SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study
NCT ID: NCT01054560
Last Updated: 2016-10-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
144 participants
INTERVENTIONAL
2010-01-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SOLITAIRE™ Device
The SOLITAIRE™ Device (investigational device) is the experimental arm
SOLITAIRE™ Device
The SOLITAIRE™ Device is the experimental device that will be used in the interventional procedure
MERCI® Device
The MERCI® Device (control device) is commercially available.
MERCI® Device
The MERCI® Device is the control device that will be used in the interventional procedure.
Interventions
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SOLITAIRE™ Device
The SOLITAIRE™ Device is the experimental device that will be used in the interventional procedure
MERCI® Device
The MERCI® Device is the control device that will be used in the interventional procedure.
Eligibility Criteria
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Inclusion Criteria
* Age22-85
* Clinical signs consistent with acute ischemic stroke
* National Institutes of Health Stroke Scale (NIHSS) ≥8and\<30
* Thrombolysis in Myocardial Infarction (TIMI) 0 or TIMI 1 flow in the M1 or M2 of middle cerebral artery, internal carotid artery, basilar or vertebral arteries confirmed by angiography that is accessible to the SOLITAIRETM or MERCI® Device
* Patient is able to be treated within 8 hours of stroke symptoms onset with minimum of one deployment of the SOLITAIRETM or MERCI® Device.
* Patient who is ineligible or failed intravenous tissue plasminogen activator (t-PA) therapy given at local institutions or within national practice.
* Patient is willing to conduct follow-up visits
Exclusion Criteria
* Neurological signs that are rapidly improving prior to or at time of treatment
* Females who are pregnant or lactating
* Known serious sensitivity to radiographic contrast agents
* Current participation in another investigation drug or device study
* Uncontrolled hypertension defined as systolic blood pressure \> 185 or diastolic blood pressure \> 110 that cannot be controlled except with continuous parenteral antihypertensive medication
* Use of warfarin anticoagulation with International Normalized Ratio (INR) \> 3.0
* Platelet count \< 30,000
* Glucose \< 50 mg/dL
* Arterial tortuosity that would prevent the device from reaching the target vessel
* Life expectancy of less than 90 days
* Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of hemorrhage on presentation
* CT showing hypodensity or MR showing hyperintensity involving greater than 1/3 of the middle cerebral artery (MCA) territory (or in other territories, \>100 cc of tissue) on presentation
* CT or MRI evidence of mass effect or intracranial tumor (except small meningioma)
* Angiographic evidence of carotid dissection, complete cervical carotid occlusions, or vasculitis
22 Years
85 Years
ALL
No
Sponsors
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Medtronic Neurovascular Clinical Affairs
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffrey L. Saver, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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Oregon Stroke Center
Portland, Oregon, United States
Multicare Health System
Tacoma, Washington, United States
Countries
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References
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Raychev R, Saver JL, Jahan R, Nogueira RG, Goyal M, Pereira VM, Gralla J, Levy EI, Yavagal DR, Cognard C, Liebeskind DS. The impact of general anesthesia, baseline ASPECTS, time to treatment, and IV tPA on intracranial hemorrhage after neurothrombectomy: pooled analysis of the SWIFT PRIME, SWIFT, and STAR trials. J Neurointerv Surg. 2020 Jan;12(1):2-6. doi: 10.1136/neurintsurg-2019-014898. Epub 2019 Jun 25.
Coutinho JM, Liebeskind DS, Slater LA, Nogueira RG, Clark W, Davalos A, Bonafe A, Jahan R, Fischer U, Gralla J, Saver JL, Pereira VM. Combined Intravenous Thrombolysis and Thrombectomy vs Thrombectomy Alone for Acute Ischemic Stroke: A Pooled Analysis of the SWIFT and STAR Studies. JAMA Neurol. 2017 Mar 1;74(3):268-274. doi: 10.1001/jamaneurol.2016.5374.
Kim JT, Jahan R, Saver JL; SWIFT Investigators. Impact of Glucose on Outcomes in Patients Treated With Mechanical Thrombectomy: A Post Hoc Analysis of the Solitaire Flow Restoration With the Intention for Thrombectomy Study. Stroke. 2016 Jan;47(1):120-7. doi: 10.1161/STROKEAHA.115.010753. Epub 2015 Dec 10.
Sheth SA, Jahan R, Levy EI, Jovin TG, Baxter B, Nogueira RG, Clark W, Budzik R, Zaidat OO, Saver JL; SWIFT Trialists. Rapid learning curve for Solitaire FR stent retriever therapy: evidence from roll-in and randomised patients in the SWIFT trial. J Neurointerv Surg. 2016 Apr;8(4):347-52. doi: 10.1136/neurintsurg-2014-011627. Epub 2015 Feb 12.
Liebeskind DS, Jahan R, Nogueira RG, Zaidat OO, Saver JL; SWIFT Investigators. Impact of collaterals on successful revascularization in Solitaire FR with the intention for thrombectomy. Stroke. 2014 Jul;45(7):2036-40. doi: 10.1161/STROKEAHA.114.004781. Epub 2014 May 29.
Liebeskind DS, Jahan R, Nogueira RG, Jovin TG, Lutsep HL, Saver JL; SWIFT Investigators. Serial Alberta Stroke Program early CT score from baseline to 24 hours in Solitaire Flow Restoration with the Intention for Thrombectomy study: a novel surrogate end point for revascularization in acute stroke. Stroke. 2014 Mar;45(3):723-7. doi: 10.1161/STROKEAHA.113.003914. Epub 2014 Feb 13.
Saver JL, Jahan R, Levy EI, Jovin TG, Baxter B, Nogueira RG, Clark W, Budzik R, Zaidat OO; SWIFT Trialists. Solitaire flow restoration device versus the Merci Retriever in patients with acute ischaemic stroke (SWIFT): a randomised, parallel-group, non-inferiority trial. Lancet. 2012 Oct 6;380(9849):1241-9. doi: 10.1016/S0140-6736(12)61384-1. Epub 2012 Aug 26.
Related Links
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American Heart Association - Stroke
ev3, Inc.
Other Identifiers
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SWIFT
Identifier Type: -
Identifier Source: org_study_id