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Stroke, AcuteSTARNCT01327989

Solitaire FR Thrombectomy for Acute Revascularisation

An observational study of Stroke, Acute, run by Medtronic Neurovascular Clinical Affairs at 2 sites in Switzerland.

Completed

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

Official record
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Trial summary

The objective of this study was to obtain prospective clinical data on the safety and efficacy of the Solitaire™ FR device for patients diagnosed with acute ischemic stroke. Read more about this study

Who is it for?
Ages 18 to 84 years
Conditions the study is for
Stroke, Acute
What is being tested?
Solitaire™ FR device
Type of treatment
Medical device
How many people
202 participants
Where
2 sitesSwitzerland
Study dates
Oct 2010to Jan 2013
Phase
Observational
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 84 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Subjects having clinical signs and imaging criteria consistent with acute ischemic stroke who presented within 8 hours of stroke symptoms onset with the study device were considered for inclusion in the study.

Who may be able to join

  • Subject or subject's legally authorized representative has signed and dated an Informed Consent Form
  • Age ≥ 18 and < 85
  • Clinical signs consistent with acute ischemic stroke
  • Thrombolysis in Cerebral Infarction (TICI) 0 or TICI 1 flow in the proximal anterior intracranial vasculature (M1 or M2 of Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA) intracranial, Internal Carotid Artery (ICA) terminal)
  • Presentation within 8 hours of stroke onset according to local stroke protocol
  • If stroke presentation within 4.5 hours, one of these conditions can be met:
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  • Bridging protocol (starting intravenous and continuing with intra-arterial) (Up to maximum 0.9 mg/kg)
  • Failed intravenous thrombolysis
  • Direct Intra-arterial treatment (according to institution guidelines)
  • Subject is willing to conduct follow-up visits.
  • National Institutes of Health Stroke Scale (NIHSS) ≥ 8 and ≤ 30
  • Modified Rankin Scale (mRS) ≤ 2 prior to stroke onset

Who cannot join

  • Females who are pregnant or lactating
  • Known serious sensitivity to radiographic contrast agents
  • Neurological signs that are rapidly improving prior to or at time of treatment
  • Current participation in another investigational drug or device study
  • Life expectancy of less than 90 days
  • National Institutes of Health Stroke Scale (NIHSS) > 30 or coma
Show all 21Show fewer
  • Uncontrolled hypertension defined as systolic blood pressure > 185 or diastolic blood pressure > 110 that cannot be controlled except with continuous parenteral antihypertensive medication
  • Use of warfarin anticoagulation with International Normalised Ratio (INR) > 3.0
  • Platelet count < 30,000
  • Glucose < 400 mg/dL
  • Previous stroke within 30 days
  • Time of symptom onset unknown
  • Seizure at the onset of stroke
  • Myocardial infarction or infection (sepsis or endocarditis)
  • Arterial tortuosity that would prevent the device from reaching the target vessel
  • Known hypersensitivity to nickel-titanium
  • Imaging Exclusion Criteria:
  • Angiographic evidence of carotid dissection, complete cervical carotid occlusions, or vasculitis
  • Stenosis proximal to thrombus site that may preclude safe recovery of the device
  • Brain computed tomography (CT) with signs of hemorrhage, arteriovenous venous malformations, or aneurysm
  • Early ischemic changes greater than 1/3 of the middle cerebral artery (MCA) territory or according to brain computed tomography (CT) Alberta Stroke Program Early CT (ASPECT) score ≤ 6 or according to magnetic resonance diffusion weighted imaging (MR DWI) ASPECT score <5

Trial locations and contacts

2 sites in 1 country.

Switzerland2 sites

  • Inselspital University Hospital of Bern

    Bern, 3010

  • Hôpitaux Universitaires de Genève (HUG)

    Geneva, 1211

Other trials in Switzerland

About this study

Official title: STAR: Solitaire FR Thrombectomy for Acute Revascularisation

The objective of this study was to obtain prospective clinical data on the safety and efficacy of the Solitaire™ FR device for patients diagnosed with acute ischemic stroke.

Read the detailed description

The Study was a multi-center, single-arm, prospective, observational evaluation. The Solitaire™ FR Device has been certified for CE mark. This protocol evaluated the safety and efficacy of the Solitaire™ FR Device when used in routine practice and according to its Instructions for Use.

Conditions
Stroke, Acute
Being tested
Solitaire™ FR device
Keywords
Solitaire FR Device, Mechanical Thrombectomy, Recanalization, Brain artery recanalization, Neurovascular intervention, Interventional Neuroradiology, STAR, Acute Ischemic Stroke
Medical subject headings
Stroke, Ischemic Stroke

What participants receive

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

  • Solitaire™ FR deviceDevice

    Mechanical Thrombectomy

Study groups in NCT01327989
Study groupRoleWhat they receive
Solitaire™ FR deviceEligible subjects treated with the Solitaire™ FR device.
Receives: Device: Solitaire™ FR device

What is being measured

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

  1. Arterial Recanalization of the Occluded Target Vessel Measured by Thrombolysis in Cerebral Infarction (TICI) Score Equal or Superior to 2b Following the Use of the Study Device.

    Thrombolysis in Cerebral Infarction (TICI) score

    Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion

    Measured: Immediately post procedure

  2. Incidence of Device-related and Procedure-related Serious Adverse Events (SAEs).

    Device-related and procedure-related Serious Adverse Events (SAEs). A clinically significant procedure complication is defined as a decline in NIHSS of ≥4 or access vessel complication requiring surgery or blood transfusion.

    Measured: 90 Days

Secondary outcomes (7)

  1. Time to Achieve Revascularization - Groin Stick to Initial Angiogram and Final Solitaire™ FR Angiogram

    Time from groin stick to initial angiogram and final Solitaire™ FR angiogram with Thrombolysis in Cerebral Infarction (TICI) score 2b or 3 flow

    Thrombolysis in Cerebral Infarction (TICI) score

    Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion

    Measured: During procedure

  2. Time to Achieve Revascularization - After First Ipsilateral Angiogram to Final Solitaire™ FR Angiogram

    Time after first ipsilateral angiogram to final Solitaire™ FR angiogram with Thrombolysis in Cerebral Infarction (TICI) score 2b or 3 flow

    Thrombolysis in Cerebral Infarction (TICI) score

    Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion

    Measured: During Procedure

  3. Good Neurological Condition

    Good neurological outcome (GNO), as defined in the protocol, is a modified Rankin Scale (mRS) score of less than or equal to 2, or National Institutes of Health Stroke Scale (NIHSS) score 0-1, or NIHSS score improvement of 10 points or more from the pre-procedure evaluation

    Measured: 90 Days

  4. Rate of Morbidity

    Measured: 90 Days

  5. Rate of Mortality

    Measured: 90 Days

  6. Incidence of Symptomatic Intracranial Hemorrhage

    Symptomatic intracranial hemorrhage, 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 decline in National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24 hrs.

    PH1 - Hematoma within ischemic field with some mild space occupying effect but involving ≤ 30% PH2 - Hematoma within ischemic field with space-occupying effect involving > 30% of the infarcted area RIH - Any intraparenchymal hemorrhage remote from the ischemic field IVH - Intraventricular hemorrhage SAH - Subarachnoid hemorrhage

    Measured: 24 hours

  7. Immediate Flow Reperfusion

    Immediate reperfusion observed when the Solitaire™ FR device is deployed within the thrombus - Thrombolysis in Cerebral Infarction (TICI) score 2b or 3.

    Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion

    Measured: procedure

Timeline

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

  1. First posted4 Apr 2011 (estimated)
  2. Study startOct 2010
  3. Primary completionOct 2012
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01327989
Sponsor's protocol ID
ev3-02-2010
Acronym
STAR
Status last verified
Oct 2016
First submitted
12 Oct 2010
Last updated
27 Jan 2017
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

  • Menon BK, Almekhlafi MA, Pereira VM, Gralla J, Bonafe A, Davalos A, Chapot R, Goyal M; STAR Study Investigators. Optimal workflow and process-based performance measures for endovascular therapy in acute ischemic stroke: analysis of the Solitaire FR thrombectomy for acute revascularization study. Stroke. 2014 Jul;45(7):2024-9. doi: 10.1161/STROKEAHA.114.005050. Epub 2014 May 15.

    PubMed 24876244

  • Almekhlafi MA, Davalos A, Bonafe A, Chapot R, Gralla J, Pereira VM, Goyal M; STAR Registry Investigators. Impact of age and baseline NIHSS scores on clinical outcomes in the mechanical thrombectomy using solitaire FR in acute ischemic stroke study. AJNR Am J Neuroradiol. 2014 Jul;35(7):1337-40. doi: 10.3174/ajnr.A3855. Epub 2014 Feb 20.

    PubMed 24557701

  • Pereira VM, Gralla J, Davalos A, Bonafe A, Castano C, Chapot R, Liebeskind DS, Nogueira RG, Arnold M, Sztajzel R, Liebig T, Goyal M, Besselmann M, Moreno A, Moreno A, Schroth G; the STAR Investigators. Prospective, multicenter, single-arm study of mechanical thrombectomy using Solitaire Flow Restoration in acute ischemic stroke. Stroke. 2013 Oct;44(10):2802-7. doi: 10.1161/STROKEAHA.113.001232. Epub 2013 Aug 1.

    PubMed 23908066

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, Acute, run by Medtronic Neurovascular Clinical Affairs at 2 sites in Switzerland.

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 12 inclusion and 21 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 27 Jan 2017. 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 Switzerland. 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 27 Jan 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?

Arterial Recanalization of the Occluded Target Vessel Measured by Thrombolysis in Cerebral Infarction (TICI) Score Equal or Superior to 2b Following the Use of the Study Device. (time frame: Immediately post procedure). The study lists 2 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 NCT01327989, which also lists 5 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 27 Jan 2017.

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Solitaire FR Thrombectomy for Acute Revascularisation | AzTrials