SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study
This study is ongoing, but not recruiting participants.
Sponsor:
ev3
Information provided by:
ev3
ClinicalTrials.gov Identifier:
NCT01054560
First received: December 10, 2009
Last updated: June 6, 2011
Last verified: June 2011
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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 |
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
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:
ev3, Inc. 
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 May 23, 2013