NCT07216170

REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Microvention-Terumo, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-10-14
• Last updated: 2026-03-27

Regulatory

• FDA-regulated device study