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

Ischemic Stroke Clinical Trial

— SWIFT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01054560
• Other study ID #: SWIFT
• Status: Active, not recruiting
• Phase: N/A
• First received: December 10, 2009
• Last updated: June 6, 2011
• Start date: January 2010
• Est. completion date: December 2011

Study information

• Verified date: June 2011
• Source: ev3
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemic Stroke

Intervention

Device:
• SOLITAIRE™ Device compared to MERCI® Device
SOLITAIRE™ Device (investigational device) compared with the commercially available device, MERCI® Device

Locations

Country	Name	City	State
United States	Oregon Stroke Center	Portland	Oregon
United States	Multicare Health System	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
ev3

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Immediately post treatment	No
Secondary	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		30 and 90 days post treatment	No

External Links

•   American Heart Association - Stroke
•   ev3, Inc.