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
  Purpose

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.


Condition Intervention
Ischemic Stroke
Device: SOLITAIRE™ Device compared to MERCI® Device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study

Resource links provided by NLM:


Further study details as provided by ev3:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: January 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SOLITAIRE™ Device
The SOLITAIRE™ Device (investigational device) is the experimental arm
Device: SOLITAIRE™ Device compared to MERCI® Device
SOLITAIRE™ Device (investigational device) compared with the commercially available device, MERCI® Device
Active Comparator: MERCI® Device
The MERCI® Device (control device) is commercially available.
Device: SOLITAIRE™ Device compared to MERCI® Device
SOLITAIRE™ Device (investigational device) compared with the commercially available device, MERCI® Device

  Eligibility

Ages Eligible for Study:   22 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01054560

Locations
United States, Oregon
Oregon Stroke Center
Portland, Oregon, United States
United States, Washington
Multicare Health System
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
ev3
Investigators
Principal Investigator: Jeffrey L. Saver, MD University of California, Los Angeles
  More Information

Additional Information:
No publications provided by ev3

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ev3 Neurovascular, ev3 Endovascular, Inc
ClinicalTrials.gov Identifier: NCT01054560     History of Changes
Other Study ID Numbers: SWIFT
Study First Received: December 10, 2009
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by ev3:
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

Additional relevant MeSH terms:
Ischemia
Stroke
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014