NCT03038438

ABRE Clinical Study of the Abre Venous Self-expanding Stent System

A Multi-center, Non-randomized Study to Evaluate the Safety and Effectiveness of the Abre Venous Self-expanding Stent System in Patients With Symptomatic Iliofemoral Venous Outflow Obstruction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Medtronic Endovascular · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the safety and effectiveness of the Abre venous self-expanding stent system for treatment of symptomatic iliofemoral venous outflow obstruction in patients with venous occlusive disease.

Conditions

• Iliofemoral Venous Obstruction

Interventions

Type	Name	Description
DEVICE	Abre venous self-expanding stent system	venous stent

Timeline

• Start date: 2017-12-13
• Primary completion: 2020-01-14
• Completion: 2022-01-28
• First posted: 2017-01-31
• Last updated: 2022-11-08
• Results posted: 2021-03-08

Locations

24 sites across 6 countries: United States, France, Germany, Ireland, Italy, United Kingdom

Regulatory

• FDA-regulated device study