Status:
COMPLETED
Safety and Effectiveness of SOFIA™/SOFIA™ PLUS for Direct Aspiration in Acute Ischemic Stroke
Lead Sponsor:
Dr. Markus Alfred Möhlenbruch
Collaborating Sponsors:
Microvention-Terumo, Inc.
Eppdata Hamburg
Conditions:
Cerebrovascular Stroke
Stroke, Acute
Eligibility:
All Genders
18+ years
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...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 15 2022
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03417349
Start Date
October 1 2017
End Date
March 15 2022
Last Update
March 21 2022
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Kepler Universitätsklinikum
Linz, Austria, 4020
2
Salzburger Landeskliniken
Salzburg, Austria, 5020
3
Le Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France, 33404
4
Centre Hospitalier Régional Universitaire de Lille
Lille, France, 69037