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

NCT03417349 | Completed FDA Device

• 1 other identifier: SESAME
• Study Type: observational
• Target: 250
• Locations: 5 countries
• Sites: 15

Brief 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

Keywords

Acute Ischemic Stroke; Thrombectomy; Aspiration Thrombectomy; Observational study

Outcome Measures

Primary Outcomes (1)

• Clinical outcome

  Dichotomization of patients into good functional outcome defined as a modified Rankin Score (mRS) ≤ 2 and bad functional outcome defined as mRS \>2

  90 days

Secondary Outcomes (21)

• Safety - neurological

  Prior to discharge / approximated 3-7 days

• Safety - procedural

  90 days

• ENT

  Intra-procedure

• sICH

  24 hours

• Vessel damage

  Intra-procedure

Study Arms (1)

Aspiration thrombectomy

Patients with acute ischemic stroke of the anterior circulation whom the treating physician deemed eligible to be treated with SOFIA™/ SOFIA™ as a first line treatment technique

Device: Sofia

Interventions

Sofia DEVICE

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.

Also known as: Microvention - SOFIA Catheter, Microvention - SOFIA Plus Catheter

Aspiration thrombectomy

Eligibility Criteria

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

Study Population

Patients who are at least 18 years of age presenting with an acute ischemic event in the anterior cerebral circulation that can be treated within 6 hours from AIS symptom onset. Those eligible to be treated with SOFIA™/ SOFIA™ PLUS will be enrolled after having signed an informed consent form (or having one signed on his or her behalf by a legally authorized representative).

You may qualify if:

• Participant is ≥ 18
• Demonstrated occlusion of the distal intracranial carotid artery, middle cerebral artery (M1 or M2) or anterior cerebral artery (A1 or A2) proven by CT and/or MRI
• NIHSS ≥ 2 and ≤ 30 at screening
• Start of the thrombectomy procedure within 6 hours of the onset of stroke symptoms
• Pre event mRS ≤1
• Patient or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form

You may not qualify if:

• Patient is more than 6 hours from symptom onset
• Rapidly improving neurologic examination
• Evidence of cerebral ischemia in the posterior circulation
• Severe unilateral or bilateral carotid artery stenosis requiring stent treatment
• Presence of an existing or pre-existing large territory infarction
• Absent femoral pulses
• Excessive vascular tortuosity that will likely result in unstable access
• Pregnancy; if a woman is of child-bearing potential a urine or serum beta HCG test is positive
• Known contrast product allergy
• Patient has a severe or fatal comorbidity that will likely prevent improvement or follow up or that will render the procedure unlikely to benefit the patient
• Evidence of intracranial hemorrhage (SAH, ICH, etc.)
• Significant mass effect with midline shift or intracranial tumor
• Baseline non-contrast CT or DWI MRI evidence of a moderate/large core defined as extensive early ischemic changes of Alberta Stroke Program Early CT score (ASPECTS) 0-5

Sponsors & Collaborators

• Dr. Markus Alfred Möhlenbruch: lead
• Microvention-Terumo, Inc.: collaborator
• Eppdata Hamburg: collaborator

Study Sites (15)

Kepler Universitätsklinikum

Linz, 4020, Austria

Location

Salzburger Landeskliniken

Salzburg, 5020, Austria

Location

Le Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33404, France

Location

Centre Hospitalier Régional Universitaire de Lille

Lille, 69037, France

Location

Groupe Hospitalier Universitaire Pitié Salpêtrière

Paris, France

Location

Kremin Bicêtre- Paris Sud University

Paris, France

Location

CHU de Toulouse Hôpital Purpan

Toulouse, 31059, France

Location

University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Klinikum Augsburg

Augsburg, 86156, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Universitätsklinikum Knappschaftskrankenhaus Bochum

Bochum, 44892, Germany

Location

Universitätsklinikum des Saarlandes

Homburg, 66421, Germany

Location

Universitätsklinikum Schleswig-Holstein

Kiel, 24105, Germany

Location

Policlinico "G. Martino" di Messina

Messina, 98158, Italy

Location

Universitair Medisch Centrum Groningen

Groningen, 9713, Netherlands

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

Catheters

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Markus A Möhlenbruch, MD

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: January 31, 2018
• Study Start: October 1, 2017
• Primary Completion: December 31, 2021
• Study Completion: March 15, 2022
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

FR (5); AU (2); IT (1); NL (1); DE (6)