Solitaire FR Thrombectomy for Acute Revascularisation

NCT01327989 | Completed Results DMC

• 1 other identifier: ev3-02-2010
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Stroke, Acute

Keywords

Solitaire FR Device; Mechanical Thrombectomy; Recanalization; Brain artery recanalization; Neurovascular intervention; Interventional Neuroradiology; STAR; Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• 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

  Immediately post procedure

• 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.

  90 Days

Secondary Outcomes (7)

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

  During procedure

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

  During Procedure

• Good Neurological Condition

  90 Days

• Rate of Morbidity

  90 Days

• Rate of Mortality

  90 Days

Study Arms (1)

Solitaire™ FR device

Eligible subjects treated with the Solitaire™ FR device.

Device: Solitaire™ FR device

Interventions

Solitaire™ FR device DEVICE

Mechanical Thrombectomy

Solitaire™ FR device

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Medtronic Neurovascular Clinical Affairs: lead
• ev3 International: collaborator

Study Sites (2)

Inselspital University Hospital of Bern

Bern, 3010, Switzerland

Location

Hôpitaux Universitaires de Genève (HUG)

Geneva, 1211, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 31239326 DERIVED

• 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.

  PMID: 28097310 DERIVED

• 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.

  PMID: 24876244 DERIVED

• 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.

  PMID: 24557701 DERIVED

• 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.

  PMID: 23908066 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Manish Gupta, Sr. Director of Medical Affairs
• Organization: Medtronic

manish.gupta@medtronic.com

949-837-3700

Study Officials

• Vitor Mendes Pereira, Dr

  HUG Geneva

  PRINCIPAL INVESTIGATOR

• Jan Gralla, Dr

  Inselspital University Hospital of Bern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: April 4, 2011
• Study Start: October 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: January 1, 2013
• Last Updated: January 27, 2017
• Results First Posted: January 27, 2017

Record last verified: 2016-10

Locations

CH (2)