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SOFia Aspiration System as First Line Technique ("SOFAST")

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ClinicalTrials.gov Identifier: NCT04451525
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Microvention-Terumo, Inc.

Brief Summary:
The purpose of this study is to assess functional, imaging, and safety outcomes of the SOFIA® Flow Plus 6F Aspiration Catheter when used with the direct aspiration as first line treatment technique for the treatment of patients with acute ischemic stroke in the anterior circulation.

Condition or disease Intervention/treatment
Acute Ischemic Stroke Large Vessel Occlusion Stroke Ischemic Device: SOFIA® Flow Plus 6F Aspiration Catheter with the Gomco 405 Aspiration Pump and Tubing Kit

Detailed Description:
This is a prospective, multi-center, single arm, observational study. The primary objective is to determine proportion of subjects achieving successful revascularization with the SOFIA® Flow Plus 6F Aspiration Catheter when used in conjunction with the direct aspiration as first line treatment technique for patients with AIS.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SOFAST: SOFia Aspiration System as First Line Technique
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Group/Cohort Intervention/treatment
Patients with Acute Ischemic Stroke Device: SOFIA® Flow Plus 6F Aspiration Catheter with the Gomco 405 Aspiration Pump and Tubing Kit
The subject should be prepared for the planned interventional procedure according to standard hospital procedures. The protocol calls for mechanical revascularization using SOFIA® Flow Plus 6F Aspiration Catheter for first line treatment of clot removal




Primary Outcome Measures :
  1. Proportion of subjects achieving mTICI ≥ 2b revascularization [ Time Frame: During the procedure ]

Secondary Outcome Measures :
  1. Proportion of subjects with good functional outcome defined as mRS ≤ 2 [ Time Frame: 90 days ]
  2. Occurrence of procedure related serious adverse events [ Time Frame: During the procedure through study completion at 90 days ]
  3. Occurrence of sICH within 24 hours [ Time Frame: 24 hours Post-operative ]
  4. Occurrence of embolization to new territories (ENT) [ Time Frame: During the procedure ]


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:   21 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults presenting with AIS in the anterior circulation that can be treated using the direct aspiration as first line treatment technique for mechanical thrombectomy.
Criteria

Inclusion Criteria:

  • Patient is ≥ 21 and < 80 years of age.
  • Patient has a pre-morbid mRS ≤ 1.
  • Neuroimaging (CT/CTA and/or MR/MRA collected at no more than 60 minutes pre-treatment) demonstrates large vessel proximal occlusion (distal ICA through MCA bifurcation).
  • Patient has an NIHSS score ≥ 5 at time of intervention.
  • Symptom onset is within 6 hours of when groin puncture can be achieved.
  • Patient is appropriate for treatment via femoral access.
  • Patient is considered by the treating physician to be treatable using the direct aspiration as first line treatment technique.
  • Patient or patient's legally authorized representative (LAR) has provided written informed consent.
  • Patient is considered by the treating physician to be available for and able to complete all follow-up visits with a trained site investigator.

Exclusion Criteria:

  • Inability to obtain written informed consent.
  • Patient is < 21 or ≥ 80 years of age.
  • Patient has a pre-morbid mRS ≥ 2.
  • More than 6 hours have passed since symptom onset.
  • Severe unilateral or bilateral carotid artery stenosis or dissection requiring stent treatment.
  • Presence of a pre-existing large territory infarction.
  • Absent femoral pulses or other condition preventing femoral access.
  • Patient has vascular anatomy/tortuosity or other vascular disease preventing access to the target occlusion or that will likely result in unstable access.
  • Patient is pregnant.
  • Known or suspected pre-existing/chronic large vessel occlusion in the symptomatic territory.
  • Patient has known, untreatable hypersensitivity to contrast dye, iodine or any component of the treatment device that cannot be medically controlled.
  • The intracranial occlusion is suspected to be chronic based past imaging, clinical history, or clinical judgment.
  • Patient has a severe or life-threatening comorbidity that could confound study results, or that will render the procedure unlikely to benefit the patient.
  • Patient is unable to complete scheduled follow-up assessments due to comorbidities, geographical limitations, or a life expectancy of less than 3 months.
  • Patient is enrolled in another device or drug study in which participation could confound study results.
  • Imaging (CT or MR) exclusion criteria:

    1. Presence of intracerebral hemorrhage as evidenced on initial imaging
    2. Ischemic changes in the posterior circulation territories (including the vertebra-basilar and posterior cerebral arteries)
    3. Significant mass effect with midline shift
    4. Evidence of intracranial tumor
    5. Baseline ischemic core lesion >50 cc
    6. Involvement of > 1/3 of the middle cerebral artery territory
    7. ASPECTS <6 (hemispheric sulcal effacement and/or loss of grey-white differentiation alone are not contraindications for treatment)

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): NCT04451525


Contacts
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Contact: Chi Chau, MSHS, CCRP 714-247-8183 Chi.chau@microvention.com
Contact: Milena Tintcheva milena.tintcheva@microvention.com

Locations
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United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Ranyah Almardawi, M.B.B.S, M.P.H    410-328-5562    ranyahalmardawi@umm.edu   
Principal Investigator: Timothy Miller, MD         
Sponsors and Collaborators
Microvention-Terumo, Inc.
Investigators
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Principal Investigator: Dheeraj Gandhi, MBBS, MD University of Maryland, Baltimore
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Responsible Party: Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier: NCT04451525    
Other Study ID Numbers: CL11012
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
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
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Microvention-Terumo, Inc.:
Mechanical Thrombectomy, Aspiration, SOFIA®, Direct Aspiration
Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes