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REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke

ConditionAcute Ischemic Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMicrovention-Terumo, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • SOFIA Flow 88 Aspiration Catheter

    Device

    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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: SOFIA Flow 88 Aspiration CatheterExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of all symptomatic intracranial hemorrhage (sICH)

Time frame
24 hours post-procedure
2

Reperfusion success

Defined as independent core laboratory adjudicated modified thrombolysis in cerebral infarction (mTICI)/expanded thrombolysis in cerebral infarction (eTICI) ≥2b flow, using the SOFIA Flow 88 Aspiration Catheter only within ≤ 3 passes and without additional intraprocedural mechanical thrombectomy devices or intra-arterial thrombolytic therapy.

Time frame
During procedure

Secondary outcomes

1

Reperfusion success (defined as independent core laboratory adjudicated mTICI/eTICI ≥2b flow)

Time frame
During procedure
2

Time from arterial access to achieve mTICI/eTICI ≥2b

Time frame
During procedure
3

Incidence of mTICI/eTICI 3 reperfusion

Time frame
During procedure
4

Incidence of mTICI/eTICI ≥2c reperfusion

Time frame
During procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Microvention-Terumo, Inc.

Lead sponsor

Bright Research Partners

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: