SELECT2: A Randomized Controlled Trial to Optimize Patien... | NCT03876457

Name	Class
Stryker Neurovascular	INDUSTRY
The University of Texas Health Science Center, Houston	OTHER

Label	Type	Description	Intervention Names
Endovascular Thrombectomy plus Medical Management	Experimental		Device: Endovascular Thrombectomy Other: Medical Management
Medical Management	Active Comparator		Other: Medical Management

Name	Type	Description	Arm Group Labels	Other Names
Endovascular Thrombectomy	Device	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.

Measure	Description	Time Frame
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	90 days

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Infarct Volume on MRI DWI Sequence (or CT if MRI Not Feasible) up to 7 Days After Randomization	Infarct volume on MRI DWI sequence (or CT if MRI not feasible) up to 7 days after randomization	Up to 7 days
Lesion Growth (Difference Between the Ischemic Core on Baseline Imaging and the Follow-up Infarct Volume)

Name	Affiliation	Role
Amrou Sarraj, MD	Case Western Reserve University - University Hospitals Cleveland Medical Center	Principal Investigator
(Australia and Oceania) Bruce CV Campbell, MBBS PhD	Melbourne Health	Principal Investigator
(Europe) Marc Ribo, MD	Vall d'Hebron University Hospital, Barcelona	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Kaiser Permanente		Los Angeles	California	90027	United States
Baptist Health

PubMed Identifier	Type	Citation	Retractions
41906875	Derived	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.
40570276

ID	Title	Description
FG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 4, 2021

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Degree of Disability/Dependence as Measured by the Modified Rankin Scale (mRS) Score

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

Posted

Median

95% Confidence Interval

scores on a scale

90 days

ID	Title	Description
OG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.
OG001	Medical Management	Medical Management: 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.

Units	Counts
Participants	OG000178 OG001174

Title

Denominators

Categories

Title	Measurements
	OG0004(3 to 6) OG0015(4 to 6)

Secondary

Number of Participants That Achieved Functional Independence as Measured by a mRS Score of 0-2 at 90-day Follow-up

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 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.

Score 6: Dead

Posted

Count of Participants

Participants

90 days

ID	Title	Description
OG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.

Secondary

Number of Participants That Achieved Independent Ambulation as Measured by a mRS Score of 0-3 at 90-day Follow-up

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 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.

Score 6: Dead

Posted

Count of Participants

Participants

90 days

ID	Title	Description
OG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.

Secondary

Number of Patients That Suffered a Symptomatic Intracranial Hemorrhage (sICH) as Measured by the SITS-MOST Criteria

Posted

Count of Participants

Participants

24 hours

ID	Title	Description
OG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.

Secondary

Number of Participants With Neurological Worsening Defined as a ≥4-point Increase on the NIHSS Score Due to the Stroke Itself

Posted

Count of Participants

Participants

24 hours

ID	Title	Description
OG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.

Secondary

Number of Mortalities Within 90-day Follow-up

Posted

Number

Mortalities

90 days

ID	Title	Description
OG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.
OG001	Medical Management

Secondary

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

Patients in the medical management group did not undergo procedure so no data was collected for that group.

Posted

Number

Procedural complications

24 hours

ID	Title	Description
OG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.

Secondary

Successful Reperfusion in the EVT Group, Defined as Modified Thrombolysis in Cerebral Ischemia (mTICI) Grade of 2b or Higher

Data was only collected for the Endovascular Thrombectomy plus Medical Management group

Posted

Number

Successful reperfusions

at the end of endovascular thrombectomy procedure

ID	Title	Description
OG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.

Secondary

Discharge Location

Posted

Count of Participants

Participants

day 5-7 after randomization/at discharge (whichever is later)

ID	Title	Description
OG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.
OG001

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

4 participants in the Endovascular Thrombectomy plus medical management, and 1 participant in the medical management group did not have enough data available to be included in the analysis.

Posted

Count of Participants

Participants

24 hours

ID	Title	Description
OG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.

Secondary

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.

Posted

Median

Inter-Quartile Range

score on a scale

90 days

ID	Title	Description
OG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.

Secondary

The 1-year Functional Outcome, as Measured by the Modified Rankin Scale Score

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 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.

Score 6: Dead

Posted

Median

Inter-Quartile Range

score on a scale

1 year

ID	Title	Description
OG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.

Secondary

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

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.

Secondary

Number of Participants With Independent Ambulation, Defined as mRS Score of 0-3 at 1-year Follow-up

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.

Secondary

Quality of Life Score, as Measured Using NeuroQOL at 1 Year Follow-up

Quality of Life scores in mobility, depression,social and cognitive domains

Posted

Mean

95% Confidence Interval

score on a scale

1 year

ID	Title	Description
OG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.

Other Pre-specified

Infarct Volume on MRI DWI Sequence (or CT if MRI Not Feasible) up to 7 Days After Randomization

Infarct volume on MRI DWI sequence (or CT if MRI not feasible) up to 7 days after randomization

Posted

Median

Inter-Quartile Range

Up to 7 days

ID	Title	Description
OG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.

Other Pre-specified

Lesion Growth (Difference Between the Ischemic Core on Baseline Imaging and the Follow-up Infarct Volume)

Lesion growth (difference between ischemic core on baseline imaging and the follow-up infarct volume)

Posted

Median

Inter-Quartile Range

24 hours to 7 days

ID	Title	Description
OG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.

Other Pre-specified

Number of Participants Who Suffered Parenchymal Hemorrhage Type 2

Posted

Count of Participants

Participants

24 hours

ID	Title	Description
OG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.
OG001

Other Pre-specified

Number of Participants Who Suffered a Subarachnoid Hemorrhage

Posted

Count of Participants

Participants

24 hours

ID	Title	Description
OG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.
OG001

Other Pre-specified

Number of Participants Who Had a Hemicraniectomy During Index Hospitalization

Posted

Count of Participants

Participants

day 5-7 after randomization/at discharge (whichever is later)

ID	Title	Description
OG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.

Other Pre-specified

Length of Hospital Stay

Was assessed if the patient was discharged at every follow-up visit to determine the length of the stay if the patient was not discharged at the time of previous follow-up visit.

Posted

Median

Inter-Quartile Range

Days

Up to 90-day follow up visit

ID	Title	Description
OG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.

Term	Organ System	Assessment Type	Statistical Information
Access Site Complication - Arterial Occlusion	Vascular disorders	Systematic Assessment	EG0003 affected178 at risk EG0010 affected174 at risk
Access Site Complication - Hematoma	Vascular disorders	Systematic Assessment	EG0001 affected178 at risk EG0010 affected174 at risk
Access Site Complication - Infection	Vascular disorders	Systematic Assessment	EG0001 affected178 at risk EG0010 affected174 at risk
Acute Arterial Occlusion (Acute Limb Ischemia)	Vascular disorders	Systematic Assessment	EG0002 affected178 at risk EG0011 affected174 at risk
Acute kidney injury	Renal and urinary disorders	Systematic Assessment	EG0009 affected178 at risk EG0019 affected174 at risk
Cerebral Edema with Midline Shift	Nervous system disorders	Systematic Assessment	EG00064 affected178 at risk EG00157 affected174 at risk
Cerebritis	Nervous system disorders	Systematic Assessment	EG0001 affected178 at risk EG0010 affected174 at risk
COVID-19	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0005 affected178 at risk EG0015 affected174 at risk
Deep Vein Thrombosis	Vascular disorders	Systematic Assessment	EG0002 affected178 at risk EG0012 affected174 at risk
Delirium, Cognitive Dysfunction	Nervous system disorders	Systematic Assessment	EG0009 affected178 at risk EG0015 affected174 at risk
Endocarditis	Cardiac disorders	Systematic Assessment	EG0000 affected178 at risk EG0011 affected174 at risk
Heart failure	Cardiac disorders	Systematic Assessment	EG0007 affected178 at risk EG0018 affected174 at risk
Hyperglycemic Hyperosmolar State	Endocrine disorders	Systematic Assessment	EG0000 affected178 at risk EG0011 affected174 at risk
Lower respiratory infection (pneumonia)	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00018 affected178 at risk EG00121 affected174 at risk
Myocardial infarction	Cardiac disorders	Systematic Assessment	EG0002 affected178 at risk EG0013 affected174 at risk
Neurological Deterioration	Nervous system disorders	Systematic Assessment	EG00044 affected178 at risk EG00127 affected174 at risk
New Stroke	Nervous system disorders	Systematic Assessment	EG0006 affected178 at risk EG0015 affected174 at risk
Pericardial effusion	Cardiac disorders	Systematic Assessment	EG0001 affected178 at risk EG0010 affected174 at risk
Progression of Disease, Palliative Care Decision	Nervous system disorders	Systematic Assessment	EG00025 affected178 at risk EG00131 affected174 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 affected178 at risk EG0013 affected174 at risk
Respiratory failure	Reproductive system and breast disorders	Systematic Assessment	EG00030 affected178 at risk EG00119 affected174 at risk
Sepsis, Systemic inflammatory response syndrome	Infections and infestations	Systematic Assessment	EG00011 affected178 at risk EG0019 affected174 at risk
Symptomatic Intracranial Hemorrhage	Nervous system disorders	Systematic Assessment	EG0001 affected178 at risk EG0012 affected174 at risk
Urinary Tract Infection	Renal and urinary disorders	Systematic Assessment	EG00012 affected178 at risk EG00113 affected174 at risk
Wound Infection	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected178 at risk EG0012 affected174 at risk

Term	Organ System	Assessment Type	Statistical Information
Alcohol Withdrawal	General disorders	Systematic Assessment	EG0001 affected178 at risk EG0011 affected174 at risk
Anemia	Blood and lymphatic system disorders	Systematic Assessment	EG0008 affected178 at risk EG0014 affected174 at risk
Anxiety	Psychiatric disorders	Systematic Assessment	EG0000 affected178 at risk EG0011 affected174 at risk
Asymptomatic Intracranial Hemorrhage	Nervous system disorders	Systematic Assessment	EG0000 affected178 at risk EG0011 affected174 at risk
Cardiac Arrythmia	Cardiac disorders	Systematic Assessment	EG00021 affected178 at risk EG00120 affected174 at risk
Carotid Cavernous Fistula	Nervous system disorders	Systematic Assessment	EG0001 affected178 at risk EG0010 affected174 at risk
Cerebral Vasospasm	Nervous system disorders	Systematic Assessment	EG0001 affected178 at risk EG0010 affected174 at risk
Clonus	Nervous system disorders	Systematic Assessment	EG0001 affected178 at risk EG0010 affected174 at risk
Dehydration	General disorders	Systematic Assessment	EG0001 affected178 at risk EG0010 affected174 at risk
Depression	Psychiatric disorders	Systematic Assessment	EG0003 affected178 at risk EG0010 affected174 at risk
Diaphoresis	General disorders	Systematic Assessment	EG0001 affected178 at risk EG0011 affected174 at risk
Dizziness	General disorders	Systematic Assessment	EG0001 affected178 at risk EG0010 affected174 at risk
Encephalopathy	Nervous system disorders	Systematic Assessment	EG0001 affected178 at risk EG0011 affected174 at risk
Epidural Hemorrhage	Nervous system disorders	Systematic Assessment	EG0000 affected178 at risk EG0011 affected174 at risk
Epistaxis	Vascular disorders	Systematic Assessment	EG0002 affected178 at risk EG0010 affected174 at risk
Evolution of infarction on the brain imaging	Nervous system disorders	Systematic Assessment	EG0008 affected178 at risk EG0018 affected174 at risk
Eye Complications	Eye disorders	Systematic Assessment	EG0002 affected178 at risk EG0010 affected174 at risk
Fall	General disorders	Systematic Assessment	EG0002 affected178 at risk EG0014 affected174 at risk
Fever	General disorders	Systematic Assessment	EG0007 affected178 at risk EG0019 affected174 at risk
Gastrointestinal Complications	Gastrointestinal disorders	Systematic Assessment	EG00019 affected178 at risk EG0018 affected174 at risk
Hallucination	Cardiac disorders	Systematic Assessment	EG0001 affected178 at risk EG0010 affected174 at risk
Headache	General disorders	Systematic Assessment	EG0009 affected178 at risk EG0012 affected174 at risk
Hematoma	Vascular disorders	Systematic Assessment	EG0002 affected178 at risk EG0011 affected174 at risk
Hypertension	Cardiac disorders	Systematic Assessment	EG0001 affected178 at risk EG0013 affected174 at risk
Hypotension	Cardiac disorders	Systematic Assessment	EG0004 affected178 at risk EG0011 affected174 at risk
Ileus	Gastrointestinal disorders	Systematic Assessment	EG0001 affected178 at risk EG0010 affected174 at risk
Insomnia	General disorders	Systematic Assessment	EG0003 affected178 at risk EG0010 affected174 at risk
Lactose intolerance reaction	Gastrointestinal disorders	Systematic Assessment	EG0001 affected178 at risk EG0010 affected174 at risk
Laryngeal Edema	Immune system disorders	Systematic Assessment	EG0001 affected178 at risk EG0010 affected174 at risk
Lethargy	General disorders	Systematic Assessment	EG0004 affected178 at risk EG0014 affected174 at risk
Liver Injury	Hepatobiliary disorders	Systematic Assessment	EG0005 affected178 at risk EG0011 affected174 at risk
Musculoskeletal Complications	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0009 affected178 at risk EG0016 affected174 at risk
Nausea	General disorders	Systematic Assessment	EG0004 affected178 at risk EG0012 affected174 at risk
near syncopal episode	Cardiac disorders	Systematic Assessment	EG0001 affected178 at risk EG0010 affected174 at risk
Non-Cerebral Thrombotic Events	Vascular disorders	Systematic Assessment	EG0005 affected178 at risk EG0011 affected174 at risk
ocular nerve damage	Eye disorders	Systematic Assessment	EG0001 affected178 at risk EG0010 affected174 at risk
Other Renal Complications	Renal and urinary disorders	Systematic Assessment	EG00014 affected178 at risk EG0017 affected174 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 affected178 at risk EG0012 affected174 at risk
Progression of Disease	Nervous system disorders	Systematic Assessment	EG00016 affected178 at risk EG00111 affected174 at risk
SDH	Nervous system disorders	Systematic Assessment	EG0001 affected178 at risk EG0010 affected174 at risk
Seizures	Nervous system disorders	Systematic Assessment	EG0002 affected178 at risk EG0012 affected174 at risk
Skin Complications	Skin and subcutaneous tissue disorders	Systematic Assessment	EG00010 affected178 at risk EG0011 affected174 at risk
Splenic infarct	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected178 at risk EG0010 affected174 at risk
Stent Thrombosis	Vascular disorders	Systematic Assessment	EG0001 affected178 at risk EG0010 affected174 at risk
Symptomatic Carotid Artery Stenosis	Vascular disorders	Systematic Assessment	EG0000 affected178 at risk EG0011 affected174 at risk
Syndrome of inappropriate ADH production	Endocrine disorders	Systematic Assessment	EG0001 affected178 at risk EG0010 affected174 at risk
Thirst	General disorders	Systematic Assessment	EG0001 affected178 at risk EG0010 affected174 at risk
Thrombocytopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0004 affected178 at risk EG0010 affected174 at risk
Tinnitus	Ear and labyrinth disorders	Systematic Assessment	EG0001 affected178 at risk EG0010 affected174 at risk
Tremors	Nervous system disorders	Systematic Assessment	EG0000 affected178 at risk EG0011 affected174 at risk
Upper Respiratory Infection	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0007 affected178 at risk EG0010 affected174 at risk
Uterine hemorrhage	Reproductive system and breast disorders	Systematic Assessment	EG0001 affected178 at risk EG0010 affected174 at risk
Vessel dissection	Nervous system disorders	Systematic Assessment	EG0004 affected178 at risk EG0010 affected174 at risk
Vessel perforation	Nervous system disorders	Systematic Assessment	EG0002 affected178 at risk EG0010 affected174 at risk

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D020399	Practice Management
D011364	Professional Practice
D009934	Organization and Administration
D006298	Health Services Administration

ID	Title	Description
BG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.
BG001	Medical Management	Medical Management: 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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Endovascular Thrombectomy Plus Medical Management	Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist. Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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.	68	178	129	178	77	178
EG001	Medical Management	Medical Management: 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.	71	174	123	174	59	174