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

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ClinicalTrials.gov Identifier: NCT03417349
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : December 20, 2018
Sponsor:
Collaborators:
Microvention-Terumo, Inc.
Eppdata Hamburg
Information provided by (Responsible Party):
Dr. Markus Alfred Möhlenbruch, University Hospital Heidelberg

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.


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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : May 30, 2020

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417349


Contacts
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Contact: Susanne Bonekamp, DVM +4962215635710 susanne.bonekamp@med.uni-heidelberg.de
Contact: Lukas Diebold +4962215638346 lukas.diebold@med.uni-heidelberg.de

Locations
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Austria
Kepler Universitätsklinikum Not yet recruiting
Linz, Austria, 4020
Contact: Johannes Trenkler, MD       johannes.trenkler@kepleruniklinikum.at   
Contact: Elke Bach       Elke.Bach@kepleruniklinikum.at   
Salzburger Landeskliniken Recruiting
Salzburg, Austria, 5020
Contact: Monika Killer-Oberpfalzer, MD       m.killer@salk.at   
Contact: Angela Jedlitschka       a.jedlitschka@salk.at   
France
Le Centre Hospitalier Universitaire de Bordeaux Not yet recruiting
Bordeaux, France, 33404
Contact: Xavier Barreau, MD       xavier.barreau@chu-bordeaux.fr;   
CHU Henri Mondor Not yet recruiting
Créteil, France, 94010
Contact: Titien Tuilier, MD       titien.tuilier@aphp.fr   
Centre Hospitalier Régional Universitaire de Lille Not yet recruiting
Lille, France, 69037
Contact: Laurent Esstrade, MD       laurentestrade@gmail.com   
CHU de Toulouse Hôpital Purpan Not yet recruiting
Toulouse, France, 31059
Contact: Christophe Cognard, MD       cognard.c@chu-toulouse.fr   
Contact: Anne-Christine Januel, MD       januel.ac@chu-toulouse.fr   
Germany
University Hospital Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Markus A Möhlenbruch, MD       markus.moehlenbruch@med.uni-heidelberg.de   
Contact: Lukas Diebold       lukas.diebold@med.uni-heidelberg.de   
Klinikum Augsburg Recruiting
Augsburg, Germany, 86156
Contact: Ansgar Berlis, MD       ansgar.berlis@klinikum-augsburg.de   
Contact: Ilse Kummer       Ilse.Kummer@klinikum-augsburg.de   
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Georg Bohner, MD       georg.bohner@charite.de   
Contact: Annett Schreck       annett.schreck@charite.de   
Universitätsklinikum Knappschaftskrankenhaus Bochum Recruiting
Bochum, Germany, 44892
Contact: Sebastian Fischer, MD       sebastian.fischer@kk-bochum.de   
Contact: Werner Weber, MD       werner.weber@kk-bochum.de   
Universitätsklinikum des Saarlandes Recruiting
Homburg, Germany, 66421
Contact: Wolfgang Reith, MD       wolfgang.reith@uks.eu   
Universitätsklinikum Schleswig-Holstein Not yet recruiting
Kiel, Germany, 24105
Contact: Fritz Wodarg, MD       fritz.wodarg@uksh.de   
Contact: Sabine Krieter, MA       sabine.krieter@uksh.de   
Netherlands
Universitair Medisch Centrum Groningen Not yet recruiting
Groningen, Netherlands, 9713
Contact: Reinoud Bokkers, MD       r.p.h.bokkers@umcg.nl   
Sponsors and Collaborators
Dr. Markus Alfred Möhlenbruch
Microvention-Terumo, Inc.
Eppdata Hamburg
Investigators
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Principal Investigator: Markus A Möhlenbruch, MD University Hospital Heidelberg

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Responsible Party: Dr. Markus Alfred Möhlenbruch, Principle Investigator, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT03417349     History of Changes
Other Study ID Numbers: SESAME
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases