Trial record 1 of 1 for:    01657461
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Solitaire™ FR as Primary Treatment for Acute Ischemic Stroke (SWIFT PRIME)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Covidien
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01657461
First received: August 2, 2012
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • 90-day global disability assessed via the blinded evaluation of modified Rankin score (mRS). [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death due to any cause at 90 days [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Functional independence as defined by modified Rankin Scale (mRS) score ≤2 at 90 days [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Change in NIH Stroke Scale score at 27 ± 6 hrs post randomization [ Time Frame: 27 hrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 833
Study Start Date: November 2012
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: June 2018 (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)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  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: NCT01657461

Locations
United States, New York
Kaleida Health/Buffalo General Recruiting
Buffalo, New York, United States, 14203
Contact: Jennifer Gay    716-888-4811      
Principal Investigator: Adnan Siddiqui, MD         
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Jeffrey Saver, MD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01657461     History of Changes
Other Study ID Numbers: NV-SFR004
Study First Received: August 2, 2012
Last Updated: June 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Plasminogen
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on July 31, 2014