An observational study in Abdominal Aortic Aneurysm, sponsored by Vascutek Ltd.. Terminated at 21 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-24.
Sponsored by Vascutek Ltd. · Observational
The purpose of this observational Post-Market Surveillance Registry is to gather post-market data on the performance of the CE marked Vascutek Anaconda™ Stent Graft System for the repair of Abdominal Aortic Aneurysms (AAA). The Study population consists of patients suitable for endovascular repair of AAA. Patients will be followed at 1, 3, 6, 12, 18, 24, 36, 48 and 60 months post-implantation.
Vascutek Limited, a world leader in the development of vascular grafts, has combined their latest technological developments in polyester textile technology with unique endovascular design features to produce Anaconda™, the world's next generation of AAA stent graft systems. Intuitive and of a modular design, Anaconda™ is the only repositionable device which also features exceptional flexibility. The modular design comprises bifurcate bodies, iliac legs and aortic cuffs. Nitinol, an alloy of nickel and titanium, has self-expanding properties and forms the top "ring-stent" of the bifurcate body section. The "ring stent" is composed of multiple turns of Nitinol wire that provides significantly increased "hoop-strength" enabling a conformable and secure haemostatic seal against the vessel wall to be achieved. Nitinol hooks located adjacent to the "ring stent" anchor the graft in position thus preventing graft migration. The iliac limbs are fully supported with Nitinol and the bifurcate bodies feature a distal contra-lateral lumen Nitinol support, which in conjunction with a unique intrinsic magnet guidewire system facilitates cannulation of the bifurcate section.
The system is available in a wide range of sizes thus making it a flexible and adaptable stent graft system with the potential to repair diverse patient anatomy.
960 studies on the registry are indexed under Aneurysm; 174 are open to participants now.
This study's enrollment of 318 is above the median of 151 across 443 observational studies indexed under Aneurysm.
Browse Aneurysm studies →Vascutek Ltd. is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients implanted with a CE-Marked Vascutek Anaconda™ Stent Graft System for Infra-Renal Abdominal Aortic Aneurysm Repair
Exclusion Criteria:
Device: Vascutek Anaconda™ Stent Graft System
Evaluation of graft performance
Data will be collected and analysed on system insertion and difficulty during deployment. Efficiency of the magnet system including magnet selection, ease of use and removal of magnet guidewire will also be evaluated.
Time frame: 60 months
Graft patency
Data will be collected and analysed on endoleak exclusion and graft migration rates
Time frame: 60 months
Exclusion of aneurysm
Time frame: 60 months
This study is terminated, as verified in May 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vascutek Ltd.