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Safety and Effectiveness of SOFIA™/SOFIA™ PLUS for Direct Aspiration in Acute Ischemic Stroke

NCT03417349 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2022-03-21

No results posted yet for this study

Summary

Sesame is a European, multi-center, single arm, prospective, observational registry.

Sesame aims to demonstrate that use of SOFIA™/SOFIA™ PLUS catheter for direct aspiration as a first line treatment technique is fast, safe and effective in patients suffering an Acute Ischemic Stroke when assessed at 24 hours, discharge and 90 days after treatment. 250 patients will be enrolled. All patients will be followed for 90 days or until death.

Conditions

  • Cerebrovascular Stroke
  • Stroke, Acute
  • Cerebral Stroke

Interventions

DEVICE

Sofia

The SOFIA™/ SOFIA™ PLUS Catheter will be used in removal/aspiration of emboli and thrombi following the CE marked Instructions For Use. Enrollment into the study does not change the routine care at the site provided to the patient requiring mechanical thrombectomy treatment.

Sponsors & Collaborators

  • Microvention-Terumo, Inc.

    collaborator INDUSTRY

  • Eppdata Hamburg

    collaborator UNKNOWN

  • Dr. Markus Alfred Möhlenbruch

    lead OTHER

Principal Investigators

  • Markus A Möhlenbruch, MD · University Hospital Heidelberg

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2021-12-31
Completion
2022-03-15
FDA Device
Yes

Countries

  • Austria
  • France
  • Germany
  • Italy
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03417349 on ClinicalTrials.gov