Trial Outcomes & Findings for SELECT2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke (NCT NCT03876457)

NCT ID: NCT03876457

Last Updated: 2024-11-21

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 352 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2024-11-21

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	178	174
Overall Study COMPLETED	177	171
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	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.	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.
Overall Study Lost to Follow-up	1	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Endovascular Thrombectomy Plus Medical Management n=178 Participants 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.	Medical Management n=174 Participants 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.	Total n=352 Participants Total of all reporting groups
Age, Continuous	65.1 years STANDARD_DEVIATION 12.7 • n=5 Participants	65.3 years STANDARD_DEVIATION 12.6 • n=7 Participants	65.2 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	74 Participants n=7 Participants	145 Participants n=5 Participants
Sex: Female, Male Male	107 Participants n=5 Participants	100 Participants n=7 Participants	207 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=5 Participants	31 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	136 Participants n=5 Participants	134 Participants n=7 Participants	270 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) White	132 Participants n=5 Participants	130 Participants n=7 Participants	262 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Endovascular Thrombectomy Plus Medical Management n=178 Participants 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.	Medical Management n=174 Participants 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.
Degree of Disability/Dependence as Measured by the Modified Rankin Scale (mRS) Score	4 scores on a scale Interval 3.0 to 6.0	5 scores on a scale Interval 4.0 to 6.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Endovascular Thrombectomy Plus Medical Management n=177 Participants 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.	Medical Management n=171 Participants 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.
Number of Participants That Achieved Functional Independence as Measured by a mRS Score of 0-2 at 90-day Follow-up	36 Participants	12 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Endovascular Thrombectomy Plus Medical Management n=177 Participants 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.	Medical Management n=171 Participants 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.
Number of Participants That Achieved Independent Ambulation as Measured by a mRS Score of 0-3 at 90-day Follow-up	67 Participants	32 Participants

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Measure	Endovascular Thrombectomy Plus Medical Management n=178 Participants 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.	Medical Management n=174 Participants 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.
Number of Patients That Suffered a Symptomatic Intracranial Hemorrhage (sICH) as Measured by the SITS-MOST Criteria	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Measure	Endovascular Thrombectomy Plus Medical Management n=178 Participants 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.	Medical Management n=174 Participants 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.
Number of Participants With Neurological Worsening Defined as a ≥4-point Increase on the NIHSS Score Due to the Stroke Itself	44 Participants	27 Participants

SECONDARY outcome

Timeframe: 90 days

Outcome measures

Measure	Endovascular Thrombectomy Plus Medical Management n=177 Participants 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.	Medical Management n=171 Participants 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.
Number of Mortalities Within 90-day Follow-up	68 Mortalities	71 Mortalities

SECONDARY outcome

Timeframe: 24 hours

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

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

Outcome measures

Measure	Endovascular Thrombectomy Plus Medical Management n=178 Participants 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.	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.
Number of Procedural Complications	30 Procedural complications	—

SECONDARY outcome

Timeframe: at the end of endovascular thrombectomy procedure

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

Outcome measures

Measure	Endovascular Thrombectomy Plus Medical Management n=178 Participants 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.	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.
Successful Reperfusion in the EVT Group, Defined as Modified Thrombolysis in Cerebral Ischemia (mTICI) Grade of 2b or Higher	142 Successful reperfusions	—

SECONDARY outcome

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

Outcome measures

Measure	Endovascular Thrombectomy Plus Medical Management n=178 Participants 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.	Medical Management n=174 Participants 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.
Discharge Location Discharged to inpatient rehab facility	72 Participants	65 Participants
Discharge Location Discharged to skilled nursing facility	23 Participants	20 Participants
Discharge Location Discharged to home	19 Participants	10 Participants
Discharge Location Discharged to acute care facility	11 Participants	16 Participants
Discharge Location Discharged to hospice or home hospice	11 Participants	19 Participants
Discharge Location Discharged to in-hospital death	42 Participants	44 Participants

SECONDARY outcome

Timeframe: 24 hours

Population: 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.

Outcome measures

Measure	Endovascular Thrombectomy Plus Medical Management n=174 Participants 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.	Medical Management n=172 Participants 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.
Number of Participants That Showed Early Neurological Improvement, Defined as Improvement of ≥8 Points on NIHSS at 24 Hours of Presentation or an NIHSS of 0-1	20 Participants	13 Participants

SECONDARY outcome

Timeframe: 90 days

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.

Outcome measures

Measure	Endovascular Thrombectomy Plus Medical Management n=177 Participants 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.	Medical Management n=171 Participants 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.
Quality of Life Score, as Measured Using NeuroQOL at 90-day Follow-up Mobility domain	35.2 score on a scale Interval 23.9 to 43.9	25.1 score on a scale Interval 16.5 to 33.0
Quality of Life Score, as Measured Using NeuroQOL at 90-day Follow-up Depression domain	47.9 score on a scale Interval 43.1 to 54.3	53.6 score on a scale Interval 46.8 to 57.4
Quality of Life Score, as Measured Using NeuroQOL at 90-day Follow-up Social domain	37.1 score on a scale Interval 32.7 to 42.0	33.5 score on a scale Interval 27.7 to 37.8
Quality of Life Score, as Measured Using NeuroQOL at 90-day Follow-up Cognitive domain	41.9 score on a scale Interval 35.0 to 49.6	37.9 score on a scale Interval 30.9 to 42.9

SECONDARY outcome

Timeframe: 1 year

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

Outcome measures

Measure	Endovascular Thrombectomy Plus Medical Management n=178 Participants 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.	Medical Management n=174 Participants 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.
The 1-year Functional Outcome, as Measured by the Modified Rankin Scale Score	5 score on a scale Interval 3.0 to 6.0	6 score on a scale Interval 4.0 to 6.0

SECONDARY outcome

Timeframe: 1 year

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

Outcome measures

Measure	Endovascular Thrombectomy Plus Medical Management n=170 Participants 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.	Medical Management n=159 Participants 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.
Number of Participants With Functional Independence, Defined as mRS Score of 0-2 at 1-year Follow-up	40 Participants	9 Participants

SECONDARY outcome

Timeframe: 1 year

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

Outcome measures

Measure	Endovascular Thrombectomy Plus Medical Management n=170 Participants 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.	Medical Management n=159 Participants 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.
Number of Participants With Independent Ambulation, Defined as mRS Score of 0-3 at 1-year Follow-up	63 Participants	29 Participants

SECONDARY outcome

Timeframe: 1 year

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

Outcome measures

Measure	Endovascular Thrombectomy Plus Medical Management n=170 Participants 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.	Medical Management n=159 Participants 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.
Quality of Life Score, as Measured Using NeuroQOL at 1 Year Follow-up Mobility domain	40.8 score on a scale Interval 26.2 to 48.6	27.2 score on a scale Interval 19.2 to 38.3
Quality of Life Score, as Measured Using NeuroQOL at 1 Year Follow-up Depression domain	45.3 score on a scale Interval 36.9 to 55.1	52.1 score on a scale Interval 49.7 to 57.4
Quality of Life Score, as Measured Using NeuroQOL at 1 Year Follow-up Social domain	40.6 score on a scale Interval 33.5 to 44.7	35 score on a scale Interval 30.5 to 41.3
Quality of Life Score, as Measured Using NeuroQOL at 1 Year Follow-up Cognitive domain	46 score on a scale Interval 37.0 to 59.0	38.9 score on a scale Interval 33.0 to 46.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 7 days

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

Outcome measures

Measure	Endovascular Thrombectomy Plus Medical Management n=177 Participants 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.	Medical Management n=174 Participants 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.
Infarct Volume on MRI DWI Sequence (or CT if MRI Not Feasible) up to 7 Days After Randomization	178 mL Interval 109.0 to 253.0	168.5 mL Interval 124.0 to 268.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours to 7 days

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

Outcome measures

Measure	Endovascular Thrombectomy Plus Medical Management n=177 Participants 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.	Medical Management n=174 Participants 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.
Lesion Growth (Difference Between the Ischemic Core on Baseline Imaging and the Follow-up Infarct Volume)	78 mL Interval 22.0 to 131.0	65.5 mL Interval 24.0 to 110.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours

Outcome measures

Measure	Endovascular Thrombectomy Plus Medical Management n=178 Participants 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.	Medical Management n=174 Participants 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.
Number of Participants Who Suffered Parenchymal Hemorrhage Type 2	2 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours

Outcome measures

Measure	Endovascular Thrombectomy Plus Medical Management n=178 Participants 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.	Medical Management n=174 Participants 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.
Number of Participants Who Suffered a Subarachnoid Hemorrhage	4 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

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

Outcome measures

Measure	Endovascular Thrombectomy Plus Medical Management n=178 Participants 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.	Medical Management n=174 Participants 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.
Number of Participants Who Had a Hemicraniectomy During Index Hospitalization	29 Participants	26 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 90-day follow up visit

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.

Outcome measures

Measure	Endovascular Thrombectomy Plus Medical Management n=178 Participants 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.	Medical Management n=174 Participants 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.
Length of Hospital Stay	9 Days Interval 5.0 to 17.0	8 Days Interval 5.0 to 13.0

Adverse Events

Endovascular Thrombectomy Plus Medical Management

Serious events: 129 serious events

Other events: 77 other events

Deaths: 68 deaths

Medical Management

Serious events: 123 serious events

Other events: 59 other events

Deaths: 71 deaths

Serious adverse events

Measure	Endovascular Thrombectomy Plus Medical Management n=178 participants at risk 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.	Medical Management n=174 participants at risk 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.
Vascular disorders Access Site Complication - Arterial Occlusion	1.7% 3/178 • 90 days	0.00% 0/174 • 90 days
Vascular disorders Access Site Complication - Hematoma	0.56% 1/178 • 90 days	0.00% 0/174 • 90 days
Vascular disorders Access Site Complication - Infection	0.56% 1/178 • 90 days	0.00% 0/174 • 90 days
Vascular disorders Acute Arterial Occlusion (Acute Limb Ischemia)	1.1% 2/178 • 90 days	0.57% 1/174 • 90 days
Renal and urinary disorders Acute kidney injury	5.1% 9/178 • 90 days	5.2% 9/174 • 90 days
Nervous system disorders Cerebral Edema with Midline Shift	36.0% 64/178 • 90 days	32.8% 57/174 • 90 days
Nervous system disorders Cerebritis	0.56% 1/178 • 90 days	0.00% 0/174 • 90 days
Respiratory, thoracic and mediastinal disorders COVID-19	2.8% 5/178 • 90 days	2.9% 5/174 • 90 days
Vascular disorders Deep Vein Thrombosis	1.1% 2/178 • 90 days	1.1% 2/174 • 90 days
Nervous system disorders Delirium, Cognitive Dysfunction	5.1% 9/178 • 90 days	2.9% 5/174 • 90 days
Cardiac disorders Endocarditis	0.00% 0/178 • 90 days	0.57% 1/174 • 90 days
Cardiac disorders Heart failure	3.9% 7/178 • 90 days	4.6% 8/174 • 90 days
Endocrine disorders Hyperglycemic Hyperosmolar State	0.00% 0/178 • 90 days	0.57% 1/174 • 90 days
Respiratory, thoracic and mediastinal disorders Lower respiratory infection (pneumonia)	10.1% 18/178 • 90 days	12.1% 21/174 • 90 days
Cardiac disorders Myocardial infarction	1.1% 2/178 • 90 days	1.7% 3/174 • 90 days
Nervous system disorders Neurological Deterioration	24.7% 44/178 • 90 days	15.5% 27/174 • 90 days
Nervous system disorders New Stroke	3.4% 6/178 • 90 days	2.9% 5/174 • 90 days
Cardiac disorders Pericardial effusion	0.56% 1/178 • 90 days	0.00% 0/174 • 90 days
Nervous system disorders Progression of Disease, Palliative Care Decision	14.0% 25/178 • 90 days	17.8% 31/174 • 90 days
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.2% 4/178 • 90 days	1.7% 3/174 • 90 days
Reproductive system and breast disorders Respiratory failure	16.9% 30/178 • 90 days	10.9% 19/174 • 90 days
Infections and infestations Sepsis, Systemic inflammatory response syndrome	6.2% 11/178 • 90 days	5.2% 9/174 • 90 days
Nervous system disorders Symptomatic Intracranial Hemorrhage	0.56% 1/178 • 90 days	1.1% 2/174 • 90 days
Renal and urinary disorders Urinary Tract Infection	6.7% 12/178 • 90 days	7.5% 13/174 • 90 days
Skin and subcutaneous tissue disorders Wound Infection	0.00% 0/178 • 90 days	1.1% 2/174 • 90 days

Other adverse events

Measure	Endovascular Thrombectomy Plus Medical Management n=178 participants at risk 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.	Medical Management n=174 participants at risk 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.
General disorders Alcohol Withdrawal	0.56% 1/178 • 90 days	0.57% 1/174 • 90 days
Blood and lymphatic system disorders Anemia	4.5% 8/178 • 90 days	2.3% 4/174 • 90 days
Psychiatric disorders Anxiety	0.00% 0/178 • 90 days	0.57% 1/174 • 90 days
Nervous system disorders Asymptomatic Intracranial Hemorrhage	0.00% 0/178 • 90 days	0.57% 1/174 • 90 days
Cardiac disorders Cardiac Arrythmia	11.8% 21/178 • 90 days	11.5% 20/174 • 90 days
Nervous system disorders Carotid Cavernous Fistula	0.56% 1/178 • 90 days	0.00% 0/174 • 90 days
Nervous system disorders Cerebral Vasospasm	0.56% 1/178 • 90 days	0.00% 0/174 • 90 days
Nervous system disorders Clonus	0.56% 1/178 • 90 days	0.00% 0/174 • 90 days
General disorders Dehydration	0.56% 1/178 • 90 days	0.00% 0/174 • 90 days
Psychiatric disorders Depression	1.7% 3/178 • 90 days	0.00% 0/174 • 90 days
General disorders Diaphoresis	0.56% 1/178 • 90 days	0.57% 1/174 • 90 days
General disorders Dizziness	0.56% 1/178 • 90 days	0.00% 0/174 • 90 days
Nervous system disorders Encephalopathy	0.56% 1/178 • 90 days	0.57% 1/174 • 90 days
Nervous system disorders Epidural Hemorrhage	0.00% 0/178 • 90 days	0.57% 1/174 • 90 days
Vascular disorders Epistaxis	1.1% 2/178 • 90 days	0.00% 0/174 • 90 days
Nervous system disorders Evolution of infarction on the brain imaging	4.5% 8/178 • 90 days	4.6% 8/174 • 90 days
Eye disorders Eye Complications	1.1% 2/178 • 90 days	0.00% 0/174 • 90 days
General disorders Fall	1.1% 2/178 • 90 days	2.3% 4/174 • 90 days
General disorders Fever	3.9% 7/178 • 90 days	5.2% 9/174 • 90 days
Gastrointestinal disorders Gastrointestinal Complications	10.7% 19/178 • 90 days	4.6% 8/174 • 90 days
Cardiac disorders Hallucination	0.56% 1/178 • 90 days	0.00% 0/174 • 90 days
General disorders Headache	5.1% 9/178 • 90 days	1.1% 2/174 • 90 days
Vascular disorders Hematoma	1.1% 2/178 • 90 days	0.57% 1/174 • 90 days
Cardiac disorders Hypertension	0.56% 1/178 • 90 days	1.7% 3/174 • 90 days
Cardiac disorders Hypotension	2.2% 4/178 • 90 days	0.57% 1/174 • 90 days
Gastrointestinal disorders Ileus	0.56% 1/178 • 90 days	0.00% 0/174 • 90 days
General disorders Insomnia	1.7% 3/178 • 90 days	0.00% 0/174 • 90 days
Gastrointestinal disorders Lactose intolerance reaction	0.56% 1/178 • 90 days	0.00% 0/174 • 90 days
Immune system disorders Laryngeal Edema	0.56% 1/178 • 90 days	0.00% 0/174 • 90 days
General disorders Lethargy	2.2% 4/178 • 90 days	2.3% 4/174 • 90 days
Hepatobiliary disorders Liver Injury	2.8% 5/178 • 90 days	0.57% 1/174 • 90 days
Musculoskeletal and connective tissue disorders Musculoskeletal Complications	5.1% 9/178 • 90 days	3.4% 6/174 • 90 days
General disorders Nausea	2.2% 4/178 • 90 days	1.1% 2/174 • 90 days
Cardiac disorders near syncopal episode	0.56% 1/178 • 90 days	0.00% 0/174 • 90 days
Vascular disorders Non-Cerebral Thrombotic Events	2.8% 5/178 • 90 days	0.57% 1/174 • 90 days
Eye disorders ocular nerve damage	0.56% 1/178 • 90 days	0.00% 0/174 • 90 days
Renal and urinary disorders Other Renal Complications	7.9% 14/178 • 90 days	4.0% 7/174 • 90 days
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.2% 4/178 • 90 days	1.1% 2/174 • 90 days
Nervous system disorders Progression of Disease	9.0% 16/178 • 90 days	6.3% 11/174 • 90 days
Nervous system disorders SDH	0.56% 1/178 • 90 days	0.00% 0/174 • 90 days
Nervous system disorders Seizures	1.1% 2/178 • 90 days	1.1% 2/174 • 90 days
Skin and subcutaneous tissue disorders Skin Complications	5.6% 10/178 • 90 days	0.57% 1/174 • 90 days
Blood and lymphatic system disorders Splenic infarct	0.56% 1/178 • 90 days	0.00% 0/174 • 90 days
Vascular disorders Stent Thrombosis	0.56% 1/178 • 90 days	0.00% 0/174 • 90 days
Vascular disorders Symptomatic Carotid Artery Stenosis	0.00% 0/178 • 90 days	0.57% 1/174 • 90 days
Endocrine disorders Syndrome of inappropriate ADH production	0.56% 1/178 • 90 days	0.00% 0/174 • 90 days
General disorders Thirst	0.56% 1/178 • 90 days	0.00% 0/174 • 90 days
Blood and lymphatic system disorders Thrombocytopenia	2.2% 4/178 • 90 days	0.00% 0/174 • 90 days
Ear and labyrinth disorders Tinnitus	0.56% 1/178 • 90 days	0.00% 0/174 • 90 days
Nervous system disorders Tremors	0.00% 0/178 • 90 days	0.57% 1/174 • 90 days
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	3.9% 7/178 • 90 days	0.00% 0/174 • 90 days
Reproductive system and breast disorders Uterine hemorrhage	0.56% 1/178 • 90 days	0.00% 0/174 • 90 days
Nervous system disorders Vessel dissection	2.2% 4/178 • 90 days	0.00% 0/174 • 90 days
Nervous system disorders Vessel perforation	1.1% 2/178 • 90 days	0.00% 0/174 • 90 days

Additional Information

Dr. Amrou Sarraj

University Hospitals Cleveland Medical Center

Phone: (216)844-0474

Email: Amrou.Sarraj@UHhospitals.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place