REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke

NCT07216170 | Withdrawn DMC FDA Device

• 1 other identifier: TER-CL-5000
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Ischemic Stroke

Keywords

Intracranial large vessel occlusive disease; Revascularization; Large bore catheter; Mechanical thrombectomy; Aspiration; SOFIA®; Direct Aspiration

Outcome Measures

Primary Outcomes (2)

• Incidence of all symptomatic intracranial hemorrhage (sICH)

  24 hours post-procedure

• 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.

  During procedure

Secondary Outcomes (10)

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

  During procedure

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

  During procedure

• Incidence of mTICI/eTICI 3 reperfusion

  During procedure

• Incidence of mTICI/eTICI ≥2c reperfusion

  During procedure

• Incidence of mTICI/eTICI ≥2b reperfusion achieved with first pass of the SOFIA Flow 88 Aspiration Catheter

  During procedure

Study Arms (1)

SOFIA Flow 88 Aspiration Catheter

EXPERIMENTAL

Device: SOFIA Flow 88 Aspiration Catheter

Interventions

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.

SOFIA Flow 88 Aspiration Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Microvention-Terumo, Inc.: lead
• Bright Research Partners: collaborator

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michael Hill, MD, MSc

  University of Calgary & Foothills Medical Centre

  PRINCIPAL INVESTIGATOR

• Charles Matouk, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2025
• First Posted: October 14, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share