Vascutek Anaconda™ Abdominal Aortic Aneurysm (AAA) Post-Market Surveillance Registry

NCT01744119 — Terminated, 318 participants, Vascutek Ltd.

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Vascutek Anaconda™ Stent Graft System for Infra-Renal Abdominal Aortic Aneurysm Repair

RegistryNCT01744119
StatusTerminated
Study typeObservational
Enrollment318 (Actual)
SponsorVascutek Ltd. (Industry)
ConditionsAbdominal Aortic Aneurysm
InterventionsVascutek Anaconda™ Stent Graft System (Device)
Datesstart 2005-04-01, primary completion 2016-05-01, completion 2016-05-01, first posted 2012-12-06, last updated 2016-05-24
Locations21 sites in Australia, France, Germany, Italy, New Zealand, Spain, United Kingdom

Related Papers Related Patents Related Grants Related Experts
All trials for Abdominal Aortic Aneurysm All trials of Vascutek Anaconda™ Stent Graft System

-Summary

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.

Expand all sections  ·  Collapse all

+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Abdominal Aortic AneurysmDevice: Vascutek Anaconda™ Stent Graft System
  • Vascutek Anaconda™ Stent Graft System (Device)

+Outcome measures

Primary outcomes

  • Evaluation of graft performance [60 months]: 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.
  • Graft patency [60 months]: Data will be collected and analysed on endoleak exclusion and graft migration rates
  • Exclusion of aneurysm [60 months]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patient is implanted with Anaconda™ Stent Graft System

Exclusion Criteria:

* Ruptured or symptomatic aneurysm
* Juxta or Suprarenal extension of aneurysm
* Clinically serious concomitant medical disease or infection
* Need to sacrifice both Internal Iliac Arteries due to aneurysmal dilatation
* Connective Tissue Disease (Marfan's Syndrome)
* ASA Rating of Grade IV or V
* Known allergy to Nitinol, Polyester or contrast medium
* Excessive tortuosity of access vessels (femoral or iliac arteries)
* Patients with aneurysm neck lengths of less than 15mm

+Locations (21)

FacilityCityCountryStatus
Dalcross Private HospitalKillara, New South WalesAustralia
Newcastle Private Medical SuitesNewcastle, New South WalesAustralia
Westmead HospitalWestmead, New South WalesAustralia
The Austin HospitalHeidelberg, VictoriaAustralia
Geelong Regional Vascular ServiceGeelongAustralia
Royal Perth HospitalPerthAustralia
Hollywood, Royal PerthPerthAustralia
Clinique Guillaume De VaryeSaint-DoulchardFrance
DRK Kliniken Mark BrandenburgBerlinGermany
Dresden-FriedrichstadtDresdenGermany
Klinikum GrosshadernMunichGermany
San Orsola - Bologna UniversityBolognaItaly
University federico IINaplesItaly
Guglielmo da SalicetoPiacenzaItaly
Casa di Cura Nuova ItorRomaItaly
Christchurch Hospital, CDHBChristchurchNew Zealand
Waikato HospitalHamiltonNew Zealand
Hospital Universitario Madrid MonteprincipeMadridSpain
Royal Derby HospitalDerbyUnited Kingdom
Gartnavel General HospitalGlasgowUnited Kingdom
Wishaw General HospitalWishawUnited Kingdom