Acute Ischemic StrokeSWIFT PRIMENCT01657461
Solitaire™ With the Intention For Thrombectomy as PRIMary Endovascular Treatment (SWIFT PRIME) Trial
A study testing Intravenous (IV) recombinant human tissue plasminogen activator (rtPA) and Solitaire revascularization device in people with Acute Ischemic Stroke, run by Medtronic Neurovascular Clinical Affairs at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Intravenous (IV) recombinant human tissue plasminogen activator (rtPA) and Solitaire revascularization device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaleida Health/Buffalo General
Buffalo, New York, 14203
About this study
Official title: 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
- Conditions
- Acute Ischemic Stroke
- Being tested
- Intravenous (IV) recombinant human tissue plasminogen activator (rtPA), Solitaire revascularization device
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous (IV) recombinant human tissue plasminogen activator (rtPA)Drug
Standard therapy with Intravenous (IV) recombinant human tissue plasminogen activator (rtPA)
Solitaire revascularization deviceDevice
Clot retrieval with the Solitaire revascularization device after patients have received standard therapy with intravenous tissue plasminogen activator
| Study group | Role | What they receive |
|---|---|---|
| IV t-PA with Solitaire™ revascularization device | Experimental | Dual IV tPA therapy and adjunctive treatment with the Solitaire revascularization device Receives: Device: Solitaire revascularization device |
| IV t-PA | Active comparator | Infusion of intravenous tissue plasminogen activator (IV t-PA) Receives: Drug: Intravenous (IV) recombinant human tissue plasminogen activator (rtPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS).
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
- No significant disability despite symptoms; able to carry out all usual duties and activities
- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
- Moderate disability; requiring some help, but able to walk without assistance
- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
- Severe disability; bedridden, incontinent and requiring constant nursing care and attention
- Dead
Measured: 90 days
Secondary outcomes (7)
Death Due to Any Cause at 90 Days
Measured: 90 days
Functional Independence as Defined by Modified Rankin Scale (mRS) Score ≤2 at 90 Days
Measured: 90 days
Change in NIH Stroke Scale Score at 27 ± 6 Hrs 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.
Measured: Baseline to 27±6 hours post randomization
Volume of Cerebral Infarction as Measured by a CT or MRI Scan at 27±6 Hours Post Randomization
Measured: 27±6 hours post randomization
Reperfusion Measured by Reperfusion Ratio on CT or MRI Scan 27±6 Hours Post Randomization
Measured: 27±6 hours post randomization
Arterial Revascularization Measured by TICI 2b or 3 Following Device Use
Measured: Post procedure
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
Measured: 27±6 hours post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startDec 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Neurovascular Clinical Affairs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Saver, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657461
- Sponsor's protocol ID
- NV-SFR004
- Acronym
- SWIFT PRIME
- Status last verified
- Apr 2017
- First submitted
- 2 Aug 2012
- Last updated
- 18 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 31239326Eker 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.
PubMed 30210431Kaneko 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.
PubMed 30045949Arenillas 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.
PubMed 29135347Raychev 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.
PubMed 29127195Menjot 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.
PubMed 28465460Mokin 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.
PubMed 28283606Shireman 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.
PubMed 28028150Albers 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.
PubMed 26316344Saver 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.
PubMed 25882376
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Solitaire™ FR With the Intention For Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) Clinical Trial
- ClinicalTrials.gov ID
- NCT01657461
- Acronym / sponsor ID
- SWIFT PRIME / NV-SFR004
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Medtronic Neurovascular Clinical AffairsIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 6 Aug 2012 (estimated)
- Results
- Posted 18 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV t-PA with Solitaire™ revascularization device | Experimental | Device: Solitaire revascularization deviceDual IV tPA therapy and adjunctive treatment with the Solitaire revascularization device |
| IV t-PA | Active comparator | Drug: Intravenous (IV) recombinant human tissue plasminogen activator (rtPA)Infusion of intravenous tissue plasminogen activator (IV t-PA) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous (IV) recombinant human tissue plasminogen activator (rtPA)Standard therapy with Intravenous (IV) recombinant human tissue plasminogen activator (rtPA) | Drug | IV t-PA |
| Solitaire revascularization deviceClot retrieval with the Solitaire revascularization device after patients have received standard therapy with intravenous tissue plasminogen activator | Device | IV t-PA with Solitaire™ revascularization device |
Primary outcome
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 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
7 secondary outcomes
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: Baseline to 27±6 hours post randomization
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
Reperfusion Measured by Reperfusion Ratio on CT or MRI Scan 27±6 Hours Post Randomization
Time frame: 27±6 hours post randomization
Arterial Revascularization Measured by TICI 2b or 3 Following Device Use
Time frame: Post procedure
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31239326Raychev 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.
- Derived from this study: PubMed 30210431Eker 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.
- Derived from this study: PubMed 30045949Kaneko 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.
- Derived from this study: PubMed 29135347Arenillas 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.
- Derived from this study: PubMed 29127195Raychev 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.
- Derived from this study: PubMed 28465460Menjot 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.
- Derived from this study: PubMed 28283606Mokin 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.
- Derived from this study: PubMed 28028150Shireman 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.
- Derived from this study: PubMed 26316344Albers 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.
- Derived from this study: PubMed 25882376Saver 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Saver, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous (IV) recombinant human tissue plasminogen activator (rtPA) and Solitaire revascularization device in people with Acute Ischemic Stroke, run by Medtronic Neurovascular Clinical Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS). (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01657461, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2017.