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

• ClinicalTrials.gov Identifier: NCT03417349
• Recruitment Status: Completed
• First Posted: January 31, 2018
• Last Update Posted: March 21, 2022
• Sponsor: Dr. Markus Alfred Möhlenbruch
• Collaborators: Microvention-Terumo, Inc.; Eppdata Hamburg
• Information provided by (Responsible Party): Dr. Markus Alfred Möhlenbruch, University Hospital Heidelberg

Study Description

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.

Condition or disease	Intervention/treatment
Cerebrovascular Stroke; Stroke, Acute; Cerebral Stroke	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 Design

• Study Type: Observational
• Actual Enrollment: 250 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 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
• Actual Study Start Date: October 1, 2017
• Actual Primary Completion Date: December 31, 2021
• Actual Study Completion Date: March 15, 2022

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Clinical outcome [ Time Frame: 90 days ]
   Dichotomization of patients into good functional outcome defined as a modified Rankin Score (mRS) ≤ 2 and bad functional outcome defined as mRS >2

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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).

Criteria

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

Contacts and Locations

Locations

Austria

Kepler Universitätsklinikum

Linz, Austria, 4020

Salzburger Landeskliniken

Salzburg, Austria, 5020

France

Le Centre Hospitalier Universitaire de Bordeaux

Bordeaux, France, 33404

Centre Hospitalier Régional Universitaire de Lille

Lille, France, 69037

Groupe Hospitalier Universitaire Pitié Salpêtrière

Paris, France

Kremin Bicêtre- Paris Sud University

Paris, France

CHU de Toulouse Hôpital Purpan

Toulouse, France, 31059

Germany

University Hospital Heidelberg

Heidelberg, Baden-Württemberg, Germany, 69120

Klinikum Augsburg

Augsburg, Germany, 86156

Charité - Universitätsmedizin Berlin

Berlin, Germany, 10117

Universitätsklinikum Knappschaftskrankenhaus Bochum

Bochum, Germany, 44892

Universitätsklinikum des Saarlandes

Homburg, Germany, 66421

Universitätsklinikum Schleswig-Holstein

Kiel, Germany, 24105

Italy

Policlinico "G. Martino" di Messina

Messina, Italy, 98158

Netherlands

Universitair Medisch Centrum Groningen

Groningen, Netherlands, 9713

Sponsors and Collaborators

Dr. Markus Alfred Möhlenbruch

Microvention-Terumo, Inc.

Eppdata Hamburg

Investigators

• Principal Investigator: Markus A Möhlenbruch, MD; University Hospital Heidelberg

More Information

• Responsible Party: Dr. Markus Alfred Möhlenbruch, Principle Investigator, University Hospital Heidelberg
• ClinicalTrials.gov Identifier: NCT03417349
• Other Study ID Numbers: SESAME
• First Posted: January 31, 2018
• Last Update Posted: March 21, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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

Keywords provided by Dr. Markus Alfred Möhlenbruch, University Hospital Heidelberg:

Acute Ischemic Stroke; Thrombectomy; Aspiration Thrombectomy; Observational study

Additional relevant MeSH terms:

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