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Solitaire FR Thrombectomy for Acute Revascularisation (STAR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by ev3.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
ev3 International
Information provided by (Responsible Party):
ev3
ClinicalTrials.gov Identifier:
NCT01327989
First received: October 12, 2010
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

The purpose of this observational clinical evaluation is to evaluate the safety and efficacy of the Solitaire FR Device in subjects requiring mechanical thrombectomy when used according to its Instruction For Use (IFU), in real life practice.


Condition
Stroke, Acute

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: STAR: Solitaire FR Thrombectomy for Acute Revascularisation

Further study details as provided by ev3:

Primary Outcome Measures:
  • 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 (day 1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of device-related and procedure related Serious Adverse Events (SAEs) as a measure of safety. [ Time Frame: At hospital discharge or at 10 days post procedure if patient not discharged. ] [ Designated as safety issue: Yes ]
  • Time to revascularisation [ Time Frame: Post procedure ] [ Designated as safety issue: No ]
    From groin stick to final Solitaire FR angiogram (day 1)


Enrollment: 210
Study Start Date: October 2010
Groups/Cohorts
Solitaire FR Device

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients presenting acute ischemic stroke with mechanical thrombectomy treatment deemed appropriate. Consecutive evaluation.

Criteria

Inclusion Criteria:

  • Patient or patient's legally authorized representative received information about data collection or if mandatory, has signed and dated an Informed Consent Form
  • Age ≥ 18 and < 85 years
  • Clinical signs and imaging criteria consistent with acute ischemic stroke
  • Thrombolysis in Cerebral Infarction TICI 0 or TICI 1 flow in 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 on set according to local stroke protocol
  • If stroke presentation within 4.5hours, one of these conditions can be met:

    • Bridging protocol (starting intravenous and continuing with intra-arterial) (up to maximum 0.9mg/kg)
    • Failed Intravenous thrombolysis
    • Direct Intra-Arterial treatment (according to institution guidelines)
  • Patient is willing to conduct follow-up visits
  • National Institute of Health Stroke Scale (NIHSS) ≥ 8 and ≤ 30
  • modified Rankin Scale (mRS) ≤ 2 prior to stroke onset

Exclusion Criteria:

  • 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 Institute 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 INR (International Normal Ratio) > 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
  • 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 CT with signs of hemorrhage, avm or aneurysm
  • Erly ischemic changes > 1/3 of the middle cerebral artery (MCA) territory or according to brain CT ASPECT score ≤ 6 or according to Diffusion Weighted Magnetic Resonnance Imaging (MR DWI)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327989

Locations
Switzerland
Inselspital University Hospital of Bern
Bern, Switzerland, 3010
Hôpitaux Universitaires de Genève (HUG)
Geneva, Switzerland, 1211
Sponsors and Collaborators
ev3
ev3 International
Investigators
Principal Investigator: Vitor Mendes Pereira, Dr HUG Geneva
Principal Investigator: Jan Gralla, Dr Inselspital University Hospital of Bern
  More Information

No publications provided by ev3

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ev3
ClinicalTrials.gov Identifier: NCT01327989     History of Changes
Other Study ID Numbers: ev3-02-2010
Study First Received: October 12, 2010
Last Updated: August 27, 2012
Health Authority: Switzerland: Ethikkommission
Germany: Ethics Committee
Spain: Ethics Committee

Keywords provided by ev3:
Solitaire FR Device
Mechanical Thrombectomy
Recanalization
Brain artery recanalization
Neurovascular intervention
Interventional Neuroradiology
STAR
Acute Ischemic Stroke

ClinicalTrials.gov processed this record on November 19, 2014