Acute Ischemic StrokeSELECT2NCT03876457
SELECT2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke
A study testing Endovascular Thrombectomy and Medical Management in people with Acute Ischemic Stroke, run by University Hospitals Cleveland Medical Center at 31 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Endovascular Thrombectomy and Medical Management
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 31 sitesin 6 countries
- Study dates
- 11 Oct 2019to 16 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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,
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- 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
Trial locations and contacts
31 sites in 6 countries.
31 sites in 6 countries
United States19 sites
Abington Jefferson Health
Abington, Pennsylvania, 19001
Dell Seton Medical Center at the University of Texas at Austin
Austin, Texas, 78712
Rush University Medical Center
Chicago, Illinois, 60612
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Riverside Methodist Hospital - OhioHealth
Columbus, Ohio, 43214
Spectrum Health Hospital
Grand Rapids, Michigan, 49503
Valley Baptist Medical Center
Harlingen, Texas, 78550
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Ascension St. Vincent Hospital
Indianapolis, Indiana, 46260
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Baptist Health
Jacksonville, Florida, 32207
University of Kansas Medical Center
Kansas City, Kansas, 66160
Kaiser Permanente
Los Angeles, California, 90027
Semmes Murphey Clinic - University of Tennessee Health Science Center
Memphis, Tennessee, 38163
Ascension Wisconsin
Milwaukee, Wisconsin, 53215
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Westchester Medical Center
Valhalla, New York, 10595
Spain5 sites
Hospital Universitario Germans Trias i Pujol
Badalona
Hospital Clínic i Provincial de Barcelona
Barcelona
Hospital Universitari de Bellvitge
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Hospital Clínico Universitario de Valladolid
Valladolid
Australia3 sites
The Royal Adelaide Hospital (RAH)
Adelaide, South Australia
Liverpool Hospital - South Western Sydney Clinical School
Liverpool, New South Wales
Royal Melbourne Hospital
Melbourne, Victoria
Canada2 sites
University of Alberta
Edmonton, Alberta, T6G 2B7
University Health Network - Toronto Western Hospital
Toronto, Ontario
About this study
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.
Read the detailed description
SELECT 2 is a prospective, phase III 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.
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.
The primary endpoint is the Modified Rankin Scale (mRS) at 90 (+/- 15) days. The primary outcome is a shift on 90-day mRS. Secondary outcomes are favorable clinical outcomes: mRS score of 0-2, safety outcomes such the incidence of symptomatic intracranial hemorrhage (sICH per SITS-MOST) and Imaging endpoints such as infarct volume on MRI diffusion-weighted imaging (DWI) sequence (or CT if MRI not feasible) 24 to 72 hours after randomization. CT images will be read by iSchemaView automated ASPECTS as well as by a physician. In cases where there is disagreement, the physician reading will override the automated software reading. CT/MR perfusion images with mismatch determination will be read by iSchemaView automated RAPID software. All the images will be adjudicated by a blinded core lab at the University of Texas-Medical School at Houston.
A maximum of 560 patients will be randomized across the study sites. Covariate adaptive randomization will be used to balance the distribution of important variables. Interim analyses will be conducted at 200 and 380 patients, at which time the study may stop for efficacy or futility.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Endovascular Thrombectomy, Medical Management
- Keywords
- Ischemic stroke, Large vessel occlusion, Endovascular thrombectomy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular ThrombectomyDevice
Patients randomized to endovascular thrombectomy arm will receive thrombectomy plus medical management. They will be treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices which will be used are FDA-approved stent retrievers: the Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with or without aspiration, will be left up to the interventionalist, with any of the FDA-approved devices approved in the study protocol or a combination of them.
Medical ManagementOther
Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Thrombectomy plus Medical Management | Experimental | Not described Receives: Device: Endovascular Thrombectomy; Other: Medical Management |
| Medical Management | Active comparator | Not described Receives: Other: Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Disability/Dependence as Measured by the Modified Rankin Scale (mRS) Score
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.
Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.
Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
Score 6: Dead
Measured: 90 days
Secondary outcomes (14)
Number of Participants That Achieved Functional Independence as Measured by a mRS Score of 0-2 at 90-day Follow-up
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.
Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.
Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
Score 6: Dead
Measured: 90 days
Number of Participants That Achieved Independent Ambulation as Measured by a mRS Score of 0-3 at 90-day Follow-up
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.
Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.
Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
Score 6: Dead
Measured: 90 days
Number of Patients That Suffered a Symptomatic Intracranial Hemorrhage (sICH) as Measured by the SITS-MOST Criteria
Measured: 24 hours
Number of Participants With Neurological Worsening Defined as a ≥4-point Increase on the NIHSS Score Due to the Stroke Itself
Measured: 24 hours
Number of Mortalities Within 90-day Follow-up
Measured: 90 days
Number of Procedural Complications
The following were included in the complications counted:
- Surgical site hematoma
- Surgical site infection
- Vascular injury (peripheral or intracranial dissection, perforation or others) caused by the endovascular procedure
Measured: 24 hours
Successful Reperfusion in the EVT Group, Defined as Modified Thrombolysis in Cerebral Ischemia (mTICI) Grade of 2b or Higher
Measured: at the end of endovascular thrombectomy procedure
Discharge Location
Measured: day 5-7 after randomization/at discharge (whichever is later)
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
Measured: 24 hours
Quality of Life Score, as Measured Using NeuroQOL at 90-day Follow-up
The Neurological Quality of Life score (NeuroQoL) is a patient-reported outcome measure that assesses the impact of neurological disorders on various aspects of a person's quality of life in neurological diseases and has measures developed across 17 different domains. The trial measured NeuroQoL scores for Mobility, Depression, Social and Cognitive domains. The scores provide a measure of an individual's quality of life in a given domain relative to a reference population, with a mean score of 50 and range of 0-100. A t-score of 50 indicates average quality of life, while scores above 50 indicate better-than-average quality of life and scores below 50 indicate poorer-than-average quality of life, except for depression domain - where lower scores indicate better and higher scores indicate worse quality of life.
Measured: 90 days
The 1-year Functional Outcome, as Measured by the Modified Rankin Scale Score
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.
Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.
Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
Score 6: Dead
Measured: 1 year
Number of Participants With Functional Independence, Defined as mRS Score of 0-2 at 1-year Follow-up
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms. Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Score 6: Dead
Measured: 1 year
Number of Participants With Independent Ambulation, Defined as mRS Score of 0-3 at 1-year Follow-up
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms. Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Score 6: Dead
Measured: 1 year
Quality of Life Score, as Measured Using NeuroQOL at 1 Year Follow-up
Quality of Life scores in mobility, depression,social and cognitive domains
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start11 Oct 2019
- Primary completion20 Nov 2022
- Study completion16 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Neurovascular, The University of Texas Health Science Center, Houston
- Responsible party
- Principal investigator, Amrou Sarraj, University Hospitals Cleveland Medical Center
- Investigators
- Amrou Sarraj, MD, Principal investigator, Case Western Reserve University - University Hospitals Cleveland Medical Center(Australia and Oceania) Bruce CV Campbell, MBBS PhD, Principal investigator, Melbourne Health(Europe) Marc Ribo, MD, Principal investigator, Vall d'Hebron University Hospital, Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876457
- Sponsor's protocol ID
- G180275, Pro00056862
- Acronym
- SELECT2
- Status last verified
- Nov 2024
- First submitted
- 8 Mar 2019
- Last updated
- 21 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ng FC, Yogendrakumar V, Johns HT, Churilov L, Hassan AE, Abraham MG, Ortega-Gutierrez S, Hussain MS, Chen M, Sitton CW, Kasner SE, Sharma G, Guha P, Pujara D, Mendes Pereira V, Lansberg MG, Wechsler LR, Nguyen TN, Fifi JT, Hill MD, Ribo M, Parsons MW, Davis SM, Grotta JC, Albers GW, Campbell BCV, Sarraj A; SELECT2 Investigators. Cerebral Edema in Patients With Large Ischemic Core After Thrombectomy: A Secondary Analysis of SELECT2 Randomized Trial. Stroke. 2026 Jun;57(6):1492-1500. doi: 10.1161/STROKEAHA.125.054015. Epub 2026 Mar 30.
PubMed 41906875Sarraj A, Blackburn S, Abraham MG, Hussain MS, Ortega-Gutierrez S, Chen M, Kasner SE, Churilov L, Sitton CW, Pujara DK, Sundararajan S, Hu YC, Herial NA, Budzik RF, Hicks WJ, Vora N, Arenillas JF, Alfonso ML, Ramos Araque ME, Tsai JP, Abdulrazzak MA, Kozak O, Yan B, Mitchell PJ, Cordato DJ, Manning NW, Cheung A, Hanel RA, Aghaebrahim AN, Wu TY, Portela PC, Merchan AJP, Gandhi CD, Al-Mufti F, Samaniego EA, Maali L, Qureshi A, Lechtenberg CG, Slavin S, Rosterman L, Gibson D, Wallace AN, Sahlein D, Perez de la Ossa N, Hernandez Perez M, Schaafsma JD, Blasco J, Renu A, Sangha N, Warach S, Kleinig TJ, Mullen M, Elijovich L, Shaker F, Al-Shaibi FK, Johns H, Duncan KR, Opaskar A, Popovic MJ, Altose M, Ray A, Xiong W, Sunshine J, DeGeorgia M, Nguyen TN, Fifi JT, Tjoumakaris S, Jabbour P, Pereira VM, Lansberg MG, Albers GW, Sila C, Bambakidis N, Davis S, Wechsler L, Hill MD, Grotta JC, Ribo M, Hassan AE, Campbell BC; SELECT2 Investigators. General vs Nongeneral Anesthesia for Endovascular Thrombectomy in Patients With Large Core Strokes: A Prespecified Secondary Analysis of SELECT2 Trial. Neurology. 2025 Jul 22;105(2):e213819. doi: 10.1212/WNL.0000000000213819. Epub 2025 Jun 26.
PubMed 40570276Yogendrakumar V, Campbell BCV, Johns HT, Churilov L, Ng FC, Sitton CW, Hassan AE, Abraham MG, Ortega-Gutierrez S, Hussain MS, Chen M, Kasner SE, Sharma G, Guha P, Pujara DK, Shaker F, Lansberg MG, Wechsler LR, Nguyen TN, Fifi JT, Hill MD, Ribo M, Parsons MW, Davis SM, Grotta JC, Albers GW, Sarraj A; SELECT2 Investigators. Association of Ischemic Core Hypodensity With Thrombectomy Treatment Effect in Large Core Stroke: A Secondary Analysis of the SELECT2 Randomized Controlled Trial. Stroke. 2025 Jun;56(6):1366-1375. doi: 10.1161/STROKEAHA.124.048899. Epub 2025 Mar 28.
PubMed 40151939Ortega-Gutierrez S, Rodriguez-Calienes A, Pujara D, Sitton C, Galecio-Castillo M, Hassan AE, Abraham MG, Chen M, Blackburn S, Kasner SE, Olalde H, Ghannam M, Hussain MS, Leira EC, Martinez-Galdamez M, Shaban A, Tsai JP, Roeder H, Gudenkauf JC, Budzik R, Vora N, Hanel RA, Aghaebrahim A, Colgan F, de Miquel MA, Gandhi CD, Al-Mufti F, Blasco J, San Roman Manzanera L, Herial NA, Manning NW, Cheung A, Kozak O, Yan B, Mitchell PJ, Ebersole K, Toth G, Gooch M, Gibson D, Sahlein DH, Amuluru K, Abdulrazzak MA, Duncan K, Defta D, Shaker F, Al-Shaibi F, Ray A, Sunshine J, Hu YC, Burkhardt JK, Mir O, Alenzi B, Kass-Hout T, Gupta R, Tjoumakaris SI, Jabbour PM, Nguyen TN, Fifi JT, Pereira VM, Bambakidis N, Hill MD, Grotta JC, Ribo M, Campbell BCV, Samaniego EA, Sarraj A. Endovascular Thrombectomy for Extracranial Internal Carotid Artery Occlusions With Large Ischemic Strokes: Insights From the SELECT2 Trial. Neurology. 2025 Feb 25;104(4):e210269. doi: 10.1212/WNL.0000000000210269. Epub 2025 Jan 27.
PubMed 39869840Tsai JP, Nguyen TN, Pujara DK, Fifi JT, Sundararajan S, Schaafsma JD, Perez de la Ossa N, Abraham MG, Chen M, Hussain MS, Ortega-Gutierrez S, Johns HT, Duncan KR, Churilov L, Lechtenberg CG, Slavin SJ, Opaskar A, de Lera M, Lara-Rodriguez B, Quesada H, Fournier LE, Defta DM, Shaker F, Sitton CW, Sharrief AZ, Grotta JC, Hill MD, Ribo M, Hassan AE, Campbell BCV, Sila C, Tjoumakaris SI, Sarraj A; for SELECT2 Investigators. Sex-Based Differences in Endovascular Thrombectomy Outcomes for Large Ischemic Stroke: A SELECT2 Subanalysis. Stroke. 2025 Feb;56(2):294-304. doi: 10.1161/STROKEAHA.124.049307. Epub 2025 Jan 2.
PubMed 39744837Chen H, Malhotra A, Gandhi D. Thrombectomy for Large Strokes. N Engl J Med. 2024 Jul 25;391(4):378-379. doi: 10.1056/NEJMc2406965. No abstract available.
PubMed 39047249Pujara DK, Hussain MS, Abraham MG, Ortega-Gutierrez S, Chen M, Kasner SE, Churilov L, Sitton CW, Blackburn S, Sundararajan S, Hu YC, Herial NA, Budzik RF, Hicks WJ, Arenillas JF, Tsai JP, Kozak O, Cordato DJ, Manning NW, Hanel RA, Aghaebrahim AN, Wu TY, Cardona Portela P, Perez de la Ossa N, Schaafsma JD, Blasco J, Sangha N, Warach S, Gandhi CD, Al-Mufti F, Kleinig TJ, Al-Shaibi F, Duncan KR, Shaker F, Johns H, Xiong W, DeGeorgia M, Opaskar A, Sunshine J, Ray A, Jabbour P, Bambakidis N, Sila C, Nguyen TN, Grotta JC, Hassan AE, Ribo M, Hill MD, Campbell BC, Sarraj A; For SELECT2 Investigators. Anticoagulation Use and Endovascular Thrombectomy in Patients with Large Core Stroke: A Secondary Analysis of the SELECT2 Trial. Ann Neurol. 2024 Nov;96(5):887-894. doi: 10.1002/ana.27021. Epub 2024 Jul 22.
PubMed 39039739Sarraj A, Hill MD, Hussain MS, Abraham MG, Ortega-Gutierrez S, Chen M, Kasner SE, Churilov L, Pujara DK, Johns H, Blackburn S, Sundararajan S, Hu YC, Herial NA, Budzik RF, Hicks WJ, Arenillas JF, Tsai JP, Kozak O, Cordato DJ, Hanel RA, Wu TY, Portela PC, Gandhi CD, Al-Mufti F, Maali L, Gibson D, Perez de la Ossa N, Schaafsma JD, Blasco J, Sangha N, Warach S, Kleinig TJ, Shaker F, Sitton CW, Nguyen T, Fifi JT, Jabbour P, Furlan A, Lansberg MG, Tsivgoulis G, Sila C, Bambakidis N, Davis S, Wechsler L, Albers GW, Grotta JC, Ribo M, Campbell BC, Hassan AE; SELECT2 Investigators; SELECT2 Collaborators; Vora N, Manning NW, Cheung A, Aghaebrahim AN, Paipa Merchan AJ, Sahlein D, Requena Ruiz M, Elijovich L, Arthur A, Al-Shaibi F, Samaniego EA, Duncan KR, Opaskar A, Ray A, Xiong W, Sunshine J, DeGeorgia M, Tjoumakaris S, Mendes Pereira V; SELECT2 Collaborators. Endovascular Thrombectomy Treatment Effect in Direct vs Transferred Patients With Large Ischemic Strokes: A Prespecified Analysis of the SELECT2 Trial. JAMA Neurol. 2024 Feb 8;81(4):327-35. doi: 10.1001/jamaneurol.2024.0206. Online ahead of print.
PubMed 38363872Sarraj A, Abraham MG, Hassan AE, Blackburn S, Kasner SE, Ortega-Gutierrez S, Hussain MS, Chen M, Johns H, Churilov L, Pujara DK, Shaker F, Maali L, Cardona Portela P, Herial NA, Gibson D, Kozak O, Arenillas JF, Yan B, Perez de la Ossa N, Sundararajan S, Hu YC, Cordato DJ, Manning NW, Hanel RA, Aghaebrahim AN, Budzik RF, Hicks WJ, Blasco J, Wu TY, Tsai JP, Schaafsma JD, Gandhi CD, Al-Mufti F, Sangha N, Warach S, Kleinig TJ, Yogendrakumar V, Ng F, Samaniego EA, Abdulrazzak MA, Parsons MW, Rahbar MH, Nguyen TN, Fifi JT, Mendes Pereira V, Lansberg MG, Albers GW, Furlan AJ, Jabbour P, Sitton CW, Sila C, Bambakidis N, Davis SM, Wechsler L, Hill MD, Grotta JC, Ribo M, Campbell BCV; SELECT2 Investigators. Endovascular thrombectomy plus medical care versus medical care alone for large ischaemic stroke: 1-year outcomes of the SELECT2 trial. Lancet. 2024 Feb 24;403(10428):731-740. doi: 10.1016/S0140-6736(24)00050-3. Epub 2024 Feb 9.
PubMed 38346442Sarraj A, Hassan AE, Abraham MG, Ortega-Gutierrez S, Kasner SE, Hussain MS, Chen M, Churilov L, Johns H, Sitton CW, Yogendrakumar V, Ng FC, Pujara DK, Blackburn S, Sundararajan S, Hu YC, Herial NA, Arenillas JF, Tsai JP, Budzik RF, Hicks WJ, Kozak O, Yan B, Cordato DJ, Manning NW, Parsons MW, Cheung A, Hanel RA, Aghaebrahim AN, Wu TY, Portela PC, Gandhi CD, Al-Mufti F, Perez de la Ossa N, Schaafsma JD, Blasco J, Sangha N, Warach S, Kleinig TJ, Shaker F, Al Shaibi F, Toth G, Abdulrazzak MA, Sharma G, Ray A, Sunshine J, Opaskar A, Duncan KR, Xiong W, Samaniego EA, Maali L, Lechtenberg CG, Renu A, Vora N, Nguyen T, Fifi JT, Tjoumakaris SI, Jabbour P, Tsivgoulis G, Pereira VM, Lansberg MG, DeGeorgia M, Sila CA, Bambakidis N, Hill MD, Davis SM, Wechsler L, Grotta JC, Ribo M, Albers GW, Campbell BC; SELECT2 Investigators. Endovascular Thrombectomy for Large Ischemic Stroke Across Ischemic Injury and Penumbra Profiles. JAMA. 2024 Mar 5;331(9):750-763. doi: 10.1001/jama.2024.0572.
PubMed 38324414Sarraj A, Hassan AE, Abraham MG, Ortega-Gutierrez S, Kasner SE, Hussain MS, Chen M, Blackburn S, Sitton CW, Churilov L, Sundararajan S, Hu YC, Herial NA, Jabbour P, Gibson D, Wallace AN, Arenillas JF, Tsai JP, Budzik RF, Hicks WJ, Kozak O, Yan B, Cordato DJ, Manning NW, Parsons MW, Hanel RA, Aghaebrahim AN, Wu TY, Cardona-Portela P, Perez de la Ossa N, Schaafsma JD, Blasco J, Sangha N, Warach S, Gandhi CD, Kleinig TJ, Sahlein D, Elijovich L, Tekle W, Samaniego EA, Maali L, Abdulrazzak MA, Psychogios MN, Shuaib A, Pujara DK, Shaker F, Johns H, Sharma G, Yogendrakumar V, Ng FC, Rahbar MH, Cai C, Lavori P, Hamilton S, Nguyen T, Fifi JT, Davis S, Wechsler L, Pereira VM, Lansberg MG, Hill MD, Grotta JC, Ribo M, Campbell BC, Albers GW; SELECT2 Investigators. Trial of Endovascular Thrombectomy for Large Ischemic Strokes. N Engl J Med. 2023 Apr 6;388(14):1259-1271. doi: 10.1056/NEJMoa2214403. Epub 2023 Feb 10.
PubMed 36762865Sarraj A, Campbell BCV, Christensen S, Sitton CW, Khanpara S, Riascos RF, Pujara D, Shaker F, Sharma G, Lansberg MG, Albers GW; SELECT Investigators. Accuracy of CT Perfusion-Based Core Estimation of Follow-up Infarction: Effects of Time Since Last Known Well. Neurology. 2022 May 24;98(21):e2084-e2096. doi: 10.1212/WNL.0000000000200269. Epub 2022 Apr 21.
PubMed 35450966Sarraj A, Hassan AE, Abraham M, Ribo M, Blackburn S, Chen M, Hussain MS, Pereira VM, Ortega-Gutierrez S, Sitton C, Lavori PW, Cai C, Rahbar M, Pujara D, Shaker F, Lansberg MG, Campbell B, Grotta JC, Albers GW; SELECT2 Investigators. A randomized controlled trial to optimize patient's selection for endovascular treatment in acute ischemic stroke (SELECT2): Study protocol. Int J Stroke. 2022 Jul;17(6):689-693. doi: 10.1177/17474930211035032. Epub 2021 Dec 15.
PubMed 34282987
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SELECT2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03876457
- Acronym / sponsor ID
- SELECT2 / G180275, Pro00056862
- Conditions
- Acute Ischemic Stroke
- Keywords
- Ischemic stroke, Large vessel occlusion, Endovascular thrombectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Stryker Neurovascular, The University of Texas Health Science Center, Houston
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 16 Nov 2023 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Posted 15 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
SELECT 2 is a prospective, phase III 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.
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.
The primary endpoint is the Modified Rankin Scale (mRS) at 90 (+/- 15) days. The primary outcome is a shift on 90-day mRS. Secondary outcomes are favorable clinical outcomes: mRS score of 0-2, safety outcomes such the incidence of symptomatic intracranial hemorrhage (sICH per SITS-MOST) and Imaging endpoints such as infarct volume on MRI diffusion-weighted imaging (DWI) sequence (or CT if MRI not feasible) 24 to 72 hours after randomization. CT images will be read by iSchemaView automated ASPECTS as well as by a physician. In cases where there is disagreement, the physician reading will override the automated software reading. CT/MR perfusion images with mismatch determination will be read by iSchemaView automated RAPID software. All the images will be adjudicated by a blinded core lab at the University of Texas-Medical School at Houston.
A maximum of 560 patients will be randomized across the study sites. Covariate adaptive randomization will be used to balance the distribution of important variables. Interim analyses will be conducted at 200 and 380 patients, at which time the study may stop for efficacy or futility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular Thrombectomy plus Medical Management | Experimental | Device: Endovascular Thrombectomy, Other: Medical Management |
| Medical Management | Active comparator | Other: Medical Management |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (19 listed)
- 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:
- Current participation in another investigational drug or device study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular ThrombectomyPatients randomized to endovascular thrombectomy arm will receive thrombectomy plus medical management. They will be treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices which will be used are FDA-approved stent retrievers: the Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with or without aspiration, will be left up to the interventionalist, with any of the FDA-approved devices approved in the study protocol or a combination of them. | Device | Endovascular Thrombectomy plus Medical Management |
| Medical ManagementPatients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients. | Other | Endovascular Thrombectomy plus Medical Management, Medical Management |
Primary outcome
Degree of Disability/Dependence as Measured by the Modified Rankin Scale (mRS) Score
Time frame: 90 days
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms. Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Score 6: Dead
14 secondary outcomes
Number of Participants That Achieved Functional Independence as Measured by a mRS Score of 0-2 at 90-day Follow-up
Time frame: 90 days
Number of Participants That Achieved Independent Ambulation as Measured by a mRS Score of 0-3 at 90-day Follow-up
Time frame: 90 days
Number of Patients That Suffered a Symptomatic Intracranial Hemorrhage (sICH) as Measured by the SITS-MOST Criteria
Time frame: 24 hours
Number of Participants With Neurological Worsening Defined as a ≥4-point Increase on the NIHSS Score Due to the Stroke Itself
Time frame: 24 hours
Number of Mortalities Within 90-day Follow-up
Time frame: 90 days
Number of Procedural Complications
Time frame: 24 hours
Successful Reperfusion in the EVT Group, Defined as Modified Thrombolysis in Cerebral Ischemia (mTICI) Grade of 2b or Higher
Time frame: at the end of endovascular thrombectomy procedure
Discharge Location
Time frame: day 5-7 after randomization/at discharge (whichever is later)
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
Time frame: 24 hours
Quality of Life Score, as Measured Using NeuroQOL at 90-day Follow-up
Time frame: 90 days
The 1-year Functional Outcome, as Measured by the Modified Rankin Scale Score
Time frame: 1 year
Number of Participants With Functional Independence, Defined as mRS Score of 0-2 at 1-year Follow-up
Time frame: 1 year
Number of Participants With Independent Ambulation, Defined as mRS Score of 0-3 at 1-year Follow-up
Time frame: 1 year
Quality of Life Score, as Measured Using NeuroQOL at 1 Year Follow-up
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41906875Ng FC, Yogendrakumar V, Johns HT, Churilov L, Hassan AE, Abraham MG, Ortega-Gutierrez S, Hussain MS, Chen M, Sitton CW, Kasner SE, Sharma G, Guha P, Pujara D, Mendes Pereira V, Lansberg MG, Wechsler LR, Nguyen TN, Fifi JT, Hill MD, Ribo M, Parsons MW, Davis SM, Grotta JC, Albers GW, Campbell BCV, Sarraj A; SELECT2 Investigators. Cerebral Edema in Patients With Large Ischemic Core After Thrombectomy: A Secondary Analysis of SELECT2 Randomized Trial. Stroke. 2026 Jun;57(6):1492-1500. doi: 10.1161/STROKEAHA.125.054015. Epub 2026 Mar 30.
- Derived from this study: PubMed 40570276Sarraj A, Blackburn S, Abraham MG, Hussain MS, Ortega-Gutierrez S, Chen M, Kasner SE, Churilov L, Sitton CW, Pujara DK, Sundararajan S, Hu YC, Herial NA, Budzik RF, Hicks WJ, Vora N, Arenillas JF, Alfonso ML, Ramos Araque ME, Tsai JP, Abdulrazzak MA, Kozak O, Yan B, Mitchell PJ, Cordato DJ, Manning NW, Cheung A, Hanel RA, Aghaebrahim AN, Wu TY, Portela PC, Merchan AJP, Gandhi CD, Al-Mufti F, Samaniego EA, Maali L, Qureshi A, Lechtenberg CG, Slavin S, Rosterman L, Gibson D, Wallace AN, Sahlein D, Perez de la Ossa N, Hernandez Perez M, Schaafsma JD, Blasco J, Renu A, Sangha N, Warach S, Kleinig TJ, Mullen M, Elijovich L, Shaker F, Al-Shaibi FK, Johns H, Duncan KR, Opaskar A, Popovic MJ, Altose M, Ray A, Xiong W, Sunshine J, DeGeorgia M, Nguyen TN, Fifi JT, Tjoumakaris S, Jabbour P, Pereira VM, Lansberg MG, Albers GW, Sila C, Bambakidis N, Davis S, Wechsler L, Hill MD, Grotta JC, Ribo M, Hassan AE, Campbell BC; SELECT2 Investigators. General vs Nongeneral Anesthesia for Endovascular Thrombectomy in Patients With Large Core Strokes: A Prespecified Secondary Analysis of SELECT2 Trial. Neurology. 2025 Jul 22;105(2):e213819. doi: 10.1212/WNL.0000000000213819. Epub 2025 Jun 26.
- Derived from this study: PubMed 40151939Yogendrakumar V, Campbell BCV, Johns HT, Churilov L, Ng FC, Sitton CW, Hassan AE, Abraham MG, Ortega-Gutierrez S, Hussain MS, Chen M, Kasner SE, Sharma G, Guha P, Pujara DK, Shaker F, Lansberg MG, Wechsler LR, Nguyen TN, Fifi JT, Hill MD, Ribo M, Parsons MW, Davis SM, Grotta JC, Albers GW, Sarraj A; SELECT2 Investigators. Association of Ischemic Core Hypodensity With Thrombectomy Treatment Effect in Large Core Stroke: A Secondary Analysis of the SELECT2 Randomized Controlled Trial. Stroke. 2025 Jun;56(6):1366-1375. doi: 10.1161/STROKEAHA.124.048899. Epub 2025 Mar 28.
- Derived from this study: PubMed 39869840Ortega-Gutierrez S, Rodriguez-Calienes A, Pujara D, Sitton C, Galecio-Castillo M, Hassan AE, Abraham MG, Chen M, Blackburn S, Kasner SE, Olalde H, Ghannam M, Hussain MS, Leira EC, Martinez-Galdamez M, Shaban A, Tsai JP, Roeder H, Gudenkauf JC, Budzik R, Vora N, Hanel RA, Aghaebrahim A, Colgan F, de Miquel MA, Gandhi CD, Al-Mufti F, Blasco J, San Roman Manzanera L, Herial NA, Manning NW, Cheung A, Kozak O, Yan B, Mitchell PJ, Ebersole K, Toth G, Gooch M, Gibson D, Sahlein DH, Amuluru K, Abdulrazzak MA, Duncan K, Defta D, Shaker F, Al-Shaibi F, Ray A, Sunshine J, Hu YC, Burkhardt JK, Mir O, Alenzi B, Kass-Hout T, Gupta R, Tjoumakaris SI, Jabbour PM, Nguyen TN, Fifi JT, Pereira VM, Bambakidis N, Hill MD, Grotta JC, Ribo M, Campbell BCV, Samaniego EA, Sarraj A. Endovascular Thrombectomy for Extracranial Internal Carotid Artery Occlusions With Large Ischemic Strokes: Insights From the SELECT2 Trial. Neurology. 2025 Feb 25;104(4):e210269. doi: 10.1212/WNL.0000000000210269. Epub 2025 Jan 27.
- Derived from this study: PubMed 39744837Tsai JP, Nguyen TN, Pujara DK, Fifi JT, Sundararajan S, Schaafsma JD, Perez de la Ossa N, Abraham MG, Chen M, Hussain MS, Ortega-Gutierrez S, Johns HT, Duncan KR, Churilov L, Lechtenberg CG, Slavin SJ, Opaskar A, de Lera M, Lara-Rodriguez B, Quesada H, Fournier LE, Defta DM, Shaker F, Sitton CW, Sharrief AZ, Grotta JC, Hill MD, Ribo M, Hassan AE, Campbell BCV, Sila C, Tjoumakaris SI, Sarraj A; for SELECT2 Investigators. Sex-Based Differences in Endovascular Thrombectomy Outcomes for Large Ischemic Stroke: A SELECT2 Subanalysis. Stroke. 2025 Feb;56(2):294-304. doi: 10.1161/STROKEAHA.124.049307. Epub 2025 Jan 2.
- Derived from this study: PubMed 39047249Chen H, Malhotra A, Gandhi D. Thrombectomy for Large Strokes. N Engl J Med. 2024 Jul 25;391(4):378-379. doi: 10.1056/NEJMc2406965. No abstract available.
- Derived from this study: PubMed 39039739Pujara DK, Hussain MS, Abraham MG, Ortega-Gutierrez S, Chen M, Kasner SE, Churilov L, Sitton CW, Blackburn S, Sundararajan S, Hu YC, Herial NA, Budzik RF, Hicks WJ, Arenillas JF, Tsai JP, Kozak O, Cordato DJ, Manning NW, Hanel RA, Aghaebrahim AN, Wu TY, Cardona Portela P, Perez de la Ossa N, Schaafsma JD, Blasco J, Sangha N, Warach S, Gandhi CD, Al-Mufti F, Kleinig TJ, Al-Shaibi F, Duncan KR, Shaker F, Johns H, Xiong W, DeGeorgia M, Opaskar A, Sunshine J, Ray A, Jabbour P, Bambakidis N, Sila C, Nguyen TN, Grotta JC, Hassan AE, Ribo M, Hill MD, Campbell BC, Sarraj A; For SELECT2 Investigators. Anticoagulation Use and Endovascular Thrombectomy in Patients with Large Core Stroke: A Secondary Analysis of the SELECT2 Trial. Ann Neurol. 2024 Nov;96(5):887-894. doi: 10.1002/ana.27021. Epub 2024 Jul 22.
- Derived from this study: PubMed 38363872Sarraj A, Hill MD, Hussain MS, Abraham MG, Ortega-Gutierrez S, Chen M, Kasner SE, Churilov L, Pujara DK, Johns H, Blackburn S, Sundararajan S, Hu YC, Herial NA, Budzik RF, Hicks WJ, Arenillas JF, Tsai JP, Kozak O, Cordato DJ, Hanel RA, Wu TY, Portela PC, Gandhi CD, Al-Mufti F, Maali L, Gibson D, Perez de la Ossa N, Schaafsma JD, Blasco J, Sangha N, Warach S, Kleinig TJ, Shaker F, Sitton CW, Nguyen T, Fifi JT, Jabbour P, Furlan A, Lansberg MG, Tsivgoulis G, Sila C, Bambakidis N, Davis S, Wechsler L, Albers GW, Grotta JC, Ribo M, Campbell BC, Hassan AE; SELECT2 Investigators; SELECT2 Collaborators; Vora N, Manning NW, Cheung A, Aghaebrahim AN, Paipa Merchan AJ, Sahlein D, Requena Ruiz M, Elijovich L, Arthur A, Al-Shaibi F, Samaniego EA, Duncan KR, Opaskar A, Ray A, Xiong W, Sunshine J, DeGeorgia M, Tjoumakaris S, Mendes Pereira V; SELECT2 Collaborators. Endovascular Thrombectomy Treatment Effect in Direct vs Transferred Patients With Large Ischemic Strokes: A Prespecified Analysis of the SELECT2 Trial. JAMA Neurol. 2024 Feb 8;81(4):327-35. doi: 10.1001/jamaneurol.2024.0206. Online ahead of print.
- Derived from this study: PubMed 38346442Sarraj A, Abraham MG, Hassan AE, Blackburn S, Kasner SE, Ortega-Gutierrez S, Hussain MS, Chen M, Johns H, Churilov L, Pujara DK, Shaker F, Maali L, Cardona Portela P, Herial NA, Gibson D, Kozak O, Arenillas JF, Yan B, Perez de la Ossa N, Sundararajan S, Hu YC, Cordato DJ, Manning NW, Hanel RA, Aghaebrahim AN, Budzik RF, Hicks WJ, Blasco J, Wu TY, Tsai JP, Schaafsma JD, Gandhi CD, Al-Mufti F, Sangha N, Warach S, Kleinig TJ, Yogendrakumar V, Ng F, Samaniego EA, Abdulrazzak MA, Parsons MW, Rahbar MH, Nguyen TN, Fifi JT, Mendes Pereira V, Lansberg MG, Albers GW, Furlan AJ, Jabbour P, Sitton CW, Sila C, Bambakidis N, Davis SM, Wechsler L, Hill MD, Grotta JC, Ribo M, Campbell BCV; SELECT2 Investigators. Endovascular thrombectomy plus medical care versus medical care alone for large ischaemic stroke: 1-year outcomes of the SELECT2 trial. Lancet. 2024 Feb 24;403(10428):731-740. doi: 10.1016/S0140-6736(24)00050-3. Epub 2024 Feb 9.
- Derived from this study: PubMed 38324414Sarraj A, Hassan AE, Abraham MG, Ortega-Gutierrez S, Kasner SE, Hussain MS, Chen M, Churilov L, Johns H, Sitton CW, Yogendrakumar V, Ng FC, Pujara DK, Blackburn S, Sundararajan S, Hu YC, Herial NA, Arenillas JF, Tsai JP, Budzik RF, Hicks WJ, Kozak O, Yan B, Cordato DJ, Manning NW, Parsons MW, Cheung A, Hanel RA, Aghaebrahim AN, Wu TY, Portela PC, Gandhi CD, Al-Mufti F, Perez de la Ossa N, Schaafsma JD, Blasco J, Sangha N, Warach S, Kleinig TJ, Shaker F, Al Shaibi F, Toth G, Abdulrazzak MA, Sharma G, Ray A, Sunshine J, Opaskar A, Duncan KR, Xiong W, Samaniego EA, Maali L, Lechtenberg CG, Renu A, Vora N, Nguyen T, Fifi JT, Tjoumakaris SI, Jabbour P, Tsivgoulis G, Pereira VM, Lansberg MG, DeGeorgia M, Sila CA, Bambakidis N, Hill MD, Davis SM, Wechsler L, Grotta JC, Ribo M, Albers GW, Campbell BC; SELECT2 Investigators. Endovascular Thrombectomy for Large Ischemic Stroke Across Ischemic Injury and Penumbra Profiles. JAMA. 2024 Mar 5;331(9):750-763. doi: 10.1001/jama.2024.0572.
- Derived from this study: PubMed 36762865Sarraj A, Hassan AE, Abraham MG, Ortega-Gutierrez S, Kasner SE, Hussain MS, Chen M, Blackburn S, Sitton CW, Churilov L, Sundararajan S, Hu YC, Herial NA, Jabbour P, Gibson D, Wallace AN, Arenillas JF, Tsai JP, Budzik RF, Hicks WJ, Kozak O, Yan B, Cordato DJ, Manning NW, Parsons MW, Hanel RA, Aghaebrahim AN, Wu TY, Cardona-Portela P, Perez de la Ossa N, Schaafsma JD, Blasco J, Sangha N, Warach S, Gandhi CD, Kleinig TJ, Sahlein D, Elijovich L, Tekle W, Samaniego EA, Maali L, Abdulrazzak MA, Psychogios MN, Shuaib A, Pujara DK, Shaker F, Johns H, Sharma G, Yogendrakumar V, Ng FC, Rahbar MH, Cai C, Lavori P, Hamilton S, Nguyen T, Fifi JT, Davis S, Wechsler L, Pereira VM, Lansberg MG, Hill MD, Grotta JC, Ribo M, Campbell BC, Albers GW; SELECT2 Investigators. Trial of Endovascular Thrombectomy for Large Ischemic Strokes. N Engl J Med. 2023 Apr 6;388(14):1259-1271. doi: 10.1056/NEJMoa2214403. Epub 2023 Feb 10.
- Derived from this study: PubMed 35450966Sarraj A, Campbell BCV, Christensen S, Sitton CW, Khanpara S, Riascos RF, Pujara D, Shaker F, Sharma G, Lansberg MG, Albers GW; SELECT Investigators. Accuracy of CT Perfusion-Based Core Estimation of Follow-up Infarction: Effects of Time Since Last Known Well. Neurology. 2022 May 24;98(21):e2084-e2096. doi: 10.1212/WNL.0000000000200269. Epub 2022 Apr 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amrou Sarraj, MD principal investigator
Case Western Reserve University - University Hospitals Cleveland Medical Center
(Australia and Oceania) Bruce CV Campbell, MBBS PhD principal investigator
Melbourne Health
(Europe) Marc Ribo, MD principal investigator
Vall d'Hebron University Hospital, Barcelona
31 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Thrombectomy and Medical Management in people with Acute Ischemic Stroke, run by University Hospitals Cleveland Medical Center at 31 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Spain, Australia, Canada, New Zealand and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of Disability/Dependence as Measured by the Modified Rankin Scale (mRS) Score (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03876457, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.