NCT05720975

Efficacy and Safety Evaluation of the Thromboaspiration Catheter System iNstroke in Patients With Acute Ischemic Stroke

First Prospective, Single-arm, Single-centre Study to Evaluate the Efficacy and Safety of the Thromboaspiration Catheter System (iNstroke) for Stroke in Patients With Acute Ischemic Stroke

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 113 (actual)
• Sponsor: iVascular S.L.U. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

First prospective, single-arm, single-centre study to evaluate the efficacy and safety of the iNstroke thromboaspiration catheter system (iNstroke) for stroke in patients with acute ischemic stroke.

Detailed description

This is a prospective, single-arm, single-centre clinical safety and efficacy research. The purpose of the study is to evaluate safety and efficacy the device designed by iVascular for thromboaspiration (iNstroke) in patients who have suffered a stroke and who undergo thromboaspiration due to an acute occlusion of neuro vessels.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	iNstroke	Patients to undergo thromboaspiration with iNstroke.

Timeline

• Start date: 2022-12-26
• Primary completion: 2025-01-07
• Completion: 2025-01-07
• First posted: 2023-02-09
• Last updated: 2025-05-09

Locations

1 site across 1 country: Spain