AzTrials
AzTrials

Ischemic StrokeSWIFTNCT01054560

SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study

A study testing SOLITAIRE™ Device and MERCI® Device in people with Ischemic Stroke, run by Medtronic Neurovascular Clinical Affairs at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to demonstrate substantial equivalence of the SOLITAIRE™ FR Revascularization Device (SOLITAIRE™ Device) with a legally marketed device, MERCI Retrieval System® (MERCI® Device). Read more about this study

Who is it for?
Ages 22 to 85 years
Conditions the study is for
Ischemic Stroke
What is being tested?
SOLITAIRE™ Device and MERCI® Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
2 sitesUnited States
Study dates
Jan 2010to Jul 2011
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 22 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient or patient's legally authorized representative has signed and dated an Informed Consent Form
  • Age22-85
  • Clinical signs consistent with acute ischemic stroke
  • National Institutes of Health Stroke Scale (NIHSS) ≥8and<30
  • Thrombolysis in Myocardial Infarction (TIMI) 0 or TIMI 1 flow in the M1 or M2 of middle cerebral artery, internal carotid artery, basilar or vertebral arteries confirmed by angiography that is accessible to the SOLITAIRETM or MERCI® Device
  • Patient is able to be treated within 8 hours of stroke symptoms onset with minimum of one deployment of the SOLITAIRETM or MERCI® Device.
  • Patient who is ineligible or failed intravenous tissue plasminogen activator (t-PA) therapy given at local institutions or within national practice.
  • Patient is willing to conduct follow-up visits

Who cannot join

  • NIHSS > 30 or coma
  • Neurological signs that are rapidly improving prior to or at time of treatment
  • Females who are pregnant or lactating
  • Known serious sensitivity to radiographic contrast agents
  • Current participation in another investigation drug or device study
  • Uncontrolled hypertension defined as systolic blood pressure > 185 or diastolic blood pressure > 110 that cannot be controlled except with continuous parenteral antihypertensive medication
Show all 15Show fewer
  • Use of warfarin anticoagulation with International Normalized Ratio (INR) > 3.0
  • Platelet count < 30,000
  • Glucose < 50 mg/dL
  • Arterial tortuosity that would prevent the device from reaching the target vessel
  • Life expectancy of less than 90 days
  • Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of hemorrhage on presentation
  • CT showing hypodensity or MR showing hyperintensity involving greater than 1/3 of the middle cerebral artery (MCA) territory (or in other territories, >100 cc of tissue) on presentation
  • CT or MRI evidence of mass effect or intracranial tumor (except small meningioma)
  • Angiographic evidence of carotid dissection, complete cervical carotid occlusions, or vasculitis

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Oregon Stroke Center

    Portland, Oregon

  • Multicare Health System

    Tacoma, Washington, 98405

Other trials in United States

About this study

The purpose of this study is to demonstrate substantial equivalence of the SOLITAIRE™ FR Revascularization Device (SOLITAIRE™ Device) with a legally marketed device, MERCI Retrieval System® (MERCI® Device). The study will demonstrate safety and efficacy of the SOLITAIRE™ Device in subjects requiring mechanical thrombectomy diagnosed with acute ischemic stroke.

Conditions
Ischemic Stroke
Being tested
SOLITAIRE™ Device, MERCI® Device
Keywords
Ischemic Stroke, SOLITAIRE™ Device, SOLITAIRE™, MERCI® Device, MERCI®, Stroke, Ischemic, Mechanical Thrombectomy, Brain, Brain Clot, Brain Artery Revascularization, Recanalization, Brain Stroke, Clot Retriever, Device, Neurosurgery, Neurovascular Intervention, Interventional Neuroradiology, Brain study, neurovascular clinical trial
Medical subject headings
Ischemic Stroke, Stroke, Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SOLITAIRE™ DeviceDevice

    The SOLITAIRE™ Device is the experimental device that will be used in the interventional procedure

  • MERCI® DeviceDevice

    The MERCI® Device is the control device that will be used in the interventional procedure.

Study groups in NCT01054560
Study groupRoleWhat they receive
SOLITAIRE™ DeviceExperimentalThe SOLITAIRE™ Device (investigational device) is the experimental arm
Receives: Device: SOLITAIRE™ Device
MERCI® DeviceActive comparatorThe MERCI® Device (control device) is commercially available.
Receives: Device: MERCI® Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage

    Successful arterial recanalization of occluded target vessel measured by Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following the use of the SOLITAIRE™ or MERCI® Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes.

    Thrombolysis in Myocardial Infarction (TIMI) score describes the distal flow perfusion and revascularization before and following therapy.

    TIMI 0 - No perfusion (worst outcome) TIMI 1 - Perfusion past the initial occlusion, but no distal branch filling TIMI 2 - Perfusion with incomplete or slow distal branch filling TIMI 3 - Full perfusion with filling of all distal branches (best outcome)

    Measured: Immediately post treatment

  2. Study Device-related Serious Adverse Events (SAEs)

    Incidence of study device-related Serious Adverse Events (SAEs)

    Measured: 90 Day

  3. Procedure-related Serious Adverse Events (SAEs)

    Incidence of study procedure-related Serious Adverse Events (SAEs)

    Measured: 90 Day

Secondary outcomes (6)

  1. Time to Initial Recanalization

    Time from guide catheter placement to first visualization of Thrombolysis in Myocardial Infarction (TIMI) 2 flow

    Measured: post treatment

  2. Good Neurological Outcome at 30 Days

    Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more

    Measured: 30 Days Follow-up

  3. Good Neurological Outcome 90 Days

    Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more

    Measured: 90 Days Follow-up

  4. Mortality

    Rate of Mortality

    Measured: 90 Days follow-up

  5. Symptomatic Intracranial Hemorrhage

    Symptomatic hemorrhage within 24 hours of procedure. Symptomatic hemorrhages is defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a worsening of National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24hrs.

    Measured: 24 hours

  6. Non-fatal Stroke-related Morbidity

    Morbidity data is presented in terms of subjects with permanent deficit as a result of one or more adverse events

    Measured: 90 Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionJul 2011
  4. Study completionJul 2011

Resources

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
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01054560
Sponsor's protocol ID
SWIFT
Acronym
SWIFT
Status last verified
Aug 2016
First submitted
10 Dec 2009
Last updated
26 Oct 2016
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 31239326

  • Coutinho JM, Liebeskind DS, Slater LA, Nogueira RG, Clark W, Davalos A, Bonafe A, Jahan R, Fischer U, Gralla J, Saver JL, Pereira VM. Combined Intravenous Thrombolysis and Thrombectomy vs Thrombectomy Alone for Acute Ischemic Stroke: A Pooled Analysis of the SWIFT and STAR Studies. JAMA Neurol. 2017 Mar 1;74(3):268-274. doi: 10.1001/jamaneurol.2016.5374.

    PubMed 28097310

  • Kim JT, Jahan R, Saver JL; SWIFT Investigators. Impact of Glucose on Outcomes in Patients Treated With Mechanical Thrombectomy: A Post Hoc Analysis of the Solitaire Flow Restoration With the Intention for Thrombectomy Study. Stroke. 2016 Jan;47(1):120-7. doi: 10.1161/STROKEAHA.115.010753. Epub 2015 Dec 10.

    PubMed 26658447

  • Sheth SA, Jahan R, Levy EI, Jovin TG, Baxter B, Nogueira RG, Clark W, Budzik R, Zaidat OO, Saver JL; SWIFT Trialists. Rapid learning curve for Solitaire FR stent retriever therapy: evidence from roll-in and randomised patients in the SWIFT trial. J Neurointerv Surg. 2016 Apr;8(4):347-52. doi: 10.1136/neurintsurg-2014-011627. Epub 2015 Feb 12.

    PubMed 25676147

  • Liebeskind DS, Jahan R, Nogueira RG, Zaidat OO, Saver JL; SWIFT Investigators. Impact of collaterals on successful revascularization in Solitaire FR with the intention for thrombectomy. Stroke. 2014 Jul;45(7):2036-40. doi: 10.1161/STROKEAHA.114.004781. Epub 2014 May 29.

    PubMed 24876081

  • Liebeskind DS, Jahan R, Nogueira RG, Jovin TG, Lutsep HL, Saver JL; SWIFT Investigators. Serial Alberta Stroke Program early CT score from baseline to 24 hours in Solitaire Flow Restoration with the Intention for Thrombectomy study: a novel surrogate end point for revascularization in acute stroke. Stroke. 2014 Mar;45(3):723-7. doi: 10.1161/STROKEAHA.113.003914. Epub 2014 Feb 13.

    PubMed 24525954

  • Saver JL, Jahan R, Levy EI, Jovin TG, Baxter B, Nogueira RG, Clark W, Budzik R, Zaidat OO; SWIFT Trialists. Solitaire flow restoration device versus the Merci Retriever in patients with acute ischaemic stroke (SWIFT): a randomised, parallel-group, non-inferiority trial. Lancet. 2012 Oct 6;380(9849):1241-9. doi: 10.1016/S0140-6736(12)61384-1. Epub 2012 Aug 26.

    PubMed 22932715

Questions about this trial

What is this clinical trial studying?

A study testing SOLITAIRE™ Device and MERCI® Device in people with Ischemic Stroke, run by Medtronic Neurovascular Clinical Affairs at 2 sites 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 8 inclusion and 15 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 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 26 Oct 2016). 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?

Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage (time frame: Immediately post treatment). The study lists 3 primary outcomes in all. 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 NCT01054560, which also lists 7 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 26 Oct 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in