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

Stroke, Acute Clinical Trial

— SESAME  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03417349
• Other study ID #: SESAME
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: March 15, 2022

Study information

• Verified date: March 2022
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 15, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Stroke
• Cerebrovascular Stroke
• Ischemic Stroke
• Stroke
• Stroke, Acute

Intervention

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.

Locations

Country	Name	City	State
Austria	Kepler Universitätsklinikum	Linz
Austria	Salzburger Landeskliniken	Salzburg
France	Le Centre Hospitalier Universitaire de Bordeaux	Bordeaux
France	Centre Hospitalier Régional Universitaire de Lille	Lille
France	Groupe Hospitalier Universitaire Pitié Salpêtrière	Paris
France	Kremin Bicêtre- Paris Sud University	Paris
France	CHU de Toulouse Hôpital Purpan	Toulouse
Germany	Klinikum Augsburg	Augsburg
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Universitätsklinikum Knappschaftskrankenhaus Bochum	Bochum
Germany	University Hospital Heidelberg	Heidelberg	Baden-Württemberg
Germany	Universitätsklinikum des Saarlandes	Homburg
Germany	Universitätsklinikum Schleswig-Holstein	Kiel
Italy	Policlinico "G. Martino" di Messina	Messina
Netherlands	Universitair Medisch Centrum Groningen	Groningen

Sponsors (3)

Lead Sponsor	Collaborator
Dr. Markus Alfred Möhlenbruch	Eppdata Hamburg, Microvention-Terumo, Inc.

Countries where clinical trial is conducted

Austria,  France,  Germany,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety - neurological	Occurrence of major neurological events (stroke, intracranial hemorrhage, intracerebral hemorrhage, etc.)	Prior to discharge / approximated 3-7 days
Secondary	Safety - procedural	Devices and procedure related adverse events within 90 days of follow up	90 days
Secondary	ENT	Infarct in a New Territory After Treatment Administration as seen on final control angiogram at the end of the procedure	Intra-procedure
Secondary	sICH	Occurrence of symptomatic intracranial hemorrhage (sICH) within 24 hours	24 hours
Secondary	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
Secondary	Recanalization - Aspiration	Proportion of patients having complete recanalization (TICI= 2b) just after first line aspiration treatment as seen on control angiogram	Intra-procedure
Secondary	Recanalization - Other	Proportion of patients having complete recanalization (TICI = 2b) af-ter thrombectomy using an additional devices as seen on control angiogram	Intra-procedure
Secondary	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
Secondary	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
Secondary	Time to angio	Time from CT-scan/MRI at the institution to groin access	Intra-procedure
Secondary	Symptom onset	Time from symptom onset to CT-scan/MRI	Pre-procedure
Secondary	Neurological outcome 24	National Institutes of Health Stroke Scale (NIHSS) score at 24 hours, total and subscale scores	24 hours
Secondary	Neurological outcome discharge	National Institutes of Health Stroke Scale (NIHSS) score at discharge, total and subscale scores	Discharge / approximately 3-7 days
Secondary	Neurological outcome 90 days	National Institutes of Health Stroke Scale (NIHSS) score at 90 days, total and subscale scores	90 days / +/- 14 days
Secondary	Degree of disability - discharge	modified Rankin Score at discharge, total score	Discharge/ approximately 3-7 days
Secondary	Degree of disability - 90d	modified Rankin Score at 90 day follow-up, total score	90 days / +/- 14 days
Secondary	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
Secondary	Imaging	Difference of Alberta stroke program early CT score (ASPECTs) scores in CT/MRI pretreatment vs. 24h, total scores	24 hours
Secondary	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
Secondary	Health Economics -device	Device costs (standardized cost of all devices as well as human resources and medication used during index procedure)	Intra-procedure
Secondary	Health Economics - hospital	Hospital length of stay	Discharge / approximately 3-7 days