"SOFAST": SOFIA Aspiration System as First Line Technique
Study Details
Study Description
Brief Summary
To collect real-world evidence allowing assessment of functional, imaging, and safety outcomes of MicroVention acute ischemic stroke devices when used at the direction of the treating physician per the FDA approved/cleared indication. This study is designed with two cohorts that may enroll in parallel.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This is a prospective, multi-center, single arm, observational, Real World Evidence (RWE) post-market study with two cohorts.
The primary objective of Cohort I of the SOFAST study is to determine the proportion of subjects achieving successful revascularization (mTICI ≥ 2b) with the SOFIA® Flow Plus 6F Aspiration Catheter when used in conjunction with the direct aspiration as first line treatment technique for patients with acute ischemic stroke in the anterior circulation based on collection of real-world evidence data.
The objective of Cohort II of the study is to evaluate standard outcomes such as successful revascularization (mTICI ≥ 2b), good functional outcome (defined as mRS ≤ 2 at day 90), revascularization time and procedure related major neurological complications based on collection of real-world evidence data.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort I Cohort I will focus on data collection on the SOFIA® Flow Plus 6F Aspiration Catheter used with the direct aspiration as first line treatment technique with the intent to evaluate per prespecified endpoints. |
Device: SOFIA® Flow Plus 6F Aspiration Catheter with the Gomco 405 Aspiration Pump and MicroVentionTubing Kit
Patient will be treated using the direct aspiration as first line treatment technique.
|
| Cohort II Cohort II will focus on data collection on MicroVention devices used for acute ischemic stroke treatment with the intent to evaluate standard outcomes while also generating additional research questions for analysis based on data collected. |
Device: SOFIA® Flow Plus 6F Aspiration Catheter with the Gomco 405 Aspiration Pump and MicroVentionTubing Kit
Patient will be treated using the direct aspiration as first line treatment technique.
|
Outcome Measures
Primary Outcome Measures
- Cohort I: Proportion of subjects achieving mTICI ≥ 2b revascularization based on independent core lab assessment [During the procedure]
Secondary Outcome Measures
- Proportion of subjects with good functional outcome defined as mRS ≤ 2 [90 days]
- Occurrence of procedure related serious adverse events [During the procedure through study completion at 90 days]
- Occurrence of sICH within 24 hours [24 hours post-operative]
- Occurrence of embolization to new territories (ENT) [During the procedure]
- Presence of vasospasm involving the accessed vascular tree [During the procedure through 24 hours post-operative]
- Mortality at day 90 [90 days post-procedure]
- Proportion of subjects achieving mTICI ≥ 2b revascularization after first line aspiration treatment [During the procedure]
- Number of passes to achieve mTICI ≥ 2b revascularization with first line aspiration treatment [During the procedure]
- Proportion of subjects achieving mTICI ≥ 2b revascularization after first aspiration pass [During the procedure]
- Time from groin puncture to initial contact of clot with aspiration catheter [During the procedure]
- Time from groin puncture to achieve mTICI ≥ 2b using first line aspiration treatment [During the procedure]
- Technical success using the MicroVention BOBBY Balloon Guide Catheter based on successful placement at the target location and successful balloon inflation [During the procedure]
Eligibility Criteria
Criteria
Cohort I:
Inclusion Criteria:
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Patient is ≥ 21 and ≤ 85 years of age.
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Patient has a pre-morbid mRS ≤ 1.
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Neuroimaging (CT/CTA and/or MR/MRA collected at no more than 90 minutes prior to groin puncture) demonstrates large vessel proximal occlusion (distal ICA through MCA bifurcation).
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Patient has an NIHSS score ≥ 5 at time of intervention.
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Symptom onset is within 8 hours of when groin puncture can be achieved.
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Patient will undergo treatment via femoral access and the decision to use femoral access has been made by the treating physician outside the context of the SOFAST study and prior to study enrollment.
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Patient will be treated using the direct aspiration as first line treatment technique and the decision to use this technique and the study device has been made by the treating physician outside the context of the SOFAST study and prior to study enrollment.
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Patient or patient's legally authorized representative (LAR) has provided written informed consent.
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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:
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Inability to obtain written informed consent.
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Patient is < 21 or > 85 years of age.
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Patient has a pre-morbid mRS ≥ 2.
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More than 8 hours have passed since symptom onset.
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Severe unilateral or bilateral carotid artery stenosis or dissection requiring stent treatment.
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Presence of a pre-existing large territory infarction.
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Absent femoral pulses or other condition preventing femoral access.
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Patient has vascular anatomy/tortuosity or other vascular disease preventing access to the target occlusion or that will likely result in unstable access.
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Patient is pregnant.
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Known or suspected pre-existing/chronic large vessel occlusion in the symptomatic territory.
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Patient has known, untreatable hypersensitivity to contrast dye, iodine or any component of the treatment device that cannot be medically controlled.
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The intracranial occlusion is suspected to be chronic based on past imaging, clinical history, or clinical judgment.
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Patient has a severe or life-threatening comorbidity that could confound study results, or that will render the procedure unlikely to benefit the patient.
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Patient is unable to complete scheduled follow-up assessments due to comorbidities, geographical limitations, or a life expectancy of less than 3 months.
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Patient is enrolled in another device or drug study in which participation could confound study results.
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Imaging (CT or MR) exclusion criteria:
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Presence of intracerebral hemorrhage as evidenced on initial imaging
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Ischemic changes in the posterior circulation territories (including the vertebra-basilar and posterior cerebral arteries)
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Significant mass effect with midline shift
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Evidence of intracranial tumor
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Baseline ischemic core lesion >50 cc
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Involvement of > 1/3 of the middle cerebral artery territory
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ASPECTS <6 (hemispheric sulcal effacement and/or loss of grey-white differentiation alone are not contraindications for treatment)
Cohort II:
Inclusion Criteria:
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Neuroimaging demonstrates large intracranial vessel occlusion in a location representing on-label use of the intended treatment device per the FDA approved/cleared indication.
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Symptom onset is within 8 hours of when groin puncture can be achieved.
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Patient will be treated using an FDA-cleared/approved and market-released MicroVention mechanical thrombectomy device as the initial, primary treatment device and the decision to use this device has been made by the treating physician outside the context of the SOFAST study and prior to study enrollment.
Note: For the purposes of this protocol, ancillary/accessory devices such as balloon guide catheters and other access devices are not considered primary treatment devices. Further, devices used for rescue following attempt of a different primary treatment device are not considered initial primary treatment devices.
-
Patient will undergo treatment via femoral access and the decision to use femoral access has been made by the treating physician outside the context of the SOFAST study and prior to study enrollment.
-
Patient or patient's legally authorized representative (LAR) has provided written informed consent.
Exclusion Criteria:
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Inability to obtain written informed consent.
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More than 8 hours have passed since symptom onset.
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Absent femoral pulses or other condition preventing femoral access.
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Patient is enrolled in another device or drug study in which participation could confound study results.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mercy San Juan - Dignity Health Research Institute | Carmichael | California | United States | 95608 |
| 2 | Augusta University | Augusta | Georgia | United States | 30912 |
| 3 | Goodman Campbell Brain and Spine | Carmel | Indiana | United States | 46032 |
| 4 | University of Maryland | Baltimore | Maryland | United States | 21201 |
| 5 | Ascension Borgess | Kalamazoo | Michigan | United States | 49048 |
| 6 | SSM Health | Bridgeton | Missouri | United States | 63044 |
| 7 | Northshore University Hospital - Northwell | Manhasset | New York | United States | 11030 |
| 8 | Stony Brook Medicine | Stony Brook | New York | United States | 11794 |
| 9 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 10 | ProMedica Toledo | Toledo | Ohio | United States | 43606 |
| 11 | Geisinger | Danville | Pennsylvania | United States | 17822 |
| 12 | Swedish Health Services | Seattle | Washington | United States | 98122 |
Sponsors and Collaborators
- Microvention-Terumo, Inc.
Investigators
- Principal Investigator: Dheeraj Gandhi, MBBS, MD, University of Maryland, Baltimore
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CL11012