Not yet recruiting NCT07216170
REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SOFIA Flow 88 Aspiration Catheter.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The objective of this study is to evaluate the safety and effectiveness of the SOFIA Flow 88 Aspiration Catheter for treatment of acute ischemic stroke.
Detailed description
The investigation is a prospective, single-arm, multi-center clinical study. The study will be conducted in up to 40 investigational sites in the US, Canada, and Europe. This study will enroll up to 200 subjects, with a maximum enrollment of 30 subjects per site.
Interventions
- Device SOFIA Flow 88 Aspiration Catheter
The investigational device is the SOFIA Flow 88 Aspiration Catheter with the MV Flow Aspiration Pump and MicroVention Tubing Kit and is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 segment) within 8 hours of symptom onset.
Primary outcome measures
- Incidence of all symptomatic intracranial hemorrhage (sICH) [Time frame: 24 hours post-procedure]
- Reperfusion success [Time frame: During procedure]
Secondary outcome measures (10)
- Reperfusion success (defined as independent core laboratory adjudicated mTICI/eTICI ≥2b flow) [Time frame: During procedure]
- Time from arterial access to achieve mTICI/eTICI ≥2b [Time frame: During procedure]
- Incidence of mTICI/eTICI 3 reperfusion [Time frame: During procedure]
- Incidence of mTICI/eTICI ≥2c reperfusion [Time frame: During procedure]
- Incidence of mTICI/eTICI ≥2b reperfusion achieved with first pass of the SOFIA Flow 88 Aspiration Catheter [Time frame: During procedure]
- Incidence of mTICI/eTICI ≥2c reperfusion achieved with first pass of the SOFIA Flow 88 Aspiration Catheter [Time frame: During procedure]
- Incidence of functional independence (modified Rankin scale (mRS) ≤2) [Time frame: 90-days follow-up]
- Mortality [Time frame: 90 days post-procedure]
- Incidence of intracranial hemorrhage (ICH) [Time frame: 24 hours post-procedure]
- Incidence of Embolization to New Territory [Time frame: During procedure]
Eligibility criteria
Inclusion criteria
- Age ≥18 years on the date of consent
- National Institutes of Health Stroke Score (NIHSS) ≥6
- Alberta Stroke Program Early CT Score (ASPECTS) ≥6 assessed within 120 minutes before arterial access, defined by either baseline non-contrast computed tomography (NCCT) or baseline diffusion-weighted magnetic resonance imaging (DW-MRI)
- Angiographically suitable for endovascular intervention and the interventionalist estimates that arterial access can be achieved within 8 hours from time last known well
- Independent status immediately pre-stroke defined as ability to perform all activities of daily living as defined by mRS 0-1
- Large vessel occlusion of the intracranial internal carotid artery (ICA), middle cerebral artery (MCA) M1 segment technically accessible, as assessed during the index procedure, using a SOFIA Flow 88 Aspiration Catheter
- Subject or legally authorized representative (LAR) is willing and able to provide informed consent, as evidenced by signing and dating the IRB-approved informed consent form prior to initiation of any study-specific procedures
- Willing and able to comply with the protocol-specified procedures and assessments
Exclusion criteria
- Any intracranial hemorrhage at baseline
- Previous stroke within 90 days
- Female who is pregnant or lactating or has a positive pregnancy test at time of admission
- Arterial occlusive lesion is not technically amenable to recanalization, as assessed during the index procedure, using a SOFIA Flow 88 Aspiration Catheter (e.g., an extracranial carotid lesion prevents access, evidence of carotid dissection)
- Clinical symptoms or non-invasive imaging suggestive of or confirming bilateral stroke or stroke in multiple territories defined as multiple large vessel occlusions (e.g., bilateral proximal MCA occlusions)
- Comorbid illness that would confound the neurological or functional evaluation or is severe enough (e.g., metastatic cancer, severe congestive heart failure) such that life expectancy is <1 year or the 90-day outcome is likely to be determined by the comorbid illness
- Any contraindication to endovascular thrombectomy, such as a known history of severe contrast allergy or absolute contraindication to iodinated contrast
- Participation in another clinical trial involving an investigational mechanical device (subjects may be co-enrolled in a registry study where there is no investigational treatment).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07216170 · TER-CL-5000