NCT04072367

FIrst-Pass Reperfusion With the NeVa Stent-Retriever Trial

A Prospective, Randomized, Open-Label, Multi-Center, Assessor-Blinded Study Designed to Compare the Safety, Performance and Efficacy of the NeVatm Stent Retriever Versus the Solitairetm Stent Retriever

• Status: Withdrawn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

Summary

This study is designed to compare the safety, performance and efficacy of blood clot (thrombus) removal in subjects presenting with acute ischemic stroke with the NeVa versus the Solitaire stent retrievers.

Detailed description

A pivotal, randomized, open label, assessor-blinded, 90-day study designed to compare the safety, performance and efficacy of thrombus removal in subjects aged ≥ 18 years presenting with acute ischemic stroke with the NeVa versus the Solitaire stent retrievers. A total of 414 eligible subjects will be randomized in a 1:1 ratio to one of two treatment groups: * Active Treatment Group * Control Device

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	NeVa Stent Retrievers	thrombus removal
DEVICE	Solitaire Stent Retrievers	thrombus removal

Timeline

• Start date: 2020-12-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2019-08-28
• Last updated: 2023-04-27

Regulatory

• FDA-regulated device study