial)
N/A
Waitlist Available
Led By Amrou Sarraj, MD
Research Sponsored by University Hospitals Cleveland Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
SELECT2 Trial Summary
This trial is looking at whether endovascular thrombectomy (a treatment to remove clots) is better than medical management alone for people who have had a stroke due to a large vessel occlusion in the distal ICA or MCA and who have a large core on either a CT scan or advanced perfusion imaging.
Who is the study for?
This trial is for adults aged 18-85 with acute ischemic stroke from a blocked artery in the brain, treated within 24 hours of symptom onset. Participants must have had good health before the stroke (mRS score of 0-1), a significant area of affected brain tissue, and be able to follow the study plan. Those with severe strokes, certain medical conditions or treatments that conflict with the study are excluded.Check my eligibility
What is being tested?
SELECT2 compares two approaches for treating acute ischemic stroke: endovascular thrombectomy (a procedure to remove blood clots) versus standard medical care alone. The focus is on patients who have large areas of damaged brain tissue but are still within a time window where treatment could help.See study design
What are the potential side effects?
Endovascular thrombectomy can cause bleeding in the brain, new blockages or damage to blood vessels during clot removal, reactions to contrast dye used in imaging, and potential complications from anesthesia. Standard medical management risks depend on specific medications used.
SELECT2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Degree of Disability/Dependence as Measured by the Modified Rankin Scale (mRS) Score
Secondary outcome measures
Discharge Location
Functional Independence, Defined as mRS Score of 0-2 at 1-year Follow-up
Independent Ambulation, Defined as mRS Score of 0-3 at 1-year Follow-up
+11 moreOther outcome measures
Infarct Volume on MRI DWI Sequence (or CT if MRI Not Feasible) 24 Hours to 7 Days After Randomization
Length of Hospital Stay
Lesion Growth Between the Ischemic Core on Baseline Imaging and the Follow-up Infarct Volume
+3 moreSide effects data
From 2019 Phase 4 trial • 151 Patients • NCT0174921553%
Loss of appetite
42%
Diarrhea
40%
Change in sense of taste
36%
Confusion
36%
Itching
32%
Abnormal vision
31%
Numbness or tingling
26%
Sleepiness
24%
Dizziness
24%
Slow thinking
24%
Fatigue
22%
Eye pain
13%
Depression
11%
Difficulty with memory
10%
Nervousness
10%
Language problems (e.g., word searching)
10%
Difficulty with concentration or attention
8%
Suicidal thoughts or actions
1%
Inpatient hospitalization for lower quadrant pain, cough and chills
1%
Inpatient hospitalization for pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Topiramate
Placebo
SELECT2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Endovascular Thrombectomy plus Medical ManagementExperimental Treatment2 Interventions
Group II: Medical ManagementActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Endovascular Thrombectomy
2019
Completed Phase 2
~640
Find a Location
Who is running the clinical trial?
University Hospitals Cleveland Medical CenterLead Sponsor
318 Previous Clinical Trials
339,733 Total Patients Enrolled
1 Trials studying Stroke
7 Patients Enrolled for Stroke
Stryker NeurovascularIndustry Sponsor
35 Previous Clinical Trials
12,387 Total Patients Enrolled
10 Trials studying Stroke
3,730 Patients Enrolled for Stroke
The University of Texas Health Science Center, HoustonOTHER
904 Previous Clinical Trials
320,608 Total Patients Enrolled
42 Trials studying Stroke
7,055 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a very large area of damage in your brain on a certain type of CT scan.You have a large brain mass causing a shift in the middle of the brain.You are unable to have CT scans with contrast dye due to kidney problems or allergies to the dye.You have other mental or physical health conditions that could make it harder to understand the brain tests.You had a medication to dissolve blood clots more than 4.5 hours after showing symptoms of a stroke.You received a clot-dissolving medication 3-4.5 hours after your last known well time and have one or more of the following: 1) you are over 80 years old, 2) taking a blood-thinning medication, 3) have diabetes and a prior stroke, 4) have a high NIH Stroke Scale score, or 5) have a large portion of your brain affected by the stroke.You have a specific score on your brain scan and a certain size of damaged brain tissue.You have a tumor in your brain, recent bleeding in your brain, or a blood vessel problem in your brain.You have a stent in your brain that would make it unsafe to use the neurothrombectomy device.The time between when you were last known to be well and when you received medical treatment is between 0 and 24 hours.You had little to no disability before the stroke, based on a specific scale.You can have a procedure to remove a blood clot or receive medical treatment.You are expected to live for at least 3 months.You have a blockage in a major blood vessel in the brain, which has been confirmed by a special type of imaging test.You have a condition where the main blood vessels in your neck or chest are damaged.You have blockages in more than one important blood vessel confirmed by special imaging tests.You have signs of a previous stroke and a large area of swelling in the brain on a specific type of CT scan.You have a large area of damaged brain tissue from a stroke, as shown on imaging tests.Adults aged 18 to 85 who have been diagnosed with a recent ischemic stroke.You have a NIH Stroke Scale Score (NIHSS) of 6 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Medical Management
- Group 2: Endovascular Thrombectomy plus Medical Management
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitment efforts still being made for this clinical trial?
"Indeed, the clinicaltrial.gov database states that this trial is actively recruiting for 560 individuals from 19 different healthcare facilities. The initial posting date was October 11th 2019 with a most recent update of April 25th 2022."
Answered by AI
Are there any Canadian locations hosting this scientific research?
"University of Kansas Medical Center in Kansas City, The Hospital of the University of Pennsylvania in Philadelphia, and Baptist Health in Jacksonville are three sites partaking in this trial. Additionally, 19 other medical centres are recruiting patients for it."
Answered by AI
Am I a suitable candidate to join this research project?
"This trial is enrolling 560 stroke patients between 18 and 85 years old. In order to qualify, they must have an NIH Stroke Scale Score (NIHSS) of 6 or higher, verified large vessel occlusion in ICA/MCA-M1 determined by MRA/CTA scans, expected life expectancy of at least 3 months, pre-stroke modified Rankin Scale score mRS 0-1, willingness to follow the protocol's requirements for follow up care and be eligible for thrombectomy or medical management. Furthermore a non contrast CT scan with ASPECTS rating 3-5 must also be provided."
Answered by AI
What is the sample size for this clinical trial?
"The study requires 560 individuals that meet the eligibility standards to partake in this clinical trial. People from Kansas City, Kansas and Philadelphia, Pennsylvania can take part at University of Kansas Medical Center or The Hospital of the University of Pennsylvania respectively."
Answered by AI
Is this research endeavor actively seeking elderly individuals?
"Candidates from 18 to 85 years old can enrol in this medical trial."
Answered by AI
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