Clinical Study

Sofia Aspiration System As The First Line Technique

Posted Date: Oct 18, 2022

  • Investigator: Charles Prestigiacomo
  • Specialties: Neurology, Neurosurgery, Stroke, Vascular
  • Type of Study: Device

The primary objective of Cohort I of the SOFAST study is to determine the proportion of subjects achieving successful revascularization (mTICI = 2b) with the SOFIA® Flow Plus 6F Aspiration Catheter when used in conjunction with the direct aspiration as first line treatment technique for patients with acute ischemic stroke in the anterior circulation based on collection of real-world evidence data. Secondary objectives include the evaluation of good functional outcome (defined as mRS = 2 at day 90), revascularization time and procedure related major neurological complications, also determined based on real-world evidence data collected. The objective of Cohort II of the study is to evaluate standard outcomes such as successful revascularization (mTICI = 2b), good functional outcome (defined as mRS = 2 at day 90), revascularization time and procedure related major neurological complications based on collection of real-world evidence data. Further, additional outcomes may be defined and research questions generated based on review of the collected data.

Criteria:

The Inclusion Criteria Will Consist Of Patients Aged 21-85 (Inclusive) With A Premorbid Mrs Of 1 Or Less, Nihss At Least 5 And Imaging Confirming Lvo Identified No More Than 90 Minutes Prior To Groin Puncture. Femoral Access-Based, Aspiration Thrombectomy Should Be Considered As The First Line Modality Of Treatment.

Keywords:

Thrombectomy, Stroke, Endovascular

For More Information:

Charles J. Prestigiacomo
5515741852
presticj@ucmail.uc.edu


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