SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study (SWIFT)

• ClinicalTrials.gov Identifier: NCT01054560
• Recruitment Status: Completed
• First Posted: January 22, 2010
• Results First Posted: October 26, 2016
• Last Update Posted: October 26, 2016
• Sponsor: Medtronic Neurovascular Clinical Affairs
• Information provided by (Responsible Party): Medtronic Neurovascular Clinical Affairs

Tracking Information

• First Submitted Date: December 10, 2009
• First Posted Date: January 22, 2010
• Results First Submitted Date: April 24, 2012
• Results First Posted Date: October 26, 2016
• Last Update Posted Date: October 26, 2016
• Study Start Date: January 2010
• Actual Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 31, 2016)

• Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage [ Time Frame: Immediately post treatment ]
  Successful arterial recanalization of occluded target vessel measured by Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following the use of the SOLITAIRE™ or MERCI® Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes. Thrombolysis in Myocardial Infarction (TIMI) score describes the distal flow perfusion and revascularization before and following therapy. TIMI 0 - No perfusion (worst outcome) TIMI 1 - Perfusion past the initial occlusion, but no distal branch filling TIMI 2 - Perfusion with incomplete or slow distal branch filling TIMI 3 - Full perfusion with filling of all distal branches (best outcome)
• Study Device-related Serious Adverse Events (SAEs) [ Time Frame: 90 Day ]
  Incidence of study device-related Serious Adverse Events (SAEs)
• Procedure-related Serious Adverse Events (SAEs) [ Time Frame: 90 Day ]
  Incidence of study procedure-related Serious Adverse Events (SAEs)

• Original Primary Outcome Measures (submitted: January 20, 2010): Arterial recanalization of occluded target vessel measured by Thrombolysis in Myocardial Infarction (TIMI)score of 2 or 3 following the use of the SOLITAIRE™ or MERCI® Device without any symptomatic intracranial hemorrhage. [ Time Frame: Immediately post treatment ]

Current Secondary Outcome Measures (submitted: August 31, 2016)

• Time to Initial Recanalization [ Time Frame: post treatment ]
  Time from guide catheter placement to first visualization of Thrombolysis in Myocardial Infarction (TIMI) 2 flow
• Good Neurological Outcome at 30 Days [ Time Frame: 30 Days Follow-up ]
  Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more
• Good Neurological Outcome 90 Days [ Time Frame: 90 Days Follow-up ]
  Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more
• Mortality [ Time Frame: 90 Days follow-up ]
  Rate of Mortality
• Symptomatic Intracranial Hemorrhage [ Time Frame: 24 hours ]
  Symptomatic hemorrhage within 24 hours of procedure. Symptomatic hemorrhages is defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a worsening of National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24hrs.
• Non-fatal Stroke-related Morbidity [ Time Frame: 90 Day ]
  Morbidity data is presented in terms of subjects with permanent deficit as a result of one or more adverse events

• Original Secondary Outcome Measures (submitted: January 20, 2010): Time to initial recanalization Measurement of patient's neurological condition including NIH Stroke Scale, Barthel Index and Modified Rankin Score at 30 and 90 days post procedure Rate of morbidity and mortality Incidence of symptomatic hemorrhage [ Time Frame: 30 and 90 days post treatment ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study
• Official Title: SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study
• Brief Summary: The purpose of this study is to demonstrate substantial equivalence of the SOLITAIRE™ FR Revascularization Device (SOLITAIRE™ Device) with a legally marketed device, MERCI Retrieval System® (MERCI® Device). The study will demonstrate safety and efficacy of the SOLITAIRE™ Device in subjects requiring mechanical thrombectomy diagnosed with acute ischemic stroke.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Ischemic Stroke

Intervention

• Device: SOLITAIRE™ Device
  The SOLITAIRE™ Device is the experimental device that will be used in the interventional procedure
• Device: MERCI® Device
  The MERCI® Device is the control device that will be used in the interventional procedure.

Study Arms

• Experimental: SOLITAIRE™ Device
  The SOLITAIRE™ Device (investigational device) is the experimental arm
  Intervention: Device: SOLITAIRE™ Device
• Active Comparator: MERCI® Device
  The MERCI® Device (control device) is commercially available.
  Intervention: Device: MERCI® Device

Publications *

• 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. Erratum In: J Neurointerv Surg. 2021 Sep;13(9):e21.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 31, 2016): 144
• Original Estimated Enrollment (submitted: January 20, 2010): 200
• Actual Study Completion Date: July 2011
• Actual Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patient or patient's legally authorized representative has signed and dated an Informed Consent Form
• 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:

• NIHSS > 30 or coma
• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 22 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01054560
• Other Study ID Numbers: SWIFT
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Medtronic Neurovascular Clinical Affairs
• Original Responsible Party: ev3 Neurovascular, ev3 Endovascular, Inc
• Current Study Sponsor: Medtronic Neurovascular Clinical Affairs
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jeffrey L. Saver, MD; University of California, Los Angeles

• PRS Account: Medtronic Neurovascular Clinical Affairs
• Verification Date: August 2016