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

Safety and Effectiveness of SOFIA™/SOFIA™ PLUS When Used for Direct Aspiration as a First Line Treatment Technique in Patients Suffering an Acute Ischemic Stroke in the Anterior Circulation

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Acute; Cerebral Stroke; Cerebrovascular Stroke
• Intervention / Treatment: Device: Sofia

Detailed Description

Several publications describing the use of aspiration as a first line treatment technique in AIS patients have shown superior technical results with similar clinical outcomes to those seen when using a traditional stent retriever. They have also shown decreased procedure time and cost. The aim of this study is to show similar results in terms of speed, Effectiveness and safety when SOFIA™/ SOFIA™ PLUS is the catheter used for first line aspiration thrombectomy.

The SOFIA™ (Soft Torqueable Catheter Optimized For Intracranial Access) and SOFIA™ PLUS Catheter are single lumen, flexible catheters, designed with coil and braid reinforcement. The SOFIA™ / SOFIA™ PLUS catheters have a soft distal tip for easy navigation in tortuous vessels. The tip is steam shapable and the proximal shaft torquable to help steer around challenging bifurcations. The coil and braid construction provides enhanced kink resistance and 1:1 push / pull control. Once navigated to the site of the occlusion, the SOFIA™ / SOFIA™ PLUS catheters can be used in conjunction with an aspiration source, such as a pump or syringe, to facilitate aspiration thrombectomy of the occluded vessel. The SOFIA™ / SOFIA™ PLUS catheters have large lumens, developed to maximize aspiration power and capture of thrombus.

SESAME is a multi-center, single arm, prospective, observational registry of the SOFIA™/ SOFIA™ PLUS Catheter in Europe. Consecutive patients presenting within 6 hours of symptom onset with an anterior circulation large vessel occlusion (LVO) acute ischemic stroke (within the internal carotid artery and internal carotid terminus, middle cerebral -M1/M2 segments) will be treated using aspiration thrombectomy as first intention and site routine practice. Devices received CE-mark and will be used according to the 'Instructions For Use'.

The follow-up visits will occur at 24 +/- 12 hours, at patient discharge, and 90+/-14 days post-procedure.

Furthermore the study design is adaptive, prospectively stating interim analyses with specified stopping rules, which allow for the possibility of the study to terminate early based on either a determination of study success or of the futility to continue further enrollment.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria, 4020
    • Kepler Universitätsklinikum
  • Salzburg, Austria, 5020
    • Salzburger Landeskliniken
• France
  • Bordeaux, France, 33404
    • Le Centre Hospitalier Universitaire de Bordeaux
  • Lille, France, 69037
    • Centre Hospitalier Regional Universitaire de Lille
  • Paris, France
    • Groupe Hospitalier Universitaire Pitié Salpêtrière
  • Paris, France
    • Kremin Bicêtre- Paris Sud University
  • Toulouse, France, 31059
    • CHU de Toulouse Hopital PURPAN
• Germany
  • Augsburg, Germany, 86156
    • Klinikum Augsburg
  • Berlin, Germany, 10117
    • Charite - Universitatsmedizin Berlin
  • Bochum, Germany, 44892
    • Universitätsklinikum Knappschaftskrankenhaus Bochum
  • Homburg, Germany, 66421
    • Universitätsklinikum des Saarlandes
  • Kiel, Germany, 24105
    • Universitatsklinikum Schleswig-Holstein
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69120
      • University Hospital Heidelberg
• Italy
  • Messina, Italy, 98158
    • Policlinico "G. Martino" di Messina
• Netherlands
  • Groningen, Netherlands, 9713
    • Universitair Medisch Centrum Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

Inclusion Criteria:

1. Participant is ≥ 18
2. 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
3. NIHSS ≥ 2 and ≤ 30 at screening
4. Start of the thrombectomy procedure within 6 hours of the onset of stroke symptoms
5. Pre event mRS ≤1
6. Patient or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form

Exclusion Criteria:

1. Patient is more than 6 hours from symptom onset
2. Rapidly improving neurologic examination
3. Evidence of cerebral ischemia in the posterior circulation
4. Severe unilateral or bilateral carotid artery stenosis requiring stent treatment
5. Presence of an existing or pre-existing large territory infarction
6. Absent femoral pulses
7. Excessive vascular tortuosity that will likely result in unstable access
8. Pregnancy; if a woman is of child-bearing potential a urine or serum beta HCG test is positive
9. Known contrast product allergy
10. 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
11. Evidence of intracranial hemorrhage (SAH, ICH, etc.)

Imaging exclusion criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.; Other Names: Microvention - SOFIA Catheter; Microvention - SOFIA Plus Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - neurological	Occurrence of major neurological events (stroke, intracranial hemorrhage, intracerebral hemorrhage, etc.)	Prior to discharge / approximated 3-7 days
Safety - procedural	Devices and procedure related adverse events within 90 days of follow up	90 days
ENT	Infarct in a New Territory After Treatment Administration as seen on final control angiogram at the end of the procedure	Intra-procedure
sICH	Occurrence of symptomatic intracranial hemorrhage (sICH) within 24 hours	24 hours
Vessel damage	Occurrence of intracranial vessel damage at the end of the procedure as seen on final control angiogram at the end of the procedure	Intra-procedure
Recanalization - Aspiration	Proportion of patients having complete recanalization (TICI≥ 2b) just after first line aspiration treatment as seen on control angiogram	Intra-procedure
Recanalization - Other	Proportion of patients having complete recanalization (TICI ≥ 2b) af-ter thrombectomy using an additional devices as seen on control angiogram	Intra-procedure
Time to recanalization- Aspiration	Time from groin puncture to complete recanalization (TICI ≥ 2b) in patients after first line aspiration treatment as seen on control angiogram	Intra-procedure
Time to recanalization- Other	Time from groin puncture to complete recanalization (TICI ≥ 2b) in patients after thrombectomy using an additional device as seen on control angiogram	Intra-procedure
Time to angio	Time from CT-scan/MRI at the institution to groin access	Intra-procedure
Symptom onset	Time from symptom onset to CT-scan/MRI	Pre-procedure
Neurological outcome 24	National Institutes of Health Stroke Scale (NIHSS) score at 24 hours, total and subscale scores	24 hours
Neurological outcome discharge	National Institutes of Health Stroke Scale (NIHSS) score at discharge, total and subscale scores	Discharge / approximately 3-7 days
Neurological outcome 90 days	National Institutes of Health Stroke Scale (NIHSS) score at 90 days, total and subscale scores	90 days / +/- 14 days
Degree of disability - discharge	modified Rankin Score at discharge, total score	Discharge/ approximately 3-7 days
Degree of disability - 90d	modified Rankin Score at 90 day follow-up, total score	90 days / +/- 14 days
Quality of Life at 90 days	Quality of Life at 90 days assessed via PROMIS Scale v1.2 - Global Health, total score	90 days / +/- 14 days
Imaging	Difference of Alberta stroke program early CT score (ASPECTs) scores in CT/MRI pretreatment vs. 24h, total scores	24 hours
Imaging - perfusion	In the subgroup of patients with additional perfusion CT (as per local standard of care): volume of saved brain tissue determined by predictive modeling	24 hours
Health Economics -device	Device costs (standardized cost of all devices as well as human resources and medication used during index procedure)	Intra-procedure
Health Economics - hospital	Hospital length of stay	Discharge / approximately 3-7 days

Collaborators and Investigators

• Sponsor: Dr. Markus Alfred Möhlenbruch
• Collaborators: Microvention-Terumo, Inc.; Eppdata Hamburg
• Investigators: Principal Investigator: Markus A Möhlenbruch, MD, University Hospital Heidelberg

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): March 15, 2022

Study Registration Dates

• First Submitted: January 16, 2018
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 31, 2018

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Thrombectomy; Observational study; Acute Ischemic Stroke; Aspiration Thrombectomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: SESAME

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes