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Solitaire With the Intention For Thrombectomy as PRIMary Endovascular Treatment (SWIFT PRIME) Trial (SWIFT PRIME)

This study has been completed.
Information provided by (Responsible Party):
Medtronic - MITG Identifier:
First received: August 2, 2012
Last updated: February 25, 2015
Last verified: February 2015
This study is to determine if patients experiencing an Acute Ischemic Stroke due to large vessel occlusion, treated with combined IV t-PA and Solitaire FR within 6 hours of symptom onset have less stroke-related disability than those patients treated with IV t-PA alone.

Condition Intervention
Acute Ischemic Stroke
Drug: intravenous (IV) recombinant human tissue plasminogen activator (rtPA)
Device: Solitaire FR

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Solitaire™ FR With the Intention For Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) Clinical Trial

Further study details as provided by Medtronic - MITG:

Primary Outcome Measures:
  • 90-day global disability assessed via the blinded evaluation of modified Rankin score (mRS). [ Time Frame: 90 days ]

Secondary Outcome Measures:
  • Death due to any cause at 90 days [ Time Frame: 90 days ]
  • Functional independence as defined by modified Rankin Scale (mRS) score ≤2 at 90 days [ Time Frame: 90 days ]
  • Change in NIH Stroke Scale score at 27 ± 6 hrs post randomization [ Time Frame: 27 hrs ]

Enrollment: 196
Study Start Date: November 2012
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV t-PA with SOLITAIRE™ FR Device
Dual IV tPA therapy and adjunctive treatment with the Solitaire FR
Device: Solitaire FR
Active Comparator: IV t-PA
IV infusion of tPA
Drug: intravenous (IV) recombinant human tissue plasminogen activator (rtPA)


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age 18 - 80
  2. Clinical signs consistent with acute ischemic stroke
  3. Prestroke Modified Rankin Score ≤ 1
  4. NIHSS ≥ 8 and < 30 at the time of randomization
  5. Initiation of IV t-PA within 4.5 hours of onset of stroke symptoms (onset time is defined as the last time when the patient was witnessed to be at baseline), with investigator verification that the subject has received / is receiving the correct IV t-PA dose for the estimated weight prior to randomization.
  6. Thrombolysis in Cerebral Infarction (TICI) 0-1 flow in the intracranial internal carotid artery, M1 segment of the MCA, or carotid terminus confirmed by CT or MR angiography that is accessible to the Solitaire™ FR Device.
  7. Subject is able to be treated within 6 hours of onset of stroke symptoms and within 1.5 hours (90 minutes) from CTA or MRA to groin puncture.
  8. Subject is willing to conduct protocol-required follow-up visits.
  9. An appropriate signed and dated Informed Consent Form (as allowed according to country regulations and approved by ethics committee and/or IRB) has been obtained
  10. Subject is affiliated with a social security system (if required by individual country regulations).
  11. Subject meets national regulatory criteria for clinical trial participation.

Exclusion Criteria:

  1. Subject who is contraindicated to IV t-PA as per local national guidelines.
  2. Female who is pregnant or lactating or has a positive pregnancy test at time of admission.
  3. As applicable by French law, subject who is a protected individual such as an incompetent adult or incarcerated person.
  4. Rapid neurological improvement prior to study randomization suggesting resolution of signs/symptoms of stroke.
  5. Known serious sensitivity to radiographic contrast agents.
  6. Known sensitivity to Nickel, Titanium metals or their alloys.
  7. Current participation in another investigational drug or device treatment study.
  8. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency. (A subject without history or suspicion of coagulopathy does not require INR or prothrombin time lab results to be available prior to enrollment.)
  9. Renal Failure as defined by a serum creatinine > 2.0 mg/dl (or 176.8 μmol/l) or Glomerular Filtration Rate [GFR] < 30Warfarin therapy with INR greater than 1.7.
  10. Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason
  11. Life expectancy of less than 90 days.
  12. Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal.
  13. Suspicion of aortic dissection.
  14. Subject with a co-morbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.
  15. Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day).
  16. Known history of arterial tortuosity, pre-existing stent, and/or other arterial disease which would prevent the device from reaching the target vessel and/or preclude safe recovery of the device.

Imaging Exclusion Criteria:

  1. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of hemorrhage on presentation.
  2. CT or MRI evidence of mass effect or intra-cranial tumor (except small meningioma).
  3. CT or MRI evidence of cerebral vasculitis.
  4. CT showing hypodensity or MRI showing hyperintensity involving greater than 1/3 of the middle cerebral artery (MCA) territory (or in other territories, >100 cc of tissue) on presentation.
  5. Baseline non-contrast CT or DWI MRI evidence of a moderate/large core defined as extensive early ischemic changes of Alberta Stroke Program Early CT score (ASPECTS) < 6.
  6. CT or MRI evidence of a basilar artery (BA) occlusion or posterior cerebral artery (PCA) occlusion.
  7. CTA or MRA evidence of carotid dissection or complete cervical carotid occlusion requiring stenting at the time of the index procedure (i.e., mechanical thrombectomy)
  8. Imaging evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target lesion, moderate/large infarct with poor collateral circulation, etc).
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Please refer to this study by its identifier: NCT01657461

United States, New York
Kaleida Health/Buffalo General
Buffalo, New York, United States, 14203
Sponsors and Collaborators
Medtronic - MITG
Principal Investigator: Jeffrey Saver, MD University of California, Los Angeles
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medtronic - MITG Identifier: NCT01657461     History of Changes
Other Study ID Numbers: NV-SFR004
Study First Received: August 2, 2012
Last Updated: February 25, 2015

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on April 26, 2017