Clinical trial NCT03417349: Safety and Effectiveness of SOFIA™/SOFIA™ PLUS for Direct Aspiration in Acute Ischemic Stroke
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebrovascular Stroke
Stroke, Acute
Cerebral Stroke
Keywords: Acute Ischemic Stroke
Thrombectomy
Aspiration Thrombectomy
Observational study
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: Microvention-Terumo, Inc.
name: Eppdata Hamburg
First posted: 2018-01-31
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility 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

Primary outcomes:
measure: Clinical outcome
timeFrame: 90 days
Secondary outcomes:
measure: Safety - neurological
timeFrame: Prior to discharge / approximated 3-7 days
measure: Safety - procedural
timeFrame: 90 days
measure: ENT
timeFrame: Intra-procedure
measure: sICH
timeFrame: 24 hours
measure: Vessel damage
timeFrame: Intra-procedure
measure: Recanalization - Aspiration
timeFrame: Intra-procedure
measure: Recanalization - Other
timeFrame: Intra-procedure
measure: Time to recanalization- Aspiration
timeFrame: Intra-procedure
measure: Time to recanalization- Other
timeFrame: Intra-procedure
measure: Time to angio
timeFrame: Intra-procedure
measure: Symptom onset
timeFrame: Pre-procedure
measure: Neurological outcome 24
timeFrame: 24 hours
measure: Neurological outcome discharge
timeFrame: Discharge / approximately 3-7 days
measure: Neurological outcome 90 days
timeFrame: 90 days / +/- 14 days
measure: Degree of disability - discharge
timeFrame: Discharge/ approximately 3-7 days
measure: Degree of disability - 90d
timeFrame: 90 days / +/- 14 days
measure: Quality of Life at 90 days
timeFrame: 90 days / +/- 14 days
measure: Imaging
timeFrame: 24 hours
measure: Imaging - perfusion
timeFrame: 24 hours
measure: Health Economics -device
timeFrame: Intra-procedure
measure: Health Economics - hospital
timeFrame: Discharge / approximately 3-7 days
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler Universitätsklinikum
city: Salzburg
country: Austria
facility: Salzburger Landeskliniken
city: Bordeaux
country: France
facility: Le Centre Hospitalier Universitaire de Bordeaux
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille
city: Paris
country: France
facility: Groupe Hospitalier Universitaire Pitié Salpêtrière
city: Paris
country: France
facility: Kremin Bicêtre- Paris Sud University
city: Toulouse
country: France
facility: CHU de Toulouse Hôpital Purpan
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Bochum
country: Germany
facility: Universitätsklinikum Knappschaftskrankenhaus Bochum
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Messina
country: Italy
facility: Policlinico "G. Martino" di Messina
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
Study officials:
affiliation: University Hospital Heidelberg
name: Markus A Möhlenbruch, MD
role: PRINCIPAL_INVESTIGATOR
References: