ObJective Analysis to GaUge EVAR Outcomes Through Randomization
Research type
Research Study
Full title
JAGUAR Trial (Outside United States; OUS): ObJective Analysis to GaUge EVAR Outcomes Through Randomization
IRAS ID
301923
Contact name
Colin Bicknell
Contact email
Sponsor organisation
Endologix LLC
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
This is a an Abdominal Aortic Aneurysm (AAA) research study designed to evaluate the Alto Abdominal Stent Graft System, a device used in the treatment of people with AAA. The goal of this study is to evaluate the ongoing safety and effectiveness of the CE-marked Alto Abdominal Stent Graft System in a real-world environment compared to other commercially available similar AAA devices by collecting data on the patients'condition and the endovascular devices.
All the devices that will be assessed in this study are approved for the treatment of AAA’s and commercially available. The Alto device is made by Endologix LLC, which is the study Sponsor.
The information collected from this study will be used to evaluate how well subjects do when treated for AAA both directly after the repair of the AAA and over the following 5-years. The study will be conducted in the United States and Europe with up to 60 sites and approximately 450 subjects enrolled into the study.No matter what device is implanted, the patients will be provided the recognized benefits from the minimally invasive Endovascular Aneurysm Repair (EVAR) procedure. While there may be no direct benefit to the patients, it is hoped that the information gained from this study may benefit others with similar conditions.
This study is funded by Endologix LLC.REC name
West of Scotland REC 4
REC reference
22/WS/0111
Date of REC Opinion
29 Sep 2022
REC opinion
Further Information Favourable Opinion