ABRE Study
Research type
Research Study
Full title
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.
IRAS ID
220423
Contact name
Sarah Willey
Contact email
Sponsor organisation
Medtronic Inc
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
G160163/A001, IDE number
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
The Abre Study is 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. The purpose of the study is to 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. Currently several stents are CE-marked for this indication. The Abre system is CE marked in Europe and will be used within its intended use. A review of available literature on the use of stents for the treatment of venous obstructive disease shows that angioplasty and venous stenting are safe and effective in patients presenting with acute deep vein thrombosis, chronic postthrombotic syndrome (PTS) and chronic nonthrombotic iliac vein lesion (NIVL). The Abre system has been developed specifically for this need.
The collected data will be used to support regulatory applications to seek market approval in the US and potentially other geographies.
A maximum of 200 consented subjects will be included in the study with a hypothesis-based 30-day composite safety endpoint and a hypothesis-based 12-month effectiveness endpoint to be tested against performance goals which are based on data derived from a comprehensive literature review. Subjects who are implanted with the Abre stent will be followed for 3 years. They will have scheduled follow-up visits at 30-days, 6-, 12-, 24-, and 36-months post index procedure.REC name
London - Dulwich Research Ethics Committee
REC reference
17/LO/0797
Date of REC Opinion
31 Jul 2017
REC opinion
Further Information Favourable Opinion