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

NCT01054560 | Completed Results DMC

• 1 other identifier: SWIFT
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

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.

Conditions

Ischemic Stroke

Keywords

Ischemic Stroke; SOLITAIRE™ Device; SOLITAIRE™; MERCI® Device; MERCI®; Stroke; Ischemic; Mechanical Thrombectomy; Brain; Brain Clot; Brain Artery Revascularization; Recanalization; Brain Stroke; Clot Retriever; Device; Neurosurgery; Neurovascular Intervention; Interventional Neuroradiology; Brain study; neurovascular clinical trial

Outcome Measures

Primary Outcomes (3)

• Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage

  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)

  Immediately post treatment

• Study Device-related Serious Adverse Events (SAEs)

  Incidence of study device-related Serious Adverse Events (SAEs)

  90 Day

• Procedure-related Serious Adverse Events (SAEs)

  Incidence of study procedure-related Serious Adverse Events (SAEs)

  90 Day

Secondary Outcomes (6)

• Time to Initial Recanalization

  post treatment

• Good Neurological Outcome at 30 Days

  30 Days Follow-up

• Good Neurological Outcome 90 Days

  90 Days Follow-up

• Mortality

  90 Days follow-up

• Symptomatic Intracranial Hemorrhage

  24 hours

Study Arms (2)

SOLITAIRE™ Device

EXPERIMENTAL

The SOLITAIRE™ Device (investigational device) is the experimental arm

Device: SOLITAIRE™ Device

MERCI® Device

ACTIVE COMPARATOR

The MERCI® Device (control device) is commercially available.

Device: MERCI® Device

Interventions

SOLITAIRE™ Device DEVICE

The SOLITAIRE™ Device is the experimental device that will be used in the interventional procedure

SOLITAIRE™ Device

MERCI® Device DEVICE

The MERCI® Device is the control device that will be used in the interventional procedure.

MERCI® Device

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Neurovascular Clinical Affairs: lead

Study Sites (2)

Oregon Stroke Center

Portland, Oregon, United States

Location

Multicare Health System

Tacoma, Washington, 98405, United States

Location

Related Publications (7)

• 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.

  PMID: 31239326 DERIVED

• 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.

  PMID: 28097310 DERIVED

• 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.

  PMID: 26658447 DERIVED

• 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.

  PMID: 25676147 DERIVED

• 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.

  PMID: 24876081 DERIVED

• 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.

  PMID: 24525954 DERIVED

• 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.

  PMID: 22932715 DERIVED

Related Links

• American Heart Association - Stroke
• ev3, Inc.

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Covidien

9498373700

Study Officials

• Jeffrey L. Saver, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: January 22, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 26, 2016
• Results First Posted: October 26, 2016

Record last verified: 2016-08

Locations

US (2)