NCT07357285

Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)

Prospective, Single-arm, Multi-centre Study to Evaluate the Efficacy and Safety of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO).

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (estimated)
• Sponsor: iVascular S.L.U. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, Single-arm, Multi-centre Study to Evaluate the Efficacy and Safety of the iNstroke 4F Thromboaspiration Catheter in Patients with Acute Ischaemic Stroke due to Primary Distal Medium Vessel Occlusions.

Detailed description

This study is an exploratory, interventional, open label, single-arm, multi-centre prospective clinical investigation. In this post-market clinical investigation, the aim is to further evaluate the efficacy and safety of the iNstroke 4F aspiration catheter, with a view to, in future clinical investigations, comparing the product with the standard therapy or with other similar products. In addition, this clinical investigation will generate results that could be used to further assess the safety and effectiveness of mechanical thrombectomy for the treatment of DMVO.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	Thromboaspiration catheter	Patients to undergo thromboaspiration with iNstroke 4F

Timeline

• Start date: 2025-11-27
• Primary completion: 2026-05-31
• Completion: 2026-08-31
• First posted: 2026-01-22
• Last updated: 2026-01-23

Locations

11 sites across 3 countries: Germany, Hungary, Spain