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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.

Tracking Information
First Submitted Date June 24, 2020
First Posted Date June 30, 2020
Last Update Posted Date June 30, 2020
Estimated Study Start Date June 2020
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 26, 2020)
Proportion of subjects achieving mTICI ≥ 2b revascularization [ Time Frame: During the procedure ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 26, 2020)
  • Proportion of subjects with good functional outcome defined as mRS ≤ 2 [ Time Frame: 90 days ]
  • Occurrence of procedure related serious adverse events [ Time Frame: During the procedure through study completion at 90 days ]
  • Occurrence of sICH within 24 hours [ Time Frame: 24 hours Post-operative ]
  • Occurrence of embolization to new territories (ENT) [ Time Frame: During the procedure ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title SOFia Aspiration System as First Line Technique
Official Title SOFAST: SOFia Aspiration System as First Line Technique
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Acute Ischemic Stroke
  • Large Vessel Occlusion
  • Stroke
  • Ischemic
Intervention 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
Study Groups/Cohorts Patients with Acute Ischemic Stroke
Intervention: Device: SOFIA® Flow Plus 6F Aspiration Catheter with the Gomco 405 Aspiration Pump and Tubing Kit
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 26, 2020)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Chi Chau, MSHS, CCRP 714-247-8183 Chi.chau@microvention.com
Contact: Milena Tintcheva milena.tintcheva@microvention.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04451525
Other Study ID Numbers CL11012
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Microvention-Terumo, Inc.
Study Sponsor Microvention-Terumo, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Dheeraj Gandhi, MBBS, MD University of Maryland, Baltimore
PRS Account Microvention-Terumo, Inc.
Verification Date June 2020