- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01657461
Solitaire™ With the Intention For Thrombectomy as PRIMary Endovascular Treatment (SWIFT PRIME) Trial (SWIFT PRIME)
April 7, 2017 updated by: Medtronic Neurovascular Clinical Affairs
Solitaire™ FR With the Intention For Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) Clinical Trial
The primary study objective is to determine if subjects experiencing an acute ischemic stroke due to large vessel occlusion, treated with combined IV t-PA and Solitaire Revascularization Device within 6 hours of symptom onset have less stroke-related neurological disability (mRS) than those subjects treated with IV t-PA alone
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
196
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Buffalo, New York, United States, 14203
- Kaleida Health/Buffalo General
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 - 80
- Clinical signs consistent with acute ischemic stroke
- Prestroke Modified Rankin Score ≤ 1
- NIHSS ≥ 8 and < 30 at the time of randomization
- 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.
- 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.
- 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.
- Subject is willing to conduct protocol-required follow-up visits.
- 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
- Subject is affiliated with a social security system (if required by individual country regulations).
- Subject meets national regulatory criteria for clinical trial participation.
Exclusion Criteria:
- Subject who is contraindicated to IV t-PA as per local national guidelines.
- Female who is pregnant or lactating or has a positive pregnancy test at time of admission.
- As applicable by French law, subject who is a protected individual such as an incompetent adult or incarcerated person.
- Rapid neurological improvement prior to study randomization suggesting resolution of signs/symptoms of stroke.
- Known serious sensitivity to radiographic contrast agents.
- Known sensitivity to Nickel, Titanium metals or their alloys.
- Current participation in another investigational drug or device treatment study.
- 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.)
- 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.
- Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason
- Life expectancy of less than 90 days.
- Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal.
- Suspicion of aortic dissection.
- 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.
- 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).
- 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:
- Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of hemorrhage on presentation.
- CT or MRI evidence of mass effect or intra-cranial tumor (except small meningioma).
- CT or MRI evidence of cerebral vasculitis.
- 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.
- 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.
- CT or MRI evidence of a basilar artery (BA) occlusion or posterior cerebral artery (PCA) occlusion.
- 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)
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: IV t-PA with Solitaire™ revascularization device
Dual IV tPA therapy and adjunctive treatment with the Solitaire revascularization device
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Clot retrieval with the Solitaire revascularization device after patients have received standard therapy with intravenous tissue plasminogen activator
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ACTIVE_COMPARATOR: IV t-PA
Infusion of intravenous tissue plasminogen activator (IV t-PA)
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Standard therapy with Intravenous (IV) recombinant human tissue plasminogen activator (rtPA)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS).
Time Frame: 90 days
|
mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. 0 No symptoms at all
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Death Due to Any Cause at 90 Days
Time Frame: 90 days
|
90 days
|
|
Functional Independence as Defined by Modified Rankin Scale (mRS) Score ≤2 at 90 Days
Time Frame: 90 days
|
90 days
|
|
Change in NIH Stroke Scale Score at 27 ± 6 Hrs Post Randomization
Time Frame: Baseline to 27±6 hours post randomization
|
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss.
NIHSS scores range from 0 - 42.
A score of 0 indicates no stroke symptoms.
Higher scores indicate incremental levels of neurological impairment.
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Baseline to 27±6 hours post randomization
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Volume of Cerebral Infarction as Measured by a CT or MRI Scan at 27±6 Hours Post Randomization
Time Frame: 27±6 hours post randomization
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27±6 hours post randomization
|
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Reperfusion Measured by Reperfusion Ratio on CT or MRI Scan 27±6 Hours Post Randomization
Time Frame: 27±6 hours post randomization
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27±6 hours post randomization
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Arterial Revascularization Measured by TICI 2b or 3 Following Device Use
Time Frame: Post procedure
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Post procedure
|
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Correlation of RAPID-assessed Core Infarct Volume With 27±6 Hours Post Randomization Stroke Infarction in Subjects Who Achieved TICI 2b-3 Reperfusion Without Intracranial Hemorrhage
Time Frame: 27±6 hours post randomization
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27±6 hours post randomization
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of All Serious Adverse Events (SAEs)
Time Frame: Through 90 days
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Through 90 days
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Incidence of sICH at 27±6 Hours Post Randomization
Time Frame: 27±6 hours post randomization
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27±6 hours post randomization
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Raychev R, Saver JL, Jahan R, Nogueira RG, Goyal M, Pereira VM, Gralla J, Levy EI, Yavagal DR, Cognard C, Liebeskind DS. The impact of general anesthesia, baseline ASPECTS, time to treatment, and IV tPA on intracranial hemorrhage after neurothrombectomy: pooled analysis of the SWIFT PRIME, SWIFT, and STAR trials. J Neurointerv Surg. 2020 Jan;12(1):2-6. doi: 10.1136/neurintsurg-2019-014898. Epub 2019 Jun 25. Erratum In: J Neurointerv Surg. 2021 Sep;13(9):e21.
- Eker OF, Saver JL, Goyal M, Jahan R, Levy EI, Nogueira RG, Yavagal DR, Bonafe A; SWIFT PRIME investigators. Impact of Anesthetic Management on Safety and Outcomes Following Mechanical Thrombectomy for Ischemic Stroke in SWIFT PRIME Cohort. Front Neurol. 2018 Aug 29;9:702. doi: 10.3389/fneur.2018.00702. eCollection 2018.
- Kaneko N, Komuro Y, Yokota H, Tateshima S. Stent retrievers with segmented design improve the efficacy of thrombectomy in tortuous vessels. J Neurointerv Surg. 2019 Feb;11(2):119-122. doi: 10.1136/neurintsurg-2018-014061. Epub 2018 Jul 24.
- Arenillas JF, Cortijo E, Garcia-Bermejo P, Levy EI, Jahan R, Liebeskind D, Goyal M, Saver JL, Albers GW. Relative cerebral blood volume is associated with collateral status and infarct growth in stroke patients in SWIFT PRIME. J Cereb Blood Flow Metab. 2018 Oct;38(10):1839-1847. doi: 10.1177/0271678X17740293. Epub 2017 Nov 14. Erratum In: J Cereb Blood Flow Metab. 2018 Jan 1;:271678X18765354.
- Raychev R, Jahan R, Saver JL, Nogueira RG, Goyal M, Pereira VM, Levy E, Yavagal DR, Cognard C, Liebeskind D. Microcatheter contrast injection in stent retriever neurothrombectomy is safe and useful: insights from SWIFT PRIME. J Neurointerv Surg. 2018 Jul;10(7):615-619. doi: 10.1136/neurintsurg-2017-013397. Epub 2017 Nov 10.
- Menjot de Champfleur N, Saver JL, Goyal M, Jahan R, Diener HC, Bonafe A, Levy EI, Pereira VM, Cognard C, Yavagal DR, Albers GW. Efficacy of Stent-Retriever Thrombectomy in Magnetic Resonance Imaging Versus Computed Tomographic Perfusion-Selected Patients in SWIFT PRIME Trial (Solitaire FR With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke). Stroke. 2017 Jun;48(6):1560-1566. doi: 10.1161/STROKEAHA.117.016669. Epub 2017 May 2.
- Mokin M, Levy EI, Saver JL, Siddiqui AH, Goyal M, Bonafe A, Cognard C, Jahan R, Albers GW; SWIFT PRIME Investigators. Predictive Value of RAPID Assessed Perfusion Thresholds on Final Infarct Volume in SWIFT PRIME (Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment). Stroke. 2017 Apr;48(4):932-938. doi: 10.1161/STROKEAHA.116.015472. Epub 2017 Mar 10.
- Shireman TI, Wang K, Saver JL, Goyal M, Bonafe A, Diener HC, Levy EI, Pereira VM, Albers GW, Cognard C, Hacke W, Jansen O, Jovin TG, Mattle HP, Nogueira RG, Siddiqui AH, Yavagal DR, Devlin TG, Lopes DK, Reddy VK, du Mesnil de Rochemont R, Jahan R, Vilain KA, House J, Lee JM, Cohen DJ; SWIFT-PRIME Investigators. Cost-Effectiveness of Solitaire Stent Retriever Thrombectomy for Acute Ischemic Stroke: Results From the SWIFT-PRIME Trial (Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke). Stroke. 2017 Feb;48(2):379-387. doi: 10.1161/STROKEAHA.116.014735. Epub 2016 Dec 27.
- Albers GW, Goyal M, Jahan R, Bonafe A, Diener HC, Levy EI, Pereira VM, Cognard C, Yavagal DR, Saver JL. Relationships Between Imaging Assessments and Outcomes in Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke. Stroke. 2015 Oct;46(10):2786-94. doi: 10.1161/STROKEAHA.115.010710. Epub 2015 Aug 27.
- Saver JL, Goyal M, Bonafe A, Diener HC, Levy EI, Pereira VM, Albers GW, Cognard C, Cohen DJ, Hacke W, Jansen O, Jovin TG, Mattle HP, Nogueira RG, Siddiqui AH, Yavagal DR, Baxter BW, Devlin TG, Lopes DK, Reddy VK, du Mesnil de Rochemont R, Singer OC, Jahan R; SWIFT PRIME Investigators. Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. N Engl J Med. 2015 Jun 11;372(24):2285-95. doi: 10.1056/NEJMoa1415061. Epub 2015 Apr 17.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (ACTUAL)
January 1, 2015
Study Completion (ACTUAL)
January 1, 2015
Study Registration Dates
First Submitted
August 2, 2012
First Submitted That Met QC Criteria
August 3, 2012
First Posted (ESTIMATE)
August 6, 2012
Study Record Updates
Last Update Posted (ACTUAL)
May 18, 2017
Last Update Submitted That Met QC Criteria
April 7, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NV-SFR004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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