Solitaire™ FR as Primary Treatment for Acute Ischemic Stroke (SWIFT PRIME)

This study is currently recruiting participants.
Verified March 2013 by Covidien
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01657461
First received: August 2, 2012
Last updated: March 6, 2013
Last verified: March 2013
  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 ±3hrs 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 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 - 85
  2. Clinical signs consistent with acute ischemic stroke
  3. No prestroke functional dependence (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 1.5 hours (90 minutes) from CTP or DWI/PWI MR to groin puncture.
  8. Subject is willing to conduct protocol-required follow-up visits.
  9. Subject or subject's legally authorized representative has signed and dated an Informed Consent Form according to country regulations, ethics committee, and/or IRB requirements.

Exclusion Criteria:

  1. History of stroke in the past 3 months.
  2. Female who is pregnant or lactating or has a positive pregnancy test at time of admission.
  3. Rapid neurological improvement prior to study randomization suggesting resolution of signs/symptoms of stroke.
  4. Known serious sensitivity to radiographic contrast agents.
  5. Current participation in another investigational drug or device treatment study.
  6. Uncontrolled hypertension defined as systolic blood pressure > 185 or diastolic blood pressure > 110 that cannot be controlled except with continuous parenteral antihypertensive medication.
  7. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency. (Patients without history or suspicion of coagulopathy do not require INR or prothrombin time lab results to be available prior to enrollment.)
  8. Warfarin therapy with INR greater than 1.7.
  9. Low molecular Weight Heparins (such as Dalteparin, Enoxaparin, Tinzaparin, Fondaparinux) as DVT prophylaxis or in full dose within the last 24 hours from screening.
  10. Subject who has received heparin or a direct thrombin inhibitor (e.g. rivaroxaban, Angiomax™, argatroban, Refludan™) within the last 48 hours must have a normal partial thromboplastin time (PTT) to be eligible.
  11. Subject who has received factor Xa inhibitor therapy (e.g. dabigatran) within the past 24 hours must have a normal ecarin clotting time to be eligible. Subject who has received factor Xa inhibitor therapy more than 24 hours ago but less than 48 hours ago must have a normal partial thromboplastin time (PTT) to be eligible.
  12. Baseline lab values: glucose < 50 mg/dl or > 400 mg/dl, platelets < 100,000, or Hct < 25.
  13. Renal Failure as defined by a serum creatinine > 2.0 or Glomerular Filtration Rate [GFR] < 30.
  14. Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason.
  15. Life expectancy of less than 90 days.
  16. Previous intra-cranial hemorrhage, neoplasm, subarachnoid hemorrhage, cerebral aneurysm, or arteriovenous malformation.
  17. Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal.
  18. Presumed septic embolus, or suspicion of bacterial endocarditis.
  19. Presumed pericarditis including pericarditis after acute myocardial infarction.
  20. Suspicion of aortic dissection.
  21. Surgery or biopsy of parenchymal organ within 30 days.
  22. Trauma with internal injuries or ulcerative wounds within 30 days.
  23. Severe head trauma or head trauma with loss of consciousness within 90 days.
  24. Any active or recent hemorrhage within 30 days.
  25. Cerebral vasculitis.
  26. Subject with a pre-existing neurological or psychiatric disease that would confound the neurological and functional evaluations.

Imaging Exclusion Criteria:

  1. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of hemorrhage on presentation.
  2. 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.
  3. CT or MRI evidence of mass effect or intra-cranial tumor (except small meningioma).
  4. Core Infarct and hypoperfusion:

    • MRI- or CT-assessed core infarct lesion greater than 50 cc;
    • Severe hypoperfusion lesion (10 sec or more Tmax lesion larger than 100 cc)
    • Ischemic penumbra < 15 cc and mismatch ratio ≤1.8.
  5. Angiographic evidence of carotid dissection or complete cervical carotid occlusion.
  6. Arterial tortuosity, calcification, pre-existing stent, and/or stenosis which would prevent the device from reaching the target vessel and/or preclude safe recovery of the device.
  Contacts and Locations
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: March 6, 2013
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 April 17, 2014