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TerminatedNCT02586415DEFUSE 3Updated May 21, 2019Results posted

Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3

An interventional study of Endovascular Thrombectomy and Trevo Retriever in Stroke, Acute and Cerebral Infarction, sponsored by Gregory W Albers. Terminated at 40 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-05-21.

Sponsored by Gregory W Albers · Not applicable, Interventional, and Treatment

Why this study was terminated
Interim analysis showed a high likelihood of benefit in the endovascular group
Phase
Not applicable
Study type
Interventional
Enrollment
182
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Stroke, Acute
  • Cerebral Infarction

Keywords

  • endovascular
  • endovascular procedure
  • Mechanical Thrombectomy
03

In context

Stroke

7,287 studies on the registry are indexed under Stroke; 2,006 are open to participants now.

This study's enrollment of 182 is above the median of 50 across 5,370 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

This is the only study on the registry with Gregory W Albers as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
182 participants (actual)

Study arms

  • 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 · Device: Trevo Retriever · Device: Solitaire™ FR Revascularization Device · Device: Penumbra thrombectomy system · Device: Covidien MindFrame Capture Revascularization Device

  • No intervention
    Medical Management

    standard medical therapy alone

Interventions

  • ProcedureEndovascular 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.

  • DeviceTrevo 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.

  • DeviceSolitaire™ 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.

  • DevicePenumbra 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

  • DeviceCovidien 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.

06

What researchers measure

Primary outcomes

  1. 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. 1. - No significant disability. Able to carry out all usual activities, despite some symptoms. 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. - Dead.

    Time frame: Day 90

Secondary outcomes

  1. 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.

    Time frame: day 90

Other outcomes

  1. 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

    Time frame: 36 hours

  2. Parenchymal Hematoma Type 2 (Safety Outcome)

    PH 2 rates on the 24 hour scan (±6)

    Time frame: 24 (±6) hours

  3. Infarct Volume (Imaging Outcome)

    Infarct volume on diffusion-weighted MRI (or CT if MRI not feasible) at 24 (±6) hours after randomization

    Time frame: 24 (+/- 6) hours

  4. Lesion Growth (Imaging Outcome)

    Lesion growth between the RAPID-identified ischemic core on baseline imaging and the infarct volume at 24 hours (±6)

    Time frame: 24 hours (±6)

  5. Reperfusion (Imaging Outcome)

    Successful reperfusion defined as a \>90% reduction in Tmax\>6sec lesion volume between baseline and 24 hours

    Time frame: between baseline and 24 hours (+/- 6 hours)

  6. Recanalization (Imaging Outcome)

    Recanalization of the primary arterial occlusive lesion at 24-hours on CTA/MRA

    Time frame: 24 hours (±6)

07

Results

Posted Sep 19, 2018

Participant flow

From May 2016 through May 2017, a total of 182 patients underwent randomization (92 to the endovascular-therapy group and 90 to the medical-therapy group) at 38 centers in the United States.

Participant flow — Overall Study
MilestoneEndovascular Thrombectomy TherapyMedical Management
Started9290
24 hour assessment9190
Day 30 assessment8170
Day 90 assessment7865
Completed7865
Not completed1425
Withdrew: Death1323
Withdrew: Lost to follow-up12

Outcome measures

PrimaryThe 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. 1. - No significant disability. Able to carry out all usual activities, despite some symptoms. 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. - Dead.

Time frame:
Day 90
Reported as:
Median · score on a scale
The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90
score on a scaleEndovascular Thrombectomy TherapyMedical Management
The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 903 (1 to 4)4 (3 to 6)
Statistical analysis
  • Endovascular Thrombectomy Therapy vs Medical Management · Cochran-Mantel-Haenszel · p = <0.001 (Criteria to assess superiority was a two-sided P value of \<0.05. The study was terminated early because the pre-specified stopping boundary of P \<0.0025 was crossed at the first interim analysis (N=182)) · Odds ratio (or): 2.77 · 95% CI 1.63 to 4.70
SecondaryCount 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.

Time frame:
day 90
Reported as:
Count of participants · Participants
Count of Patients With mRS 0-2 at Day 90 as a Measure of Functional Independence
ParticipantsEndovascular Thrombectomy TherapyMedical Management
Count of Patients With mRS 0-2 at Day 90 as a Measure of Functional Independence4115
Other pre-specifiedCount 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

Time frame:
36 hours
Reported as:
Count of participants · Participants
Count of Participants With Symptomatic Intracranial Hemorrhage (Primary Safety Outcome)
ParticipantsEndovascular Thrombectomy TherapyMedical Management
Count of Participants With Symptomatic Intracranial Hemorrhage (Primary Safety Outcome)64
Other pre-specifiedParenchymal Hematoma Type 2 (Safety Outcome)

PH 2 rates on the 24 hour scan (±6)

Time frame:
24 (±6) hours

Results for this outcome have not been posted.

Other pre-specifiedInfarct Volume (Imaging Outcome)

Infarct volume on diffusion-weighted MRI (or CT if MRI not feasible) at 24 (±6) hours after randomization

Time frame:
24 (+/- 6) hours

Results for this outcome have not been posted.

Other pre-specifiedLesion Growth (Imaging Outcome)

Lesion growth between the RAPID-identified ischemic core on baseline imaging and the infarct volume at 24 hours (±6)

Time frame:
24 hours (±6)

Results for this outcome have not been posted.

Other pre-specifiedReperfusion (Imaging Outcome)

Successful reperfusion defined as a \>90% reduction in Tmax\>6sec lesion volume between baseline and 24 hours

Time frame:
between baseline and 24 hours (+/- 6 hours)

Results for this outcome have not been posted.

Other pre-specifiedRecanalization (Imaging Outcome)

Recanalization of the primary arterial occlusive lesion at 24-hours on CTA/MRA

Time frame:
24 hours (±6)

Results for this outcome have not been posted.

Adverse events

Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Endovascular Thrombectomy Therapy13/92 (14.1%)40/92 (43.5%)57/92 (62%)
Medical Management23/90 (25.6%)48/90 (53.3%)59/90 (65.6%)
Most frequent serious events
Showing 10 of 59
Most frequent serious events
EventEndovascular Thrombectomy TherapyMedical Management
Stroke in evolutionNervous system disorders3/929/90
Cerebrovascular accidentNervous system disorders2/925/90
Pneumonia aspirationRespiratory, thoracic and mediastinal disorders3/925/90
SepsisInfections and infestations1/924/90
Brain oedemaNervous system disorders4/923/90
Haemorrhagic transformation strokeNervous system disorders3/923/90
Neurological decompensationNervous system disorders2/923/90
Pulmonary embolismRespiratory, thoracic and mediastinal disorders1/923/90
Acute respiratory failureRespiratory, thoracic and mediastinal disorders1/922/90
Atrial fibrillationCardiac disorders1/922/90
Most frequent other events
Showing 10 of 118
Most frequent other events
EventEndovascular Thrombectomy TherapyMedical Management
Haemorrhagic transformation strokeNervous system disorders15/9210/90
Urinary tract infectionInfections and infestations4/9210/90
PyrexiaGeneral disorders7/924/90
Atrial fibrillationCardiac disorders6/925/90
HypokalaemiaMetabolism and nutrition disorders3/925/90
HypotensionVascular disorders5/925/90
Neurological decompensationNervous system disorders0/925/90
Pneumonia aspirationRespiratory, thoracic and mediastinal disorders4/925/90
Haemorrhage intracranialNervous system disorders5/921/90
HeadacheNervous system disorders5/924/90

Baseline characteristics

Age, Continuous
Age, Continuous(years)Endovascular Thrombectomy TherapyMedical ManagementTotal
Median70 (59 to 78.5)71 (59 to 80)70.5 (59 to 80)
Sex: Female, Male
Sex: Female, Male(Participants)Endovascular Thrombectomy TherapyMedical ManagementTotal
Female464692
Male464490
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Endovascular Thrombectomy TherapyMedical ManagementTotal
Hispanic or Latino141024
Not Hispanic or Latino7780157
Unknown or Not Reported101
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Endovascular Thrombectomy TherapyMedical ManagementTotal
American Indian or Alaska Native011
Asian336
Native Hawaiian or Other Pacific Islander000
Black or African American10515
White7880158
More than one race000
Unknown or Not Reported112
NIHSS, continuous
NIHSS, continuous(units on a scale)Endovascular Thrombectomy TherapyMedical ManagementTotal
Median16 (10 to 20)16 (12 to 21)16 (11 to 21)
08

Study locations

40 sites
  • University of Alabama
    Birmingham, Alabama 35233-1932, United States
  • Community Regional Medical Center
    Fresno, California 93721-1324, United States
  • Scripps Memorial Hospital
    La Jolla, California 92037-1205, United States
  • UCSD Medical Center/Hillcrest Hospital
    La Jolla, California 92093, United States
  • Keck Hospital of University of Southern California
    Los Angeles, California 90033-5313, United States
  • UCSF Medical Center, San Francisco, CA
    San Francisco, California 94110-3518, United States
  • Stanford University
    Stanford, California 94305, United States
  • John Muir Medical Center
    Walnut Creek, California 94598-3122, United States
  • MedStar Washington Hospital Center
    Washington, District of Columbia 20010-3017, United States
  • Northwestern Memorial Hospital
    Chicago, Illinois 60611-2908, United States
  • University of Iowa Hospital and Clinics
    Iowa City, Iowa 52242-1009, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114-2621, United States
  • The Brigham and Women's Hospital
    Boston, Massachusetts 02115-6110, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215-5400, United States
  • University of Michigan Hospital
    Ann Arbor, Michigan 48109-5000, United States
  • Abbott Northwestern Hospital
    Minneapolis, Minnesota 55407-3723, United States
  • Hennepin County Medical Center
    Minneapolis, Minnesota 55415-1623, United States
  • University of Minnesota Medical Center, Fairview
    Minneapolis, Minnesota 55455-0363, United States
  • The Valley Hospital
    Ridgewood, New Jersey 07450, United States
  • Mount Sinai Hospital
    New York, New York 10029-6504, United States
  • New York Presbyterian Hospital at Columbia
    New York, New York 10032-3725, United States
  • NYP Weill Cornell Medical Center
    New York, New York 10065-4870, United States
  • University of Cincinnati
    Cincinnati, Ohio 45221-0222, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195-0001, United States
  • Ohio State University Wexner Medical Center
    Columbus, Ohio 43210-1280, United States
  • Mercy Health St. Vincent Medical Center
    Toledo, Ohio 43608-2603, United States
  • Providence St. Vincent Medical Center
    Portland, Oregon 97225-6603, United States
  • Oregon Health & Science University Hospital
    Portland, Oregon 97239-3098, United States
  • Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104-4238, United States
  • Temple University Hospital
    Philadelphia, Pennsylvania 19140-5103, United States
  • Rhode Island Hospital
    Providence, Rhode Island 02903-4923, United States
  • Palmetto Health Richland
    Columbia, South Carolina 29203-6863, United States
  • Vanderbilt University
    Nashville, Tennessee 37240-0001, United States
  • University Medical Center Brackenridge
    Austin, Texas 78701-1930, United States
  • Seton Medical Center/UT Southwestern
    Austin, Texas 78705-1006, United States
  • Memorial Hermann Texas Medical Center
    Houston, Texas 77030-5401, United States
  • Intermountain Medical Center
    Salt Lake City, Utah 84111-1470, United States
  • University of Utah Healthcare
    Salt Lake City, Utah 84112-9023, United States
  • Harborview Medical Center
    Seattle, Washington 98104-2420, United States
  • University of Wisconsin
    Madison, Wisconsin 53715-1218, United States
09

References and documents

Publications

  • 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. PubMed 28946832 ↗
  • 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. PubMed 29364767 ↗
  • 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. PubMed 29986935 ↗
  • 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. PubMed 34276547 ↗
  • 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. PubMed 33596675 ↗
  • 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. PubMed 33563012 ↗
  • 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. PubMed 33250038 ↗
  • 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. PubMed 32554693 ↗
  • 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 Dec;15(9):NP15. doi: 10.1177/1747493020922800. PubMed 32233746 ↗
  • 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. PubMed 31826731 ↗
  • 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. PubMed 31291850 ↗
  • 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. PubMed 31288666 ↗
  • 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. PubMed 30932783 ↗
  • 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. PubMed 30735466 ↗
  • 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. PubMed 30734042 ↗
  • 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. PubMed 30727840 ↗
  • 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. PubMed 30726184 ↗
  • 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. PubMed 30688974 ↗

Study documents

  • Statistical analysis plan · Sep 8, 2017
  • Study protocol · Apr 20, 2017

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02586415
Lead sponsor
Gregory W Albers
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), University of Cincinnati, Medical University of South Carolina, NINDS Stroke Trials Network (StrokeNet)
Responsible party
Gregory W Albers (Professor of Neurology, Stanford University) — Sponsor-investigator
First posted
Oct 26, 2015
Start date
Apr 2016
Primary completion
Aug 23, 2017
Completion
Aug 23, 2017
Results posted
Sep 19, 2018
Last update
May 21, 2019

Study contacts

Gregory Albers, MD
principal investigator · Stanford University
Michael Marks, MD
principal investigator · Stanford University
Maarten Lansberg, MD, PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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