Diffusion Weighted Imaging Evaluation for Understanding Stroke Evolution Study-2 (DEFUSE-2)
3 other identifiers
observational
138
1 country
7
Brief Summary
Diffusion and Perfusion Imaging Evaluation for Understanding Stroke Evolution Study 2 (DEFUSE 2) is a multi-center pilot study to determine if cerebral perfusion imaging can help identify which patients, who are ineligible for intravenous tissue plasminogen activator (iv tPA) therapy or have failed iv tPA therapy, are most likely to benefit from an endovascular clot removal procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2008
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 5, 2011
CompletedFirst Posted
Study publicly available on registry
May 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedApril 14, 2016
April 1, 2016
3.3 years
May 5, 2011
April 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
NIHSS Score
30 days
Secondary Outcomes (1)
Modifies Rankin Score
90 days
Eligibility Criteria
population includes those people with acute ischemic stroke
You may qualify if:
- Age 18 years and older
- Clinical diagnosis of ischemic stroke and a score of 5 or more points in the NIHSS.
- Planned to undergo intra-arterial (IA) therapy for acute hemispheric stroke (Either as primary therapy or as adjuvant therapy following intravenous tPA treatment)
- Planned to have a standard MRI including perfusion imaging and MR angiography of the circle of Willis (MRA) prior to IA therapy
- Intra-arterial thrombectomy can be started within 90 minutes of completion of MRI scan and within 12 hours of symptom onset. (Start of IA therapy is defined as the time of insertion of the femoral artery sheath; Time of brain scan is defined as the time that the scan is completed)
- Able to obtain informed consent (informed consent should be obtained prior to the baseline MRI scan).
You may not qualify if:
- Any pre-existing neurological illness resulting in a modified Rankin Scale Score of 3 or higher prior to the qualifying stroke
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- University of Pittsburghcollaborator
- Northwestern Universitycollaborator
- University of Utahcollaborator
- Oregon Health and Science Universitycollaborator
- St. Luke's Medical Centercollaborator
- Queen's Medical Centercollaborator
- Swedish Health Servicescollaborator
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
Study Sites (7)
Stanford University School of Medicine
Stanford, California, 94305, United States
The Queen
Honolulu, Hawaii, United States
Northwestern University
Chicago, Illinois, United States
Oregon Health Sciences University
Portland, Oregon, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States
Swedish Hospital
Seattle, Washington, United States
Related Publications (3)
Lansberg MG, Straka M, Kemp S, Mlynash M, Wechsler LR, Jovin TG, Wilder MJ, Lutsep HL, Czartoski TJ, Bernstein RA, Chang CW, Warach S, Fazekas F, Inoue M, Tipirneni A, Hamilton SA, Zaharchuk G, Marks MP, Bammer R, Albers GW; DEFUSE 2 study investigators. MRI profile and response to endovascular reperfusion after stroke (DEFUSE 2): a prospective cohort study. Lancet Neurol. 2012 Oct;11(10):860-7. doi: 10.1016/S1474-4422(12)70203-X. Epub 2012 Sep 4.
PMID: 22954705RESULTYu Y, Christensen S, Ouyang J, Scalzo F, Liebeskind DS, Lansberg MG, Albers GW, Zaharchuk G. Predicting Hypoperfusion Lesion and Target Mismatch in Stroke from Diffusion-weighted MRI Using Deep Learning. Radiology. 2023 Apr;307(1):e220882. doi: 10.1148/radiol.220882. Epub 2022 Dec 6.
PMID: 36472536DERIVEDMarks MP, Lansberg MG, Mlynash M, Olivot JM, Straka M, Kemp S, McTaggart R, Inoue M, Zaharchuk G, Bammer R, Albers GW; Diffusion and Perfusion Imaging Evaluation for Understanding Stroke Evolution 2 Investigators. Effect of collateral blood flow on patients undergoing endovascular therapy for acute ischemic stroke. Stroke. 2014 Apr;45(4):1035-9. doi: 10.1161/STROKEAHA.113.004085. Epub 2014 Feb 25.
PMID: 24569816DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory W Albers
Stanford University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Professor of Neurology
Study Record Dates
First Submitted
May 5, 2011
First Posted
May 9, 2011
Study Start
June 1, 2008
Primary Completion
September 1, 2011
Study Completion
December 1, 2011
Last Updated
April 14, 2016
Record last verified: 2016-04