Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3 (DEFUSE 3)

This is a study to evaluate the hypothesis that FDA cleared thrombectomy devices plus medical management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days when compared to medical management alone in appropriately selected subjects with the Target mismatch profile and an MCA (M1 segment) or ICA occlusion who can be randomized and have endovascular treatment initiated between 6-16 hours after last seen well.

Study Overview

• Status: Terminated
• Conditions: Cerebral Infarction; Stroke, Acute
• Intervention / Treatment: Procedure: Endovascular Thrombectomy; Device: Trevo Retriever; Device: Solitaire™ FR Revascularization Device; Device: Penumbra thrombectomy system; Device: Covidien MindFrame Capture Revascularization Device

Detailed Description

DEFUSE 3 is a prospective randomized Phase III multicenter controlled trial of patients with acute ischemic anterior circulation strokes due to large artery occlusion treated between 6-16 hours of stroke onset with endovascular thrombectomy therapy vs. control.

The primary endpoint, the modified Rankin Score, will be assessed at 3 months. The patients' participation in the study concludes at that time (3 months from stroke onset). The study will randomize up to 476 patients over 4 years. The purpose of DEFUSE 3 is to assess the safety and efficacy of thrombectomy in carefully selected patients in an extended time window. Only the devices listed in this protocol will be used. Selection of the specific device (or devices) is determined by the individual endovascular therapist.

Patients who meet the inclusion criteria will undergo either CT Perfusion/CT Angiogram or MR DWI/PWI/MRA studies prior to randomization. Patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile will be randomized in a 1:1 ratio to treatment with one or more DEFUSE 3 approved thrombectomy devices (only the devices listed in this protocol are approved for use in DEFUSE 3) plus standard medical therapy versus standard medical therapy alone. Patients who are enrolled, but not randomized, will receive standard therapy according to local guidelines. Baseline data, and information about early stroke therapies, will be captured for this group of patients.

Randomization of a maximum of 476 patients is planned. A novel adaptive design will identify, at interim analyses, the group with the best prospect for showing benefit from endovascular treatment, based on baseline core lesion volumes and the times since stroke onset. Interim analyses will be conducted at 200 and 340 patients, at which time the study may stop for efficacy/futility, or the inclusion criteria may be adjusted in the case of futility.

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233-1932
      • University of Alabama
  • California
    • Fresno, California, United States, 93721-1324
      • Community Regional Medical Center
    • La Jolla, California, United States, 92037-1205
      • Scripps Memorial Hospital
    • La Jolla, California, United States, 92093
      • UCSD Medical Center/Hillcrest Hospital
    • Los Angeles, California, United States, 90033-5313
      • Keck Hospital of University of Southern California
    • San Francisco, California, United States, 94110-3518
      • UCSF Medical Center, San Francisco, CA
    • Stanford, California, United States, 94305
      • Stanford University
    • Walnut Creek, California, United States, 94598-3122
      • John Muir Medical Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20010-3017
      • Medstar Washington Hospital Center
  • Illinois
    • Chicago, Illinois, United States, 60611-2908
      • Northwestern Memorial Hospital
  • Iowa
    • Iowa City, Iowa, United States, 52242-1009
      • University of Iowa Hospital and Clinics
  • Massachusetts
    • Boston, Massachusetts, United States, 02114-2621
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215-5400
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02115-6110
      • The Brigham and Women's Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5000
      • University of Michigan Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407-3723
      • Abbott Northwestern Hospital
    • Minneapolis, Minnesota, United States, 55415-1623
      • Hennepin County Medical Center
    • Minneapolis, Minnesota, United States, 55455-0363
      • University of Minnesota Medical Center, Fairview
  • New Jersey
    • Ridgewood, New Jersey, United States, 07450
      • The Valley Hospital
  • New York
    • New York, New York, United States, 10029-6504
      • Mount Sinai Hospital
    • New York, New York, United States, 10032-3725
      • New York Presbyterian Hospital at Columbia
    • New York, New York, United States, 10065-4870
      • NYP Weill Cornell Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45221-0222
      • University of Cincinnati
    • Cleveland, Ohio, United States, 44195-0001
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210-1280
      • Ohio State University Wexner Medical Center
    • Toledo, Ohio, United States, 43608-2603
      • Mercy Health St. Vincent Medical Center
  • Oregon
    • Portland, Oregon, United States, 97225-6603
      • Providence St. Vincent Medical Center
    • Portland, Oregon, United States, 97239-3098
      • Oregon Health & Science University Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-4238
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140-5103
      • Temple University Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02903-4923
      • Rhode Island Hospital
  • South Carolina
    • Columbia, South Carolina, United States, 29203-6863
      • Palmetto Health Richland
  • Tennessee
    • Nashville, Tennessee, United States, 37240-0001
      • Vanderbilt University
  • Texas
    • Austin, Texas, United States, 78701-1930
      • University Medical Center Brackenridge
    • Austin, Texas, United States, 78705-1006
      • Seton Medical Center/UT Southwestern
    • Houston, Texas, United States, 77030-5401
      • Memorial Hermann Texas Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84111-1470
      • Intermountain Medical Center
    • Salt Lake City, Utah, United States, 84112-9023
      • University of Utah Healthcare
  • Washington
    • Seattle, Washington, United States, 98104-2420
      • Harborview Medical Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53715-1218
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Clinical Inclusion Criteria:

1. Signs & symptoms consistent w/ the diagnosis of acute anterior circulation ischemic stroke
2. Age 18-90 years
3. Baseline NIHSSS is ≥ 6 and remains ≥6 immediately prior to randomization
4. Endovascular treatment can be initiated (femoral puncture) between 6 and 16 hours of stroke onset. Stroke onset is defined as the time the patient was last known to be at their neurologic baseline (wake-up strokes are eligible if they meet the above time limits).
5. modified Rankin Scale less than or equal to 2 prior to qualifying stroke (functionally independent for all ADLs)
6. Patient/Legally Authorized Representative has signed the Informed Consent form.

Clinical Exclusion Criteria:

1. Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 6 months.
2. Pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations
3. Pregnant
4. Unable to undergo a contrast brain perfusion scan with either MRI or CT
5. Known allergy to iodine that precludes an endovascular procedure
6. Treated with tPA >4.5 hours after time last known well
7. Treated with tPA 3-4.5 hours after last known well AND any of the following; age >80, current anticoagulant use, history of diabetes or prior stroke, NIHSS >25
8. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR > 3 (recent use of one of the new oral anticoagulants is not an exclusion if estimated GFR > 30 ml/min).
9. Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS
10. Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol)
11. Baseline platelet count < 50,000/uL
12. Severe, sustained hypertension (Systolic BP >185 mmHg or Diastolic BP >110 mmHg)
13. Current participation in another investigational drug or device study
14. Presumed septic embolus; suspicion of bacterial endocarditis
15. Clot retrieval attempted using a neurothrombectomy device prior to 6 hrs from symptom onset
16. Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.

Neuroimaging Inclusion Criteria:

1. ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial; with or without tandem MCA lesions) by MRA or CTA

   AND

2. Target Mismatch Profile on CT perfusion or MRI (ischemic core volume is < 70 ml, mismatch ratio is >/= 1.8 and mismatch volume* is >/= 15 ml)

Alternative neuroimaging inclusion criteria (if perfusion imaging or CTA/MRA is technically inadequate):

A) If CTA (or MRA) is technically inadequate:

Tmax>6s perfusion deficit consistent with an ICA or MCA-M1 occlusion AND Target Mismatch Profile (ischemic core volume is < 70 ml, mismatch ratio is >1.8 and mismatch volume is >15 ml as determined by RAPID software)

B) If MRP is technically inadequate:

ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial; with or without tandem MCA lesions) by MRA (or CTA, if MRA is technically inadequate and a CTA was performed within 60 minutes prior to the MRI) AND DWI lesion volume < 25 ml

C) If CTP is technically inadequate:

Patient can be screened with MRI and randomized if neuroimaging criteria are met.

Neuroimaging Exclusion Criteria:

1. ASPECTS score <6 on non-contrast CT (if patient is enrolled based on CT perfusion criteria)
2. Evidence of intracranial tumor (except small meningioma) acute intracranial hemorrhage, neoplasm, or arteriovenous malformation
3. Significant mass effect with midline shift
4. Evidence of internal carotid artery dissection that is flow limiting or aortic dissection
5. Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device
6. Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: endovascular thrombectomy therapy; Treatment with one or more thrombectomy devices (only the devices listed in this protocol are approved for use in DEFUSE 3) plus standard medical therapy for patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile. Devices approved for use in DEFUSE 3: Trevo Retriever; Solitaire™ FR Revascularization Device; Penumbra thrombectomy system; Covidien MindFrame Capture Revascularization Device	Procedure: Endovascular Thrombectomy; Patients will be treated with thrombectomy devices (stent-retrievers) and/or suction thrombectomy systems currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke following the published instructions for use for these devices. These devices will be used between 6 and 16 hours following symptom onset in DEFUSE 3 based on an FDA IDE. The devices which will be used are the Trevo Retriever, the Solitaire Revascularization Device and the Penumbra system thrombectomy system.; Device: Trevo Retriever; Trevo Retriever is one of the interventional devices that is approved for use in DEFUSE 3 during the endovascular thrombectomy procedure. The device choice is at the discretion of the physician performing the procedure.; Device: Solitaire™ FR Revascularization Device; Solitaire™ FR Revascularization Device is one of the interventional devices that is approved for use in DEFUSE 3 during the endovascular thrombectomy procedure. The device choice is at the discretion of the physician performing the procedure.; Device: Penumbra thrombectomy system; Penumbra thrombectomy system is one of the interventional devices that is approved for use in DEFUSE 3 during the endovascular thrombectomy procedure. The device choice is at the discretion of the physician performing the procedure. The Penumbra System includes: • Penumbra Aspiration Pump (1115V) Penumbra System 054 Penumbra System MAX Penumbra System 110 Aspiration Tubing Penumbra System [026, 032, 041] Penumbra System Separator Flex [026, 032, 041, 054] Penumbra Pump MAX Penumbra System Reperfusion Catheter ACE64 & ACE68; Device: Covidien MindFrame Capture Revascularization Device; Covidien MindFrame Capture Revascularization Device is one of the interventional devices that is approved for use in DEFUSE 3 during the endovascular thrombectomy procedure. The device choice is at the discretion of the physician performing the procedure.
No Intervention: Medical Management; standard medical therapy alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90	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. 0 - No symptoms.; - No significant disability. Able to carry out all usual activities, despite some symptoms.; - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; - Moderate disability. Requires some help, but able to walk unassisted.; - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; - Dead.	Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Count of Patients With mRS 0-2 at Day 90 as a Measure of Functional Independence	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. 0 - No symptoms.; No significant disability. Able to carry out all usual activities, despite some symptoms.; Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; Moderate disability. Requires some help, but able to walk unassisted.; Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; Dead.	day 90

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Count of Participants With Symptomatic Intracranial Hemorrhage (Primary Safety Outcome)	Defined as NIHSS worsening of 4 or more points associated with brain hemorrhage within 36 hours of randomization	36 hours
Parenchymal Hematoma Type 2 (Safety Outcome)	PH 2 rates on the 24 hour scan (±6)	24 (±6) hours
Infarct Volume (Imaging Outcome)	Infarct volume on diffusion-weighted MRI (or CT if MRI not feasible) at 24 (±6) hours after randomization	24 (+/- 6) hours
Lesion Growth (Imaging Outcome)	Lesion growth between the RAPID-identified ischemic core on baseline imaging and the infarct volume at 24 hours (±6)	24 hours (±6)
Reperfusion (Imaging Outcome)	Successful reperfusion defined as a >90% reduction in Tmax>6sec lesion volume between baseline and 24 hours	between baseline and 24 hours (+/- 6 hours)
Recanalization (Imaging Outcome)	Recanalization of the primary arterial occlusive lesion at 24-hours on CTA/MRA	24 hours (±6)

Collaborators and Investigators

• Sponsor: Gregory W Albers
• Collaborators: Medical University of South Carolina; National Institute of Neurological Disorders and Stroke (NINDS); University of Cincinnati; NINDS Stroke Trials Network (StrokeNet)
• Investigators: Principal Investigator: Gregory Albers, MD, Stanford University; Principal Investigator: Michael Marks, MD, Stanford University; Principal Investigator: Maarten Lansberg, MD, PhD, Stanford University

Publications and helpful links

General Publications

• Albers GW, Marks MP, Kemp S, Christensen S, Tsai JP, Ortega-Gutierrez S, McTaggart RA, Torbey MT, Kim-Tenser M, Leslie-Mazwi T, Sarraj A, Kasner SE, Ansari SA, Yeatts SD, Hamilton S, Mlynash M, Heit JJ, Zaharchuk G, Kim S, Carrozzella J, Palesch YY, Demchuk AM, Bammer R, Lavori PW, Broderick JP, Lansberg MG; DEFUSE 3 Investigators. Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging. N Engl J Med. 2018 Feb 22;378(8):708-718. doi: 10.1056/NEJMoa1713973. Epub 2018 Jan 24.
• Albers GW, Lansberg MG, Kemp S, Tsai JP, Lavori P, Christensen S, Mlynash M, Kim S, Hamilton S, Yeatts SD, Palesch Y, Bammer R, Broderick J, Marks MP. A multicenter randomized controlled trial of endovascular therapy following imaging evaluation for ischemic stroke (DEFUSE 3). Int J Stroke. 2017 Oct;12(8):896-905. doi: 10.1177/1747493017701147. Epub 2017 Mar 24.
• Marks MP, Heit JJ, Lansberg MG, Kemp S, Christensen S, Derdeyn CP, Rasmussen PA, Zaidat OO, Broderick JP, Yeatts SD, Hamilton S, Mlynash M, Albers GW; DEFUSE 3 Investigators. Endovascular Treatment in the DEFUSE 3 Study. Stroke. 2018 Aug;49(8):2000-2003. doi: 10.1161/STROKEAHA.118.022147.
• Tate WJ, Polding LC, Christensen S, Mlynash M, Kemp S, Heit JJ, Marks MP, Albers GW, Lansberg MG. Predictors of Early and Late Infarct Growth in DEFUSE 3. Front Neurol. 2021 Jul 1;12:699153. doi: 10.3389/fneur.2021.699153. eCollection 2021.
• Polding LC, Tate WJ, Mlynash M, Marks MP, Heit JJ, Christensen S, Kemp S, Albers GW, Lansberg MG; DEFUSE 3 Investigators. Quality of Life in Physical, Social, and Cognitive Domains Improves With Endovascular Therapy in the DEFUSE 3 Trial. Stroke. 2021 Apr;52(4):1185-1191. doi: 10.1161/STROKEAHA.120.031490. Epub 2021 Feb 18.
• Sarraj A, Mlynash M, Heit J, Pujara D, Lansberg M, Marks M, Albers GW. Clinical Outcomes and Identification of Patients With Persistent Penumbral Profiles Beyond 24 Hours From Last Known Well: Analysis From DEFUSE 3. Stroke. 2021 Mar;52(3):838-849. doi: 10.1161/STROKEAHA.120.031147. Epub 2021 Feb 10.
• Cereda CW, Mlynash M, Cippa PE, Kemp S, Heit JJ, Marks MP, Lansberg MG, Albers GW. Renal Safety of Multimodal Brain Imaging Followed by Endovascular Therapy. Stroke. 2021 Jan;52(1):313-316. doi: 10.1161/STROKEAHA.120.030816. Epub 2020 Nov 30.
• Heit JJ, Mlynash M, Christensen S, Kemp SM, Lansberg MG, Marks MP, Olivot JM, Gregory AW. What predicts poor outcome after successful thrombectomy in late time windows? J Neurointerv Surg. 2021 May;13(5):421-425. doi: 10.1136/neurintsurg-2020-016125. Epub 2020 Jun 17.
• Kim-Tenser M, Mlynash M, Lansberg MG, Tenser M, Bulic S, Jagadeesan B, Christensen S, Simpkins A, Albers GW, Marks MP, Heit JJ. CT perfusion core and ASPECT score prediction of outcomes in DEFUSE 3. Int J Stroke. 2021 Apr;16(3):288-294. doi: 10.1177/1747493020915141. Epub 2020 Mar 31. Erratum In: Int J Stroke. 2020 Apr 29;:1747493020922800.
• Dula AN, Mlynash M, Zuck ND, Albers GW, Warach SJ; DEFUSE 3 Investigators. Neuroimaging in Ischemic Stroke Is Different Between Men and Women in the DEFUSE 3 Cohort. Stroke. 2020 Feb;51(2):481-488. doi: 10.1161/STROKEAHA.119.028205. Epub 2019 Dec 12.
• Amukotuwa SA, Fischbein NJ, Albers GW, Davis S, Donnan GA, Andre JB, Bammer R. Comparison of T2*GRE and DSC-PWI for hemorrhage detection in acute ischemic stroke patients: Pooled analysis of the EPITHET, DEFUSE 2, and SENSE 3 stroke studies. Int J Stroke. 2020 Feb;15(2):216-225. doi: 10.1177/1747493019858781. Epub 2019 Jul 10.
• Tate WJ, Polding LC, Kemp S, Mlynash M, Heit JJ, Marks MP, Albers GW, Lansberg MG. Thrombectomy Results in Reduced Hospital Stay, More Home-Time, and More Favorable Living Situations in DEFUSE 3. Stroke. 2019 Sep;50(9):2578-2581. doi: 10.1161/STROKEAHA.119.025165. Epub 2019 Jul 10.
• Heit JJ, Mlynash M, Kemp SM, Lansberg MG, Christensen S, Marks MP, Ortega-Gutierrez S, Albers GW. Rapid Neurologic Improvement Predicts Favorable Outcome 90 Days After Thrombectomy in the DEFUSE 3 Study. Stroke. 2019 May;50(5):1172-1177. doi: 10.1161/STROKEAHA.119.024928.
• Christensen S, Mlynash M, Kemp S, Yennu A, Heit JJ, Marks MP, Lansberg MG, Albers GW. Persistent Target Mismatch Profile >24 Hours After Stroke Onset in DEFUSE 3. Stroke. 2019 Mar;50(3):754-757. doi: 10.1161/STROKEAHA.118.023392.
• Sarraj A, Mlynash M, Savitz SI, Heit JJ, Lansberg MG, Marks MP, Albers GW. Outcomes of Thrombectomy in Transferred Patients With Ischemic Stroke in the Late Window: A Subanalysis From the DEFUSE 3 Trial. JAMA Neurol. 2019 Jun 1;76(6):682-689. doi: 10.1001/jamaneurol.2019.0118.
• Rao V, Christensen S, Yennu A, Mlynash M, Zaharchuk G, Heit J, Marks MP, Lansberg MG, Albers GW. Ischemic Core and Hypoperfusion Volumes Correlate With Infarct Size 24 Hours After Randomization in DEFUSE 3. Stroke. 2019 Mar;50(3):626-631. doi: 10.1161/STROKEAHA.118.023177.
• de Havenon A, Mlynash M, Kim-Tenser MA, Lansberg MG, Leslie-Mazwi T, Christensen S, McTaggart RA, Alexander M, Albers G, Broderick J, Marks MP, Heit JJ; DEFUSE 3 Investigators. Results From DEFUSE 3: Good Collaterals Are Associated With Reduced Ischemic Core Growth but Not Neurologic Outcome. Stroke. 2019 Mar;50(3):632-638. doi: 10.1161/STROKEAHA.118.023407.
• Lansberg MG, Mlynash M, Hamilton S, Yeatts SD, Christensen S, Kemp S, Lavori PW, Ortega-Gutierrez S, Broderick J, Heit J, Marks MP, Albers GW; DEFUSE 3 Investigators. Association of Thrombectomy With Stroke Outcomes Among Patient Subgroups: Secondary Analyses of the DEFUSE 3 Randomized Clinical Trial. JAMA Neurol. 2019 Apr 1;76(4):447-453. doi: 10.1001/jamaneurol.2018.4587.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): August 23, 2017
• Study Completion (Actual): August 23, 2017

Study Registration Dates

• First Submitted: October 21, 2015
• First Submitted That Met QC Criteria: October 22, 2015
• First Posted (Estimate): October 26, 2015

Study Record Updates

• Last Update Posted (Actual): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: endovascular; Mechanical Thrombectomy; endovascular procedure
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Brain Infarction; Infarction; Stroke; Ischemic Stroke; Cerebral Infarction
• Other Study ID Numbers: 116661; U10NS086487 (U.S. NIH Grant/Contract); U01NS092076 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No