NCT03927001

The Vesalio NeVa Stent Retriever Study for Treatment of Large Vessel Occlusion Strokes

Prospective, Open-Label, Multi-Center Single-Arm Trial Designed to Assess the Safety, Performance and Efficacy of the NeVa Stent Retriever in the Treatment of Large Vessel Occlusion Strokes

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Vesalio · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A prospective, open label, single-arm 90-day study designed to assess the safety, performance and efficacy of thrombus removal in subjects presenting with acute ischemic stroke with the NeVa stent retrievers.

Detailed description

This is a prospective, open label, multi-center, single-arm trial designed to assess the safety, performance and efficacy of the NeVa stent retriever in the treatment of large vessel occlusion strokes. Up to 150 subjects at up 20 sites will participate in the study.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	NeVa Stent Retrievers	mechanical neurothrombectomy

Timeline

• Start date: 2019-04-01
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2019-04-25
• Last updated: 2023-01-17

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated device study