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Cerebrovascular StrokeSESAMENCT03417349

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

An observational study of Cerebrovascular Stroke and Stroke, Acute, run by Dr. Markus Alfred Möhlenbruch at 15 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sofia
Type of treatment
Medical device
How many people
250 participants
Where
15 sitesin 5 countries
Study dates
1 Oct 2017to 15 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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.)
  • 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

Trial locations and contacts

15 sites in 5 countries.

15 sites in 5 countries

Germany6 sites

  • Klinikum Augsburg

    Augsburg, 86156

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

  • Universitätsklinikum Knappschaftskrankenhaus Bochum

    Bochum, 44892

  • University Hospital Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitätsklinikum des Saarlandes

    Homburg, 66421

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24105

Other trials in Germany

France5 sites

  • Le Centre Hospitalier Universitaire de Bordeaux

    Bordeaux, 33404

  • Centre Hospitalier Régional Universitaire de Lille

    Lille, 69037

  • Groupe Hospitalier Universitaire Pitié Salpêtrière

    Paris

  • Kremin Bicêtre- Paris Sud University

    Paris

  • CHU de Toulouse Hôpital Purpan

    Toulouse, 31059

Other trials in France

Austria2 sites

  • Kepler Universitätsklinikum

    Linz, 4020

  • Salzburger Landeskliniken

    Salzburg, 5020

Other trials in Austria

Italy1 site

  • Policlinico "G. Martino" di Messina

    Messina, 98158

Other trials in Italy

Netherlands1 site

  • Universitair Medisch Centrum Groningen

    Groningen, 9713

Other trials in Netherlands

About this study

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

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.

Read the 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.

Being tested
Sofia
Keywords
Acute Ischemic Stroke, Thrombectomy, Aspiration Thrombectomy, Observational study
Medical subject headings
Stroke, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SofiaDevice

    Also called Microvention - SOFIA Catheter, Microvention - SOFIA Plus Catheter

    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.

Study groups in NCT03417349
Study groupRoleWhat they receive
Aspiration thrombectomyPatients 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
Receives: Device: Sofia

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 90 days

Secondary outcomes (21)

  1. Safety - neurological

    Occurrence of major neurological events (stroke, intracranial hemorrhage, intracerebral hemorrhage, etc.)

    Measured: Prior to discharge / approximated 3-7 days

  2. Safety - procedural

    Devices and procedure related adverse events within 90 days of follow up

    Measured: 90 days

  3. ENT

    Infarct in a New Territory After Treatment Administration as seen on final control angiogram at the end of the procedure

    Measured: Intra-procedure

  4. sICH

    Occurrence of symptomatic intracranial hemorrhage (sICH) within 24 hours

    Measured: 24 hours

  5. 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

    Measured: Intra-procedure

  6. Recanalization - Aspiration

    Proportion of patients having complete recanalization (TICI≥ 2b) just after first line aspiration treatment as seen on control angiogram

    Measured: Intra-procedure

  7. Recanalization - Other

    Proportion of patients having complete recanalization (TICI ≥ 2b) af-ter thrombectomy using an additional devices as seen on control angiogram

    Measured: Intra-procedure

  8. 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

    Measured: Intra-procedure

  9. 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

    Measured: Intra-procedure

  10. Time to angio

    Time from CT-scan/MRI at the institution to groin access

    Measured: Intra-procedure

  11. Symptom onset

    Time from symptom onset to CT-scan/MRI

    Measured: Pre-procedure

  12. Neurological outcome 24

    National Institutes of Health Stroke Scale (NIHSS) score at 24 hours, total and subscale scores

    Measured: 24 hours

  13. Neurological outcome discharge

    National Institutes of Health Stroke Scale (NIHSS) score at discharge, total and subscale scores

    Measured: Discharge / approximately 3-7 days

  14. Neurological outcome 90 days

    National Institutes of Health Stroke Scale (NIHSS) score at 90 days, total and subscale scores

    Measured: 90 days / +/- 14 days

  15. Degree of disability - discharge

    modified Rankin Score at discharge, total score

    Measured: Discharge/ approximately 3-7 days

  16. Degree of disability - 90d

    modified Rankin Score at 90 day follow-up, total score

    Measured: 90 days / +/- 14 days

  17. Quality of Life at 90 days

    Quality of Life at 90 days assessed via PROMIS Scale v1.2 - Global Health, total score

    Measured: 90 days / +/- 14 days

  18. Imaging

    Difference of Alberta stroke program early CT score (ASPECTs) scores in CT/MRI pretreatment vs. 24h, total scores

    Measured: 24 hours

  19. 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

    Measured: 24 hours

  20. Health Economics -device

    Device costs (standardized cost of all devices as well as human resources and medication used during index procedure)

    Measured: Intra-procedure

  21. Health Economics - hospital

    Hospital length of stay

    Measured: Discharge / approximately 3-7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2018
  2. Study start1 Oct 2017
  3. Primary completion31 Dec 2021
  4. Study completion15 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03417349
Sponsor's protocol ID
SESAME
Acronym
SESAME
Status last verified
Mar 2022
First submitted
16 Jan 2018
Last updated
21 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebrovascular Stroke and Stroke, Acute, run by Dr. Markus Alfred Möhlenbruch at 15 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Germany, France, Austria, Italy, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical outcome (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03417349.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022; AzTrials last refreshed its copy on 29 Oct 2026.

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