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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by ev3.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
ev3
ClinicalTrials.gov Identifier:
NCT01054560
First received: December 10, 2009
Last updated: June 6, 2011
Last verified: June 2011

December 10, 2009
June 6, 2011
January 2010
July 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01054560 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study
SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ischemic Stroke
Device: SOLITAIRE™ Device compared to MERCI® Device
SOLITAIRE™ Device (investigational device) compared with the commercially available device, MERCI® Device
  • Experimental: SOLITAIRE™ Device
    The SOLITAIRE™ Device (investigational device) is the experimental arm
    Intervention: Device: SOLITAIRE™ Device compared to MERCI® Device
  • Active Comparator: MERCI® Device
    The MERCI® Device (control device) is commercially available.
    Intervention: Device: SOLITAIRE™ Device compared to MERCI® Device

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
December 2011
July 2011   (final data collection date for primary outcome measure)

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
  • NIHSS≥8and<30
  • Thrombolysis in Myocardial Infarction TIMI 0 or TIMI 1 flow in the M1 or M2 of MCA, ICA, 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 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
Both
22 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01054560
SWIFT
Yes
ev3 Neurovascular, ev3 Endovascular, Inc
ev3
Not Provided
Principal Investigator: Jeffrey L. Saver, MD University of California, Los Angeles
ev3
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP